Date: 2018-08-03 Category: Not Applicable State: Union Government Country: India

List of Clarifications/NOCs Issue from 2011- 2018

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

                    Okay, I will analyze the provided text and generate the policy report as requested. Given the nature of the provided document – a listing of company names, product names, intended uses, regulatory statuses, and dates – this appears to be a *listing of regulatory decisions* related to medical devices and related products, rather than a comprehensive policy document. Therefore, the report will be structured as an analysis of this *regulatory decision list*, rather than a specific "policy". This approach allows me to address the prompt even without a clear overarching policy document. Because these appear to be individual registration decisions, I will treat them collectively as reflecting policies of regulating specific devices.

**Report: Analysis of Regulatory Decision List for Medical Devices and Related Products (2011-2015)**

**1. Executive Summary:**

This report analyzes a list of regulatory decisions concerning medical devices and related products in India between 2011 and 2015. The core purpose reflected by the document is the categorization and regulation of these products as either "Regulated" or "Not Regulated." Key findings indicate a wide range of products are being assessed, spanning from surgical instruments and implants to diagnostic equipment and consumer goods. The decisions suggest an ongoing process of defining which medical products require regulatory oversight. The data provides insight into products subject to the regulatory oversight during the specified time period.

**2. Introduction:**

This report aims to provide an informative overview of regulatory decisions regarding medical devices and related products in India, based on a provided list spanning from 2011 to 2015. This report offers insight into medical and paramedical products subject to regulatory oversite for the time period specified. The report analyzes the types of products being reviewed, the regulatory status assigned to them, and potential implications of these decisions. The analysis is based solely on the information contained within the provided text.

**3. Policy Overview:**

*   Core Objective(s) as inferred from the provided text:
    *   To classify medical devices and related products as either "Regulated" or "Not Regulated" based on their intended use and risk profile.
    *   To maintain a record of these classification decisions, including company information, product names, intended uses, and dates of issue.
    *   To provide clarity to manufacturers and distributors regarding the regulatory requirements for their products.

**4. Background and Rationale:**

*   Likely problem/issue the policy addresses, inferred from the text: The list implies a need to establish a framework for regulating the medical device industry in India. Without a clear regulatory process, there is a risk of unsafe or ineffective products being marketed, potentially endangering public health. This list represents an effort to define and enforce standards within this sector.

**5. Key Provisions / Changes:**

*   Detail the main components, rules, and actions mandated by the entire provided text:
    *   The primary action reflected is the classification of medical devices. Each entry in the list represents a decision classifying a specific product as either "Regulated" or "Not Regulated."
    *   The classification appears to be based on the "Product Name" and "Intended Use" of the device. These two elements are used to determine the regulatory pathway.
    *   The list includes identifying information for the "Name of the Company and Address" responsible for the product.
    *   Each decision has a "Regulatory Status" ("Regulated" or "Not Regulated") and a "Date of Issue."
    *   The list provides a file number, likely for internal record-keeping.
    *   The decisions are issued by regulatory authorities, suggested by entries like "The AddI. Drugs Controller" and "Dy. DDC I, CDSCO North Zonr."

**6. Target Audience and Stakeholders:**

Based on the provided text, the target audience and stakeholders directly affected by this regulatory decision list include:

*   Manufacturers and distributors of medical devices and related products operating in India.
*   Healthcare providers who use these devices.
*   Patients who are the end-users of these devices.
*   Regulatory agencies responsible for overseeing the medical device industry in India.
*   Foreign companies that import/export medical devices into India.

**7. Implementation Aspects (Inferred):**

*   Responsible agency/bodies mentioned:
    *   The Central Drugs Standard Control Organization (CDSCO) is implicitly involved, as evidenced by entries mentioning "AddI. Drugs Controller" and "CDSCO."
    *   Other government departments, such as the "Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers," may play a role.
*   Any timelines or procedures specified in the text:
    *   The "Date of Issue" provides a record of when the regulatory decision was made. However, the list does not explicitly detail timelines for compliance or appeal processes. The regulatory data included in the provided data ranges from 2011 through 2015.

**8. Expected Outcomes / Impact of Changes:**

*   What are the likely intended outcomes based on the policy's stated provisions in the text?
    *   Increased clarity for manufacturers regarding the regulatory requirements for their products.
    *   Improved quality control and safety of medical devices available in the Indian market.
    *   Greater protection for patients through the regulation of higher-risk devices.
    *   Enhanced transparency in the regulatory decision-making process.

**9. Conclusion:**

The list of regulatory decisions concerning medical devices and related products between 2011 and 2015 reflects an effort to establish a regulatory framework for the industry in India. The classification of products as "Regulated" or "Not Regulated" provides guidance to manufacturers and distributors, with the ultimate goal of ensuring the safety and efficacy of medical devices available to patients. The level of detail shows which products were subjected to review during the specified time period. This type of regulatory record-keeping is a crucial step in maturing regulatory oversight for the medical device sector.
                

Key Entities Referenced

Mumbai, Maharashtra: A city in the state of Maharashtra, India, where several companies and hospitals are located as mentioned in the policy text. New Delhi: The capital city of India, mentioned as the location of several companies, government departments, and embassies. Chennai, Tamil Nadu: A city in the state of Tamil Nadu, India, featuring multiple companies and medical facilities. Gurgaon, Haryana: A city in the state of Haryana, India, identified as a location for several companies and industrial parks. Bangalore, Karnataka: A city in the state of Karnataka, India. It hosts multiple companies and facilities listed in the documents. Hyderabad, Telangana: A city in the state of Telangana, India, where several companies and research centers are located as per the text. Ahmedabad, Gujarat: A city in the state of Gujarat, India, mentioned as location of pharmaceutical industries. Pune, Maharashtra: A city in the state of Maharashtra, India, where medical and pharmaceutical companies are located as mentioned in the document. Okhla Industrial Area: An industrial area in New Delhi, India, where multiple companies are located as indicated in the text. DLF Cyber City: A corporate park in Gurgaon, Haryana, India, housing several companies mentioned in the document.

Official Source Record View Original Source →

See Full Document Text

                2011 Database
S. File . No. Name of the Company and Address Product Name Intended Use Regulatory Date of Issue
NO. Status
1 29/Misc/14/2010- M/s. Embrace, 1902 Divisadero Street, San 1. EIW 2010-002 Using Embrace Not Regulated 1/13/2011
DC(2) Francisco, CA 94115, USA Infant in Low birth
Weight Neonates
2 29/Misc/3/2010- M/s. Precision Coatings Pvt. Ltd., 101, Prince's 1. Non-woven fabric adhesive Regulated 1/31/2011
DC(82) Centre, 6/3, New Palasia, Indore-452001 (M.P) coated rolls
3 29/Misc/3/2010- M/s. Jindal Medical & Scientific Instruments 1. Sea Tangle Tents Not Regulated 1/31/2011
DC(84) Company (Pvt.) Ltd., C-53A, Mansarover (Laminara Tents) a Cervical
Garden, New Delhi-110015 Dilator
4 29/Misc/3/2010- M/s. Medicare Products Inc., C-53 A, Mansarover 1. Sea Tangle Tents Not Regulated 1/31/2011
DC(83) Garden, New Delhi-110015 (Laminara Tents) a Cervical
Dilator
5 29/Misc/3/2010- M/s. Insightra Medical Pvt. Ltd., 1201, Bldg. No. 1. Hernia repair implants Regulated 1/31/2011
DC(86) 15, Indradarshan, Phase II, Near Millat Nagar,
Andheri (W), Mumbai-400053
6 29/Misc/3/2011- The AddI. Drugs Controller, Drugs Control 1. Surgical Mesh for Hernia Regulated 1/31/2011
DC(01) Department, Government of Karnataka, Place repai and Non-woven
Road, Bangalore-01 Microporous surgical Tapes
7 29/Misc/14/2010- M/s. Cardiomedics Inc., 7 Whatney, Suite B, 1. Cardiasist External Counter Not Regulated 2/4/2011
DC(3) Irvine, CA 92618 Pulsation (ECP) System
8 29/Misc/3/2011-DC(9) Sh. Ram Chnder, Under Secretary, Department of 1. Adult Diaper Not Regulated 2/14/2011
Pharmaceuticals, Ministry of Chemicals and
Fertilizers, Shastri Bhawan, New Delhi
9 4-MD/CT-56/2010-DC M/s. Max Neeman International Limited, Max 1. Check-Cap's P1 Capsule Not Regulated 2/18/2011
House, Ground Floor, 1 Dr. Jha Marg, Okhla System in Patients eligible for
Phase III, New Delhi-110020 CRC screening10 29/Misc/3/2011- M/s. Mitra Industries (P) Ltd., 14/4, Delhi- 1. Esophageal stents, Biliary Regulated 2/18/2011
DC(04) Mathura Road, Faridabad-121003 stents, Colo-rectal Stens,
Pyloric/Duodenal stents and
Tracheobronchial stent
11 29/Misc/5/2011-DC M/s. Fenwal India Pvt. Ltd., Upper Ground Floor, 1. Thermogenesis AXP Not Regulated 2/23/2011
(Fenwal) Tower B, DLF Building No. 10, DLF Cyber City, AutoXpress System
DLF Phase II, Gurgaon-122002, Haryana
2. Manual Bag Sets having Regulated
Processing/Plasma bag with
sterile docking input line and
clot filter, RBC bag, freezing
bag total capacity: 25ml,
Cyroprotectant line with
sterile filter an intergrated
segments for sterile sample
collection
12 29/Misc/3/2010- M/s. Nobel Biocare India Pvt. Ltd., "Fortune 1. Custom made dental Not Regulated 3/7/2011
DC(77) 2000" 1st Floor, 'C' Wing, Bandra-Kurla Complex products
Bandara (E) , Mumbai-40001 2. Dental tools and accessories
13 29/Misc/3/2010- M/s. Win International Networks, Block 705, # 03-1. Air purifying 'I SIG' (Air Not Regulated 3/7/2011
DC(93) 2569, Ang Mo Kio Avenue 8, Singapore 560705 Filter + Mouth Flavourer)
14 29/Misc/3/2010- Dr. Sambhav Shah (M.S. Orthopaedic), 404, 1. Humazone Machine Not Regulated 3/8/2011
DC(96) Simla House, E Block, Nepensea Road, Mumbai-
400036
15 29/Misc/3/2011- M/s. Confident Sales India Pvt. Ltd., No. 47, 2nd 1. Synthetic Bone Graft Regulated 3/10/2011
DC(13) Floor, Pete Channappa Indl. Estate Substitute (Bone Medik)
Kamakshipalya, Magadi Road, Bangalore-56007916 29/Misc/3/2011- M/s. Romsons Juniors India Unit-II, C-1 Foundry 1. Non-Sterile bulk needles Regulated 3/15/2011
DC(14) Nagar, Agra-282006 ready for sterilization and
packing
17 29/Misc/3/2010- M/s B Braun Medical (India) Pvt. Ltd., III Floor, 1. Orthopilot Navigation Not Regulated 3/15/2011
DC(87) 23-A, Shivaji Marg, Najafgarh Road, New Delhi- System
110015
18 29/Misc/3/2011- M/s. Truskin Gloves Pvt. LTD., Plot No. 14C, 1. Sterile Surgical Gloves Not Regulated 4/6/2011
DC(31) Cochin Special Economic Zone, Kakkanad,
Cochin-682037
19 29/Misc/3/2011- Swedish Trade Council, C/o Embassay of 1. BIP Foley Catheter Regulated 4/6/2011
DC(33) Sweden, Nyaya Marg, New Delhi-110021
20 29/Misc/3/2011- M/s. Rihim Pharma Consultancy Pvt. Ltd., 518- 1. Blood Bags Regulated 4/6/2011
DC(32) 519, 5th Floor, Ring Road Mall, Mangalam Place,
Sec-3, Rohini, New Delhi-110085
21 29/Misc/3/2011- Sh. Sudhir Kumar, Under Secretary to 1. KKT Treatment Not Regulated 4/18/2011
DC(37) Government of Inida, Nirman Bhavan, New Delhi Technology
22 29/Misc/3/2011- Mr. I.K. Vijay, Swedish Trade Council, C/o 1. Components - Transmitter, Not Regulated 4/18/2011
DC(28) Embassy of Sweden, 4-5 Nyaya Marg, inserter and receiver of
Chanakyapuri, New Delhi 110021 DexcomTM Seven® PLUS
Continuous Glucose
Monitoring System
2. Sensor Regulated
23 31-731-MD/2009-DC M/s. Baxter (India) Private Limited, 2nd Floor, 1. Xenium LF Dialyzers Not Regulated 4/18/2011
End. 01 Tower C, Building 8, DLF Cyber City, DLF,
Phase II, Gurgaon-122002
24 31-731-MD/2009-DC M/s. Baxter (India) Private Limited, 2nd Floor, 1. CA-HP Dialyzer Not Regulated 4/18/2011
Tower C, Building 8, DLF Cyber City, DLF,
Phase II, Gurgaon-122002
25 29/Misc/13/2011- M/s. Boston Scientific International B.V, 100 A, 1. OPTI-MIND clinical Not Regulated 4/25/2011
DC(4) The Capital Court, Old Palme Marg, Munirka, outcomes of Pacemaker
New Delhi-110067 Patients acc. to pacing
modality and primary
indications.26 29/Misc/13/2011- M/s. Biotronik Medical Devices India Pvt. Ltd., 1. REMOTE-EVIA Registry Not Regulated 4/25/2011
DC(5) 101-106, Plot No. 14, LSC Kalkaji, New Delhii- for Pacemaker Offering
110019 Therapy Enhancement-EVIA
27 29/Misc/10/2010-DC M/s. Untied Poly Engineering Pvt. Ltd., Okhla 1. Medical Utensils and Not Regulated 4/26/2011
(United Poly Eng.) Industrial Area, Phase-II, New Delhi-110020 Hospital Furniture
28 29/Misc/5/2011- Dr. N.K. Agarwal Deputy Director Gernal 1. Contact Lens Cleaning Not Regulated 5/5/2011
DC(41) (Ophth), DGHS Nirman Bhawan, New Delhi Solution
29 29/Misc/3/2011- Allwing Lifecare, 4, Damji Shamji Ind. Complex, 1. Tranfusion Set Regulated 5/30/2011
DC(46) Off. M.C. Road, Andheri (East), Mumbai-400093 2. Infusion Set
3. Scalp Vein Infusion Set
4. A.V. Fistula Needle
5. Blood Line Tubing
30 29/Misc/5/2011-DC M/s. Mediglobe Systems, #2 Swamibathan Street, 1. Multi Sample Needle 22G 1 Regulated 6/1/2011
(M/s. Mediglobe Ramalingapuram, Chennai-600012 2. Multi Sample Needle 21G 1
System) 3. Multi Sample Needle 20G
1.5
4. Multi Sample Needle 22G
3/4
31 29/Misc/3/2011- M/s. Sisco Medical Devices (P) Ltd., 6/153, 1. Bulk Pack unsterile needles Regulated 6/7/2011
DC(47) Mount Poonamallee Road, Chennai 600089 import vide BOE No. 817509
32 29/Misc/14/2011- M/s. Max Neeman International Limited, Max 1. Digital Ballistocardiogram Not Regulated 6/9/2011
DC(7) House, Ground Floor, 1 Dr. Jha Marg, Okhla and Echocarediogram
Phase III, New Delhi-110020
33 29/Misc/3/2011- Mr. Labhesh V. Lunkad, 20/125, Anand Krupa, 1. Magnetic Device Not Regulated 6/9/2011
DC(22) Civil Hudco, Near Jain Temple, Savedi Road,
Ahmednagar, Maharashtra-414003
34 29/Misc/3/2011-DC Mr. Akash Chauhan, Senior Associate, India Law 1. Doc Laser Not Regulated 6/9/2011
(52) Officers, D-19, (GF), South Extension-I, New
Delhi-4935 29/Misc/3/2011- Sh. RK Pathni, GP Capt, O i/c RC Cell, For 1. Filter without blood bag Not Regulated 6/21/2011
DC(60) DGAFMS Raksha Mantralaya, Karyalya
Mahanideshak, Shashastra Sena Chikitsaa Sewa,
M Block, New Delhi-110001
36 29/Misc/3/2011- M/s. Friends Consolidation Ltd., #8-2- 1. Haemostatic Pad Regulated 6/21/2011
DC(61) 293/82/A/281-O, Road # 10B, Gayatri Hills,
Jubilee Hills, Hyderabad- 500033
37 29/Misc/3/2011- M/s. G.S.T. Corporation, B-13, Okhla Industiral 1. Veusable Veterinary Regulated 6/22/2011
DC(62) Area, Phase II, New Delhi-20 Needles
38 29/Misc/3/2011- M/s. B. Braun Medical (India) Pvt. Ltd., III Floor, 1. Intravenous Infusion Regulated 7/5/2011
DC(73) 23-A, Shivaji Marg, Najafgarh Road New Delhli- Administraion Sets
110015
39 29/Misc/3/2011- S-Three Sales Intl. Pvt. Ltd., D-9, Jangpura 1. Safest Blood Samplling Regulated 7/5/2011
DC(68) Extension, New Delhi-110014 System
40 29/Misc/3/2011- M/s. PAT Pharma Consultants India Pvt. Ltd., 1. Velumount Not Regulated 7/5/2011
DC(67) Unit No. 2nd Floor, Vikas Surya Arcade, Plot No.
7, CU Block, Pitampura, Delhi-110088
41 29/Misc/3/2010- M/s. Reevax Pharma Limited, 502 Rohini Apt. 1. XOIN (A topical tissue Regulated 7/18/2011
DC(17) Srinagar Colony Road, Hyderabad-500073 AP adhesive)
42 29/Misc/14/2011- M/s. Max Neeman International Limited, Max 1. ALERTS (Angelmed for Not Regulated 8/9/2011
DC(8) House, Ground Floor, 1 Dr. Jha Marg, Okhla early recognition and
Phase III, New Delhi-110020 treatment of STEMI)
43 29/Misc/3/2011- M/s. Nipro India Corporation Pvt. Ltd., 503/504 1. Dialyzer Not Regulated 8/24/2011
DC(86) Sai Capital, Opp. ICC Tech Park, Senapati Bapat
Road, Pune 411016
44 29/Misc/3/10-DC(92) M/s. Precision Coatings Pvt. Ltd., 101, Prince's 1. I.V. Dressing by way of Regulated 9/6/2011
Centre, 6/3, New Palasia, Indore-452001 (M.P) inclusion in the existing
manufaccturing licesne
45 29/Misc/3/2011- M/s. G.S.T. Corporation, B-13, Okhla Industiral 1. Reusable Veterinary Regulated 9/20/2011
DC(62) Area, Phase II, New Delhi-20 Needles
46 29/Misc/3/10-DC(29) M/s. Fresinius Kabi India Pvt. Ltd., Echelon 1. Feeding Tubes: Freka Tube Not Regulated 9/20/2011
Institutional Area, Plot No. II, Sector-32, Gurgaon-
12200147 29/Misc/3/2011- M/s. Ypsomed India Pvt. Ltd., 10/61/1 F, Kirti 1. Lancet Needles Not Regulated 9/20/2011
DC(97) Nagar, Industiral Area, New Delhi-110015
48 29/Misc/3/2011- M/s. Emergo India Consulting Private Limited, 1. Ulthera System Not Regulated 9/21/2011
DC(105) 8/1, First Floor, Vasavi Colony Kakguda, Near
Picket, Secunderabad-500009 (A.P)
49 29/Misc/3/2011- M/s. Emergo India Consulting Private Limited, 1. Viberect™ Penile Not Regulated 9/21/2011
DC(104) 8/1, First Floor, Vasavi Colony Kakguda, Near Vibratory Stimulation device
Picket, Secunderabad-500009 (A.P)
50 29/Misc/3/2011- M/s. Becton Dickinson India Pvt. Ltd., 5th & 6th M/s. BD Oralpak™ Oral Not Regulated 9/21/2011
DC(54) Floor, Signature Tower-B, South City-I, Gurgaon- Dosing Dispenser
122001
51 29/Misc/3/2011- M/s. 12iHealth Trading Pvt. Ltd., 413/414 Oxford 1. LungFlute Not Regulated 9/27/2011
DC(91) Tower, 139 Old Airport Road, Kodihalli (Opp.
Leela Place), Bangalore-560008
52 29/Misc/3/2011- M/s. Swedish Trade Council C/o Embassay of 1. Digital Cardio Rhythm Not Regulated 9/30/2011
DC(98) Sweden, New Delhi Analyzer-Dinamika
53 29/Misc/3/2011- M/s. Sagar Fossil Fuel Technologies Private 1. Orthopaedic Bandages (For Regulated 9/30/2011
DC(78) Limited, 257-A, 1st Floor, Hauz Rani Market, External Use)
Press Enclave Road, New Delhi-110017
54 29/Misc/3/2011- Dr. K.M. Cherain's, Froniter Lifeline Hospital (A 1. Organ Chamber Not Regulated 9/30/2011
DC(94) unit of Frontier Lifeline P. Ltd.) R-30-C,
Ambattur Industrial Estate Road, Chennai-600101
55 29/Misc/3/2011- M/s. Allwin Lifecare, 4, Damji Shamji Industrail 1. Blood Collection Bags with Not Regulated 9/30/2011
DC(93) Com. Off Mahakali Caves Road, Andheri (East), Anticoagulant CPD A1.
Mumbai-400093, Maharashtra 2. Blood Collection Bags with
Anticoagulant CPD SAGM.
3. Transfer Pack56 29/Misc/3/2011- M/s. Lotus Surgical Pvt. Ltd., 4, Gitanjali, 1st 1. Skin Staplers Regulated 10/18/2011
DC(112) Floor, Plot No. 116-A, Road No. 24-A, Sion
(West), Mumbai-400022
57 29/Misc/3/2011- M/s. GST Corporation, B-13, Okhla Industrial 1. Latex Male Regulated 10/25/2011
DC(120) Area, Phase-II, New Delhi-110020 Catheter/Connector
58 29/Misc/3/2011- M/s. Combindia Biotech Kits (Pvt.) Ltd/. 208, 1. Evacuated Blood Collection Regulated 10/25/2011
DC(113) Partik Industrial Estate, Mulund- Goregaon Link Needles Multi Drawing
Road, Next to Wockhardt Hospital, Mulund Needles 22x1
(West), Mumbai-400078
59 29/Misc/3/2011- M/s. Nirmal Biotech, E/2, Manjaplur, Township 1. Silicone Oil and Intraocular Regulated 10/25/2011
DC(108) No. 1, Opp. Sandalwood, Soc. Manjalpur, Gases
Vadodara-390011, Gujarat
60 29/Misc/3/2011- M/s. Allergan India Private Limited, Lvel-2, 1. Eyegiene Not Regulated 10/25/2011
DC(116) Prestige Obelisk No. 3, Kasturba Road,
Bengaluru-560001
61 29/Misc/3/2011- M/s. LIV Medica, 2-395, Mookamblga Nagar, 1. First Aid Kits for exports Regulated 11/11/2011
DC(50) Kattupakkam, Chennai-600056
62 29/Misc/3/2011- M/s. Akraya Energy International Pvt. Ltd., 621, 1. Cold Dry (Ice Sterile) Use for Analgesic, Regulated 11/11/2011
DC(92) Galleria Office Complex, DLF Phase IV, Anti-inflammatory,
Gurgaon-122002 Anti-edema action
63 29/Misc/3/2011- M/s. Global Trade Resources 212, Ansal 1. Fever Cooling Patch Regulated 11/11/2011
DC(119) Chember-II, Bhikhaji Cama Place, New Delhi-
110024
64 29/Misc/3/2011- M/s. Emergo India Consulting Private Limited, 1. CellTrans ABT Post- Regulated 11/21/2011
DC(106) 8/1, First Floor, Vasavi Colony Kakguda, Near operative Blood Transfusion
Picket, Secunderabad-500009 (A.P) System
65 29/Misc/3/2011- M/s. LIV Medica, 2-395, Mookamblga Nagar, 1. Adhesive Bandages Regulated 11/21/2011
DC(124) Kattupakkam, Chennai-600056
66 29/Misc/3/2011- M/s. Virdis Biopharma Pvt. Ltd., 6/10 Jogani 1. Substance P As wound healing Regulated 11/21/2011
DC(118) Industrial Complex, V.N. Purav Marg;, devices
Chunabhatti, Mumbai-022
67 29/Misc/3/2010- M/s. Smith & Nephew Healthcare Pvt. Ltd., 203 1. IV 3000 and OpSite Not Regulated 11/21/2011
DC(99) B, Dynasty Business Park, Andheri Kurla Road, Flexifix
Andheri (East), Mumbai-40005929/Misc/3/2010- M/s. Smith & Nephew Healthcare Pvt. Ltd., 203 11/21/2011
DC(99) B, Dynasty Business Park, Andheri Kurla Road,
68 Andheri (East), Mumbai-400059 2. Opsite Incite and Opsite Regulated
Post-op
69 29/Misc/3/2011- M/s. Bhabha Atomic Research Centre Hospital 1. Used for Manula removal Not Regulated 11/22/2011
DC(127) Anushaktinagar, Mumbai-400094 of stool/faeces
70 29/Misc/14/2011- M/s. Max Neeman International Limited, Max 1. Multi Acting Nasal particle Not Regulated 11/22/2011
DC(10) House, Ground Floor, 1 Dr. Jha Marg, Okhla Blocker (MAPB)
Phase III, New Delhi-110020
71 29/Misc/10/2010-DC Sh. Narendra Vashista, Foreigen Trade 1. Othopaedic Implants Regulated 11/24/2011
(S.H. Pitkar Development Officer, Ministry of Commerce &
Orthotools) Industry, Government of India, DGFT, Udyog
Bhavan, New Delhi
72 29/Misc/3/2011- M/s. Smith & Nephew Healthcare Pvt. Ltd., 203 1. PICO Pump Not Regulated 12/7/2011
DC(126) B, Dynasty Business Park, Andheri Kurla Road, 2. Dressing and Stirips Regulated
73 29/Misc/3/2011- Mr. B.S. Kain, (Section Officer) Nirman Bhavan, 1. Latex Male Connector Not Regulated 12/9/2011
DC(120) New Delhi
74 29/Misc/3/2011- Mr. B.S. Kain, (Section Officer) Nirman Bhavan, 1. Re-Usable, Non-Sterile Not Regulated 12/9/2011
DC(121) New Delhi Needle for suture
75 29/Misc/3/2011- The ADC(I), CDSCO Sub Zonal Ahmedabad, 1. Dental Implants Regulated 12/9/2011
DC(135) Aire Cargo Complex Old Terminal Building,
Airport Ahmedabad-380016
76 29/Misc/3/2011- M/s. G.S.T. Corporation, B-13, Okhla Industiral 1. Re-Usable, Non-Sterile Not Regulated 12/9/2011
DC(121) Area, Phase II, New Delhi-20 Needle for suture
77 29/Misc/3/2011- M/s. Stericat Gutstrings(P) Ltd., 169, Sector-4, 1. Sterile Monofilament Regulated 12/9/2011
DC(134) IMT Manesar, Gurgaon, Haryana-122050 Polypropylene Mesh
78 29/Misc/3/2011- M/s. A S Smokefree Electorinc Cigarette Pvt. 1. Electronic Cigarette Not Regulated 12/9/2011
DC(144) Ltd., G-4, Southx-2, New Delhi-110048
79 29/Misc/3/2011- M/s. Abbott Medical Optics Private Limited, The 1. Contact Lens Care Products Used for cleaning Not Regulated 12/9/2011
DC(96) Masterpiece, Level-5, Golf Course Road, Sector- of proteings
54, Gurgaon-122002 Haryana from contact
lenses
80 29/Misc/3/2011- M/s. Wellset Ortho, No. 402, Gokul Classic, 1. Fiberglass Casting Tape Regulated 12/9/2011
DC(138) Above Karur Vysya Bank, Nizampet Road,
Hyderabad-500072
2. Water repellent Underpad Not Regulated81 29/Misc/3/2011- M/s. One Touch Medical Products (P) LTD., 1. Non Sterile Needle Ready for Regulated 12/9/2011
DC(128) 2h/78, Bahadurpur Housing Colony Kankarbagh, sterilization,
Patna-800026 labeling and
packing
82 29/Misc/3/2011- M/s. Fresenius Kabi India Pvt. Ltd., A-3, MIDC, 1. Giving set for infusion Used for infusion Regulated 12/20/2011
DC(141) Rajangaon, Ganpati Tal. Shirur, Dist. Pune pump- Volumet lines of I.V. Fluid/
Durgs etc
83 29/Misc/3/2011- M/s. B. L. Lifesciences Pvt. Ltd., A-245, Okhla 1. HYPOTHERMOSOL 1. Used for Not Regulated 12/20/2011
DC(139) Industrial Area, Phase-I, New Delhi-110020 2. CRYOSTOR preservation of
3. BLOODSTOR cells
2. Used for
protective
environment
for cells and
3. Used for
cryoperservation of
stem
cells
84 29/Misc/3/2011- Sh. R. K. Pathni (G.p. Capt) O i/c RC Cell 1. Vacuumised Tubes Not Regulated 12/20/2011
DC(137) Raksha Mantralaya, Karyalaya Maha Nideshak, 2. Disposable Hypodermic Regulated
Sashastra Sena Chikitsa Sewa, 'M' Block, New Needles
85 29/Misc/3/2011- M/s. Manish Enterprises, 2/19, Bhuta Nivas, Dr. 1. I.V. Fixator Used to holds I.V. Not Regulated 12/23/2011
DC(148) Ambedlar Road, Matunga, Mumbai-400019 Cannula
86 29/Misc/3/2011- M/s. Smith & Nephew Healthcare Pvt. Ltd., 203 1. Trigen Sureshot Distal Not Regulated 12/30/2011
DC(151) B, Dynasty Business Park, Andheri Kurla Road, Targeting System
Andheri (East), Mumbai-400059
87 29/Misc/3/2011- M/s. Emergo India Consulting Private Limited, 1. VibeX Regulated 12/30/2011
DC(149) 8/1, First Floor, Vasavi Colony Kakguda, Near 2. Avendro Inc.'s KXL Not Regulated
Picket, Secunderabad-500009 (A.P) Systems's2012
Dat
abas
S. File . No. Name of the Company and Address Product Name Intended Use Regulatory Status Date of
NO. Issue
1 29/Misc/3/201 M/s. Beauvana Biotech 1. Intermesh Soft Lift, Intermesh T-1,Biomesh-P1, 4D-DOME, Regulated 1/3/2012
1-DC(153) Pvt. Ltd., 6/7 A, Selva BIOMESH Soft-P9, BIOMESH Soft Prolapse, BIOMESH
Ratna Vinayagar Ave, Light-P8, BIOMESH-A2, CABS-AIR composite and Biomesh
Cart Tract Road, Velchery, Soft Prolaps-Cystocele Hernia Mesh
Chennai-600042
2 29/Misc/3/201 M/s. Beauvana Biotech 1. Bioring Gastric Lap Regulated 1/3/2012
1-DC(123) Pvt. Ltd., 6/7 A, Selva Brand
Ratna Vinayagar Ave,
Cart Tract Road, Velchery,
Chennai-600042
3 29/Misc/3/201 The Director, Directorate 1. Smallbore Y- Connector Regulated 1/3/2012
1-DC(72) of Food & Drugs Admn., Extension Set, 2 Needle- Free Valves, Spin male luer lock
Old I.P.H.B. Complex, 2. Smallbore Tri- port extension set, 3 needle - Free Valves,
Altinho, Panji-Goa Fixed male luer lock
3. Extension set, 2 needle-free valves, spin male luer lock
4 29/Misc/3/201- M/s. Pacific Bridge Medical India, 117, Pratap 1. Heart Mate - II Left Ventricular Assist System (LVAS) Not Regulated 1/17/2012
DC(163) Complex, Partap Market, Munirka, New Delhi-
110067
5 29/Misc/3/201 M/s. Medicaid Agencies, 204, Shivlok House-II, 1. Bone Injection Gun Regulated 1/24/2012
1-DC(168) Karmapura Comm. Complex, New Delhi-110015
6 29/Misc/3/201 M/s. Emergo India Consulting Private Limited, 8/1, 1. Spiro PD Used for Not Regulated 1/24/2012
1-DC(169) First Floor, Vasavi Colony Kakguda, Near Picket, measurement
Secunderabad- 500009 (A.P) of air flow &
volume
of lungs
7 29/Misc/3/201 M/s. A. B. Dental Devinces Ltd., Park Hanada, 3 1. Dental Implant and Abutments Regulated 1/24/2012
1-DC(167) Habosem St. Ashdod Israel8 29/Misc/3/201 M/s. Sanzyme Ltd., Plot No. 13, Sagar Society, 1. Invo Cell™ Use in preparing, Not Regulated 1/31/2012
1-DC(152) Road No. 2, Banjara Hills, Hyderabad-500034 storing,
manipulation or
transferring
human gametes or
9 29/Misc/3/201 M/s. Indian Hygiene Products Co., 176, Bara 1. Ribbel Ultra Comfort Adult Diaper Not Regulated 2/13/2012
1-DC(166) Bazar, Kolkata-6
10 29/Misc/3/201 M/s. B. Braun Medical Indian Pvt. Ltd., II Floor, 1. Neuro- Patch and Lyoplant Used as a Dura Regulated 2/14/2012
1-DC(162) 23-A, Shivji Marg, Najafgarh Road, New Delhi- substitute
110015 in any intracranial
and
Intraspinal Dura
11 29/Misc/3/201 M/s. B. Braun Medical Indian Pvt. Ltd., II Floor, 1. YASARGIL Aneursym Clip Regulated 2/14/2012
1-DC(109) 23-A, Shivji Marg, Najafgarh Road, New Delhi-
110015
12 29/Misc/3/201- M/s. Gentech Laboratories Ltd., Gala No. 401, 4th 1. Injex Needle Free Injection Devices Regulated 2/14/2012
DC(170) Floor, Marol Bhawan, Marol Co-op Indl Estate,
J.B. Nagar, Andheri-East, Mumbai-400059
13 29/Misc/3/201 M/s. Synthes Medical Pvt. Ltd., Plot No. 118-P, 1. Customs made Implant - PEEK bone replaacement Implant Not Regulated 2/27/2013
2-DC(02) Sector-44, Gurgaon (Non-sterile)
14 29/Misc/3/201 Mr. P.B.N. Prasad, Deputy Drugs Controller (I), 1. Non sterile Bulk Syringes W/o Needle Regulated 3/1/2012
2-DC(21) CDSCO, South Zone Second Floor, Shastri
Bhawan Annexe, 26, Haddows Road, Chennai-
600006
15 29/Misc/3/201 M/s. Emergo India Consulting Private Limited, 8/1, 1. EHY - 2000 Plus Not Regulated 3/1/2013
2-DC(15) First Floor, Vasavi Colony Kakguda, Near Picket,
Secunderabad- 500009 (A.P)
16 29/Misc/3/201 M/s. NXT Medical Devices Pvt. Ltd., 19, 1st 1. Dru Inhaler without any Drugs Used for asthma Not Regulated 3/1/2012
2-DC(18) Street, Parthasarathy Nagar, Adambakkam, patients
Chennai-88
17 29/Misc/3/201 M/s. Medsurge Ind Private Limited, New No. 7, 1. Surgical Disposable Products: Plastibell, Amni Hook, Urine Not Regulated 3/1/2012
1-DC(150) Old No. 4, 1 Cross Street, Shasthri Nagar, Adyar, Bag, Umbilical Cord Clamp
Chennai-60002018 29/Misc/3/201 M/s. Buoyant Medicos, 47/12, LGF, Old Rajinder 1. Hematrix- acive patch wound dressing for immediate Used on external Regulated 3/1/2012
2-DC(10) Nagar, New Delhi Haemostasis wounds
to stop even severe
arterial or venous
bleeding
19 29/Misc/3/201 M/s. Nirma Limited, Nirma House, Ashram Road, 1. Non sterile Bulk Syringes Regulated 3/1/2012
2-DC(11) Ahmedabad-380009
20 29/Misc/3/201 M/s. U & N Commercial Consultancy, D003 Casa 1. Bioelectrical Impedance Analysis (BIA) Devices Not Regulated 3/1/2012
2-DC(14) Ansal Apartments, No. 18, Bannerghatta,
Bangaluru - 560076
21 29/Misc3/2012-M/s. Delhi Ey Zone Pvt. Ltd., D-114, (G.F.), Lajpat 1. Labtician Retinal Implants Used in the Not Regulated 3/1/2012
DC(08) Nagar-I, New Delhi-110024 treatment
of retinal
detachments
22 29/Misc/3/201 M/s. KMS Medisurgi Pvt.Ltd., 44, Mangaldas 1. Micro Foam Surgical Tape Used for securing Not Regulated 3/6/2012
2-DC(12) Road, Bulakhidas Bldg, Gr. Floor, Mumbai- 400 dressings on
002 challenging
areas
23 29/Misc/3/201 M/s. Bausch + Lomb India Pvt. Ltd., 2nd Floor, 1. Lens Care Solutions and Soft Contact Lenses Not Regulated 3/6/2012
2-DC(16) Tower A, Buliding No. 8, DLF Phase II, DLF
Cyber City, Gurgaon - 122002
24 29/Misc/10/20 Sh. Samir Sinha, Foreign Trade Development 1. Gauze Rolls Used for Wound Regulated 3/6/2013
12-DC-1 Officer, Ministry of Commerace and Industry, dressings
(GSK) DGFT, Udyog Bhavan, New Delhi (Surgical
Dressings)
25 29/Misc/3/201 M/s. 3 M India Limited, Plot Nos. 48-51, 1. Fluid Warming system Used for to Not Regulated 3/9/2013
1-DC(143) Electronics City, Hosur Road, Bangalore-560100 generate
temperature
26 29/Misc/3/201 M/s. 3 M India Limited, Plot Nos. 48-51, 1. 3M Ranger Blood Dissposable I.V. Regulated 3/9/2013
1-DC(143) Electronics City, Hosur Road, Bangalore-560100 Adminstration set
(Ranger lood)
27 29/Misc/3/201 M/s. Medi Globe Systems, # 22, Pandaram Street, 1. Tube Holder and Vacuum Tube Not Regulated 3/29/2012
2-DC(25) Purasaiwakkam, Chennai- 600007
28 29/Misc/3/201 M/s. Medi Globe Systems, # 22, Pandaram Street, 1. Double Ended Needle (Multi sample Needle) Regulated 3/29/2012
2-DC(25) Purasaiwakkam, Chennai- 600007
29 29/Misc/3/201 M/s. Medihauxe International, Shreedharma, 1. NexTemp Single use Clincial thermometer, Traxit Wearable Not Regulated 4/3/2012
2-DC(30) 2676/20, 11th Main, D Block, 2nd Stage Thermomr, NexTemp Reusable Clinical Thermometer with a
Rajajingar, Bangalore- 560010 Carrying Card Holder, NexTemp Plus Rectal Sheath, Nextemp
Standard Clinical Oral Thermometer30 29/Misc/3/201 M/s. 3 M India Limited, Plot Nos. 48-51, 1. Scotchast Premium Casting Tape Regulated 4/3/2012
2-DC(24) Electronics City, Hosur Road, Bangalore-560100
31 29/Misc/3/201 M/s. Alcon Laboratories (I) Pvt. Ltd., No. 3, 5th 1. Acrysof Restor 1Q Multifocal Toric Intraocular Lens Not Regulated 4/3/2012
2-DC(31) Floor, RM Infinity Tower D, Unit No. 502, Old
Madras Road, Benniganahallo, Bangalore-560016
32 29/Misc/5/201 Dy. DDC (I), CDSCO (North Zonr) 1st Floor, 1. Auction of Biolox forte (An Orthopaedic Implant ) Regulated 4/3/2012
2-DC(09) Central Govt. Office Building- I, Kamla Nehru
Nagar (Central Govt. Enclave), Hapur Road,
Ghaziabad- 201002
33 29/Misc/3/201 M/s. In Vitro Medical Solutions (P) Ltd., E-291, 1. Vacuum & non vacuum tubes, Lencet Tourniquets and Not Regulated 4/4/2012
2-DC(07) Sarita Vihar, New Delhil-110076 Needle Holder
34 29/Misc/3/201 M/s. In Vitro Medical Solutions (P) Ltd., E-291, 1. Multi Sample Needle (Pen Type and Butterfly Type) Regulated 4/4/2012
2-DC(07) Sarita Vihar, New Delhil-110076
35 29/Misc/3/201 M/s. Juno Pharma, 3rd Floor, Harith Arcade, D. 1. Actipatch Use for relief o f Regulated 4/4/2012
2-DC(09) No. 3- 100/2/B, Survey No. 277, Nizampet Road, Acute
Hyderabad-500090 and chronic pain,
Inflammation and
swelling, stains
and
sprains
36 29/Misc/14/20 M/s. St. Jude Medical India Pvt. Lt., No. 1-11-250 1. Pacemakers Not Regulated 4/10/2012
11-DC(12) A, Matarani Sensation, Begumpet, Hyderabad 2. Leads
500016, India
37 29/Misc/3/201- M/s. UP Dental Products Pvt. Ltd., 107, 1st Floor, 1. Porcelain Etch & Silane 1. For Etching Not Regulated 4/10/2012
DC(56) Sai Commercial Centre, Mumbai - 400088 2. Sable Seek Porcelain and
3. VALO Preparation for
4. Sof-Tray Classic Sheets bonding.
5. Ultracal 2. Indicator Stain
6. Ultra-blend plus 3. Curing Light
7. File-Eze 4. Tray Fabricating
Sheet
5. Lining and
Capping
6. Cavity Liner
7. Solution for
cleaning
and chelating a
Root Canal38 29/Misc/3/201 M/s. Varian Medical Systems India Software Pvt. 1. Calypso Used to detect Not Regulated 4/10/2012
2-DC(45) Ltd., Tower XL, Level 7, Cybercity Magarpatta, cancer organ
Hadapsar, Pune-411013 movement during
radiation treatment
39 29/Misc/3/201 M/s. SkinCare Surgipharma Pvt. Ltd., Shop No. 7, 1. Oragrafts (Bone Graft) Not Regulated 4/10/2013
2-DC(41) Salamat Mansion (Opp. Ravindra Natya Mandir), 2. RediGrafts (Bone Graft)
Sayani Road, Prabhadevi, Mumbai- 400025 3. FlexiGrafts (Tissue Graft)
40 29/Misc/3/201 M/s. Arun & Co., 601/A & 602/B Polaris, off 1. Diagnostic Enzymes- Panicillinase Used in Laboratory Not Regulated 4/17/2012
2-DC(43) Marol Maroshi Road, Marol, Andheri (East), 2. B-Lactamase
Mumbai-400059
41 29/Misc/3/201 M/s. ClinTech India, Plot # 222, Sabari Aangan, 1. Hemo Rite Used is for Not Regulated 4/17/2012
2-DC(03) 11th Road, Chembur, Mumbai-400071 treatment of
hemorrhoids by
Cryotherapy
42 29/Misc/3/201 M/s. Emergo India Consulting Private Limited, 8/1, 1. SPATZ®Adjustable Balloon System Used for weight Regulated 4/17/2012
1-DC(57) First Floor, Vasavi Colony Kakguda, Near Picket, loss by partially
Secunderabad- 500009 (A.P) filling in the
stomach and
Provent therapy
NASAL Cannula
Diagnostic Kit
consisting of
provent nasal
cannula & provent
Device- intended
for the treatment of
in obstrucive sleep
apnea
43 29/Misc/3/201 M/s. Emergo India Consulting Private Limited, 8/1, 2. Epiflo® Transdermal Continous oxygen therapy Intended to deliver Not Regulated 4/17/2012
1-DC(57) First Floor, Vasavi Colony Kakguda, Near Picket, pure oxygen to the
Secunderabad- 500009 (A.P) wounds
44 29/Misc/14/20 M/s. Vascular Concepts Ltd., 7C, Doddaballapur 1. Pronova CC-Sirolimus Eluting Stent Regulated 4/18/2012
12-DC(2) Industial Estate, Doddaballapur, Bangalore-561203
45 29/Misc/14/20 M/s. Vascular Concepts Ltd., 7C, Doddaballapur 1. Pronova XR-Sirolimus Eluting Stent Regulated 4/18/2012
12-DC(1) Industial Estate, Doddaballapur, Bangalore-56120346 29/Misc/3/201 M/s. Chayagraphics (India) Pvt. Ltd., #249, 4th 1. Syringes and Low Pressure Disposable for CT/MR/Angio Used in the contrast Regulated 4/24/2012
2-DC(46) Main Road, Chamarajpet, Bangalore-560018 Injectors media injectors,
hence Syringes and
Low Pressure
Disposable for
CT/MR/ Angio
Injectors
47 29/Misc/3/201 M/s. Int'l Marketing & Development, The Bucley 1. Sharps Terminator TM Destroys a wide Not Regulated 4/24/2012
2-DC(51) Group LLC, 4455 South Group Padre Island Drive range of disposable
Suite #5, Corpus Christi, TX 78411 needles
48 29/Misc/3/201 M/s. Kindegarten Rehab Suppliers, 14, M.P. Jain 1. Kinesio Tape Involves taping Not Regulated 4/24/2012
1-DC(111) Compound Raheja Township, Mald (East), over and around
Mumbai-400097 muscles to prevent
over contraction
49 29/Misc/3/201 M/s. Rejen Biomedical Pvt. Ltd., 401 Bhaveshwar 1. Chemablate Intended to ablate Regulated 4/26/2012
1-DC(187) Complex, Vikyavihar (W), Mumbai-86 the endometrial
lining of the uterus
in women the
Menorrhagia
50 29/Misc/3/201 M/s. Span Healthcare Pvt. Ltd., Columbus 1. SCOUT DS Invasive Diabetes screening device Intended to analyze Not Regulated 4/26/2012
2-DC(36) Business Chambers, #17, 7th Temple Street, 15th the level of glucose
Cross Malleswaram, Bangalore-56003 in human blood
51 29Misc/3/2012-M/s. Care Fusion, Tower D, Second Level, DLF IT 1. SmartSite Used as a self Regulated 4/26/2012
DC(27) Park, Kishangarh, Chandigarh sealing connector
52 29/Misc/3/201 M/s. B. Braun Medical Indian Pvt. Ltd., II Floor, 1. Infuvalve Back Check Valve Used as a accessory Regulated 4/26/2012
1-DC(130) 23-A, Shivji Marg, Najafgarh Road, New Delhi- for infusion therapy
110015 to prevent back
flow into infusion
lines53 29/Misc/3/201 M/s. Emergo India Consulting Private Limited, 8/1, 1. Nanosonic Trophon EPR System Consists of a Not Regulated 5/1/2012
2-DC(47) First Floor, Vasavi Colony Kakguda, Near Picket, multiple use
Secunderabad- 500009 (A.P) instrument,
combined with a
single use
disinfectant which
is delivery form
multi dose cartridge
Hydrogen peroxide
54 29/Misc/3/201 M/s. Emergo India Consulting Private Limited, 8/1, 1. Nanosonic Trophon EPR System Multi Cartridge of Regulated 5/1/2012
2-DC(47) First Floor, Vasavi Colony Kakguda, Near Picket, Hydrogen Peroxide
Secunderabad- 500009 (A.P) Disifnectant
55 29/Misc/3/201 M/s. S.B. Medicare Pvt. Ltd., A-258, Defence 1. Ligating Clips (Polymer/Titanium) Intended for Regulated 5/1/2012
2-DC(55) Colony New Delhi-110024 ligating of any
tissue structures or
vessels during
operation for
haemostasisis
56 29/Misc/3/201 M/s. Synthes Medical Pvt. Ltd., Plot No. 118-P, 1. VBS S/M/L Vertebral Body Stenting System Not Regulated 5/1/2012
2-DC(53) Sector-44, Gurgaon
57 29/Misc/3/201 Sh. Greh Pal Singh, 480, Double Story, (G.F). New 1. Minitype of Air Filtration Device, which may supply Not Regulated 5/3/2012
2-DC(57) Rajinder Nagar, New Delhi-110060 infection free air
58 31-188- M/s. Synthes Medical Pvt. Ltd., Plot No. 118-P, 1. Cable System For Orthopaedic Regulated 5/8/2012
MD/2006- Sector-44, Gurgaon Trauma Surgery
DC(Re-Reg and Intended use as
2009) periprosthetic
fractures,
temporary
reduction
59 29/Misc/14/20 M/s. Max Neeman International Limited, Max 1. Cyberonics Vagus Nerve Stimulation (VNS) therapy system Not Regulated 5/8/2012
12-DC (3) House, Ground Floor, 1 Dr. Jha Marg, Okhla Phase
III, New Delhi-110020
60 29/Misc/14/.20 M/s. Lumenis India Pvt. Ltd., Unit No. : 308-310, 1. Light Sheer Duet Not Regulated 5/15/2012
12-DC(4) 3rd Floor, Suncity Business Tower, Sector-54, Golf
Course Road, Guragaon-12202 Haryana61 29/Misc/3/201 M/s. Eisai Pharmaceutical India Private Limited, 1. DC Bead & Bead Block Regulated 5/23/2012
2-DC(01) 1st Floor, B Wing, Marwah Centre, Krishanlal,
Marwah Marg, Andheri (East), Mumbai-400072
62 29/Misc/3/201 M/s. Millenium Biotch, J-6/98, Second Floor, 1. Comfort Bath, Comfort Shampoo Cap Used for the Regulated 5/23/2012
1-DC (171) Rajori Grden, New Delhi-110027 purpose of
cleansing human
body or
its part(s)
63 29/Misc/3/201 M/s. Millenium Biotch, J-6/98, Second Floor, 1. Antiseptic Body Washcloth, Comfort Shield Barrier Cloth Regulated 5/23/2012
1-DC (171) Rajori Grden, New Delhi-110027
64 29/Misc/3/201 M/s. Delhi Ey Zone Pvt. Ltd., D-114, (G.F.), Lajpat 1. Ferrara Ring an Intracorneal Implants Used for correction Not Regulated 5/23/2012
2-DC(56) Nagar-I, New Delhi-110024 of patholigical
tissue deformities
of the cornea
65 29/Misc/3/201 M/s. Krisna Patient Care Systems India Pvt. Ltd., 1. Drug Free Pain Relief TransCare Medical Devices-Ova, Not Regulated 5/23/2012
2-DC(29) M-28, 3rd Floor, G K (Greater Kailash)-II, M- Itourch Eas, Itouch Sure, Itouch tone, Touch Tens, Mamatens,
Block Market, New Delhi-110048 Sport Tens, and Ultima IF4160
66 29/Misc/3/201 M/s. Paul Hartmann Medical Private Limited, 1. Various non woven compund/Multiplayer compound - Regualted 5/23/2012
2-DC(06) Regus Suburb Centre Private Ltd., Level-4, Drape Sheets for various operations/ surgeries
Dynasty Business Park, A-Wing, Andheri Kurla
Road, Andheri (East), Mumbai
67 29/Misc/3/201 M/s. 3 M India Limited, Plot Nos. 48-51, 1. Tissue Adhesive for animal use Regualted 5/23/2012
2-DC(13) Electronics City, Hosur Road, Bangalore-560100
68 29/Misc/3/201 M/s. Delhi Ey Zone Pvt. Ltd., D-114, (G.F.), Lajpat 1. Ophthalmic Infusion/Aspiration Cannulas Used for Regualted 5/30/2012
2-DC(59) Nagar-I, New Delhi-110024 injection/aspiration
of fluid of gas
during eye
surgery
69 29/Misc/3/201 M/s. Pall India Pvt. Ltd., Sumer Plaza, CTS 419, 1. Platelet Therapy Kit use with autologous animal blood Intended for the Regualted 5/30/2012
2-DC(62) Marol Maroshi Road, Andheri (East), Mumbai- preparation
400059 of a platelet
concentrate form
canine whole blood
(C-PET)
or equine whole
blood (E-PET)70 29/Misc/3/201 M/s. Quantum Biological Pvt. Ltd., Block-A, 1. Vaccum Blood collection tubes without needle Used for routine Regulated 6/12/2013
2-DC(69) 36/37, Shrivasan Nagar Main Road, Perungudi, collection of
Chennai-600096 venous blood
71 29/Misc/3/201 M/s. Corions India Private Limited, No. 5, Sri 1. Orthopaedics External Fixaion Products Used in infected Not Regulated 6/12/2013
2-DC(68) Krishna Nagar Annexe, Maaduravoyal, Chennai- non-unions of
600095 fracures which
needs correction
and for the bone
deformities and
bone lengthening
procedures
72 29/Misc/3/201 M/s. Juno Pharma, 3rd Floor, Harith Arcade, D. 1. Co- Flex Unna Boot Kit with calamine and cohesive bandage Designed to treat Regulated 6/12/2012
2-DC(77) No. 3- 100/2/B, Survey No. 277, Nizampet Road, venous leg ulcers,
Hyderabad-500090 and diabetics foor
ulcer, traumatic
wounds, chronic
wounds, pressure
ulcer etc
73 29/Misc/3/201 M/s. Juno Pharma, 3rd Floor, Harith Arcade, D. 1. T- Ring Digital Tourniquet Used for wound Not Regulated 6/12/2012
2-DC(74) No. 3- 100/2/B, Survey No. 277, Nizampet Road, exploration for
Hyderabad-500090 foreign bodies
74 29/Misc/3/201 M/s. Juno Pharma, 3rd Floor, Harith Arcade, D. 1. Manta Forensics sexual assault Kits (Easi Swab Store) Used for collection Not Regulated 6/12/2012
2-DC(72) No. 3- 100/2/B, Survey No. 277, Nizampet Road, of genital and oral
Hyderabad-500090 swabs from sexual
assault victiom's
body parts
75 29/Misc/3/201 M/s. Innvolution Med Systems, 109-110, First 1. Yelloport Plus Laproscopic Port System Not Regulated 6/12/2012
2-DC(82) Floor, Roots Tower, Laxmi Nagar, District Center,
New Delhi-110092
76 29/Misc/3/201 M/s. Maxlige, New No. 56, Old No. 45/62, 2nd 1. Tubing Set for Hemodialysis Regulated 6/12/2012
2-DC(79) Main, Gabbbvipuram Extension, Bangalore-
560019
77 29/Misc/3/201 M/s. Kanam Latex Industies Private Limited, 1. Sugical Sterile Gloves/ Non Sterile Surigcal Gloves Not Regulated 7/4/2012
2-DC(103) Ooppoottil Building, K.K. Road, Kottayam-686001
78 29/Misc/3/201 M/s. Juno Pharma, 3rd Floor, Harith Arcade, D. 1. Allay Menstrual Pain Patches Use for relief of Regulated 7/4/2012
2-DC(71) No. 3- 100/2/B, Survey No. 277, Nizampet Road, menstraual
Hyderabad-500090 pain79 29/Misc/3/201 M/s. Juno Pharma, 3rd Floor, Harith Arcade, D. 1. Manta Forensics - DNA Profillling Kits consists of Adhesive Used for taking Regulated 7/4/2012
2-DC(73) No. 3- 100/2/B, Survey No. 277, Nizampet Road, bandages and Alcohol Pad DNA samples
Hyderabad-500090
80 29/Misc/3/201 M/s. Greiner Bio - One (India) Pvt. Ltd., The 1. Vacuum Blood Collection System (Vacuumised Blood Tub Holder and Not Regulated 7/11/2012
2-DC(92) corenthum, 2111, Tower-A, Plot No. A/41, Sector Collection Tube, Multisample Needle, Tube Holder) Vacuum
692, Noida-201301 bube are
Multi sample Regulated
Needle
(Disposable)
81 29/Misc/3/201 M/s. Metacure Limited, 22, Victoria Street, 1. Optimizer III A Cardiac Contractility modulation system Not Regulated 7/11/2012
2-DC(99) Hamilton HM 12, Bermuda
82 29/Misc/3/201 M/s. Metacure Limited, 22, Victoria Street, 1. Diamond (Tantalus) System Not Regulated 7/11/2012
2-DC(93) Hamilton HM 12, Bermuda
83 29/Misc/3/201 M/s. B. Braun Medical Indian Pvt. Ltd., II Floor, 1. Ecoflec Connect Not Regulated 7/11/2012
2-DC(80) 23-A, Shivji Marg, Najafgarh Road, New Delhi-
110015
84 29/Misc/3/201 M/s. Adroit Biomed Ltd, 2nd Floor, A-Wing, 1. respiR8 Monitor Not Regulated 7/11/2012
2-DC(88) Balsmruti, Murar Road, Mulund (W), Mumbai-
400080
85 29/Misc/3/201 M/s. Dentsply India Pvt. Ltd., 121 & 128, Tower 1. Dental Gutta Percha Points Use to fill the root Not Regulated 7/11/2012
2-DC(63) A, A-41, 2nd Floor, The Corenthum, Sec-62, canal of a
Noida-201301 tooth
86 29/Misc/3/201 M/s. Harsoria Healthcare Pvt. Ltd., 110-111, Phase -1. Pressure Monitoring Line Regulated 7/11/2012
1-DC(98) IV, Udyog Vihar, Gurgaon, Haryana-122015
87 29/Misc/4/201 M/s. Becton Dickinson India Pvt. Ltd., 5th & 6th 1. Research use only (ROU) Not Regulated 7/11/2012
2-DC(41) Floor, Singnature Tower B, South City I, Guragaon-
122001, Haryana
88 29/Misc/3/201 M/s. Allwin Lifecare, 4, Damji Shamji Ind., 1. Blood Line Tubing Regulated 7/11/2012
2-DC(102) Complex Off, M.C. Road, Andheri (East), Mumbai-
400 093
89 29/Misc/3/201 M/s. Totipotent Scientific Product Pvt. Ltd., 857, 1. Umbilical Cord Tissue Transport Tube Used for transport Not Regulated 7/11/2012
2-DC(78) Udyog Vihar, Phase-V, Gurgoan-122016
90 29/Misc/3/201 M/s. Neo Medisurge, M-210, 3rd Floor, Street No. 1. Endoscopy accessories- guidewire, papillotomes, stone Regulated 7/11/2012
2-DC(66) 13, Shastri Nagar, New Delhi-110034 extension balloon, stone extraction basket, lithotripter,
Polypectomy snare
91 29/Misc/3/201 M/s. Fresenius Medical Care India Pvt. Ltd., 11th 1. Puristeril 340 & Citrasteril are disinfectants Use for the Regulated 7/11/2013
2-DC(87) Floor, Front Wing, Gopal Dass Bhawan, 28, disinfection of
Barakhamba Road, New Delhi-110001 Hemodialysis
machine92 29/Misc/3/201 M/s. BL Lifesciences Pvt. Ltd., A-245, Okhla 1. Pressure Monitoring line and Pressure Monitoring Kits Regulated 7/11/2012
1-DC(90) Industiral Area, Phase-I, New Delhi-110020
2. Cardioplegia, vessel loop, toruniquet kit and Mister Blower Not Regulated 7/11/2012
93 29/Misc/3/201 M/s. Wipro GE Healthcare,No. 4, Kadugodi 1. IV Fluid/Blood Warming system Enflow warmer and Not Regulated 7/16/2012
2-DC(70) Industrial Area, Bangalore-560067 the enflow
controller- Used to
generated
temperature
Enflow disposable Regulated 7/16/2012
cartridge
with or without
extension
set- used to
connects to the
IV Extension Set
or any
infusion set
94 29/Misc/3/201 M/s. Juno Pharma, 3rd Floor, Harith Arcade, D. 1. Co-Flex (Bandage) Used for hoding Not Regulated 7/16/2012
2-DC(75) No. 3- 100/2/B, Survey No. 277, Nizampet Road, IV's and tubes
Hyderabad-500090
95 29/Misc/3/201 M/s. Johnson & Johnson Ltd, 30, Forjett Street, 1. Inroducer Sheath only to protect and Not Regulated 7/20/2012
2-DC(84) Mumbai-400036 ensure smooth
passage of coils
96 31-81- M/s. Cochlear Medical Device Company India Pvt. 1. CP802 sound processor Not Regulated 7/31/2012
MD/2006-DC Ltd., Ground Floor, Platina Builidng, Plot No. C
(Re-Reg 2009) 59, G Block, Bandra Kurla Complex, Mumbai-
400051
97 29/Misc/3/201 M/s. Edvego Technologies, No. 41, 2nd Floor, 14th 1. Tubing set for Hemodialysis Regulated 8/1/2012
2-DC(96) Cross, 18th Main, Padmanabha Nagar, Bangalore-
560070
98 29/Misc/3/201 M/s. Stericat Gutstrings (P) Ltd. 169, Sector-4, 1. Non sterile Sutute Thread Regulated 8/1/2012
2-DC(110) IMT Manesar, Gurgaon, Haryan-122050
99 29/Misc/3/201 M/s. Multi Meidcs, Plot No. 28, HPSIDC Phase 3, 1. Medical device (Bare Metal Stent) Regulated 8/8/2012
2-DC(113) Baddi, Distt. Solan-173205 (H.P)
100 29/Misc/3/201 M/s. Zenotech Laboratories Ltd, Survey No. 250- 1. Htpak® Barrels (without needles), Plunger rod and Stoppers Not Regulated 9/3/2012
2-DC(129) 252, Turkapally Village, Shameerpet Mandal RR
Disrict 500078 A.P India101 29/Misc/3/201 M/s. Clairvoyance Consulting, Flat No. 801, 8th 1. Mefix 1.Used for fixation Not Regulated 9/7/2012
2-DC(116) Floor, Indra Prakash Building, 21 Barakhamba 2. Tubifast of catheter
Road, New Delhi-110001 3. Tubigrip 2. Used for holding
4. Brevet dressing securely in
place without the
need of tapes
3. Used for
pressure dressing
4. Used for prevent
the formation of
Deep Vein
Thrombosis (DVT)
102 29/Misc/3/201 M/s. Canary Impex, 221, 2nd Floor, Rajhans 1. Disposable Hemorrhoids Stapler Regulated 9/7/2012
2-DC(123) Shopping Center, Nr. Baroda Pristage, Vrachha
Road, Surat-06
103 29/Misc/3/201 M/s. Semler Research Center Privated Limited, 1. Magnetic Resonance- Guide High Intensity Focused Used in MR Not Regulated 9/7/2012
2-DC(120) 75A, 15tH Cross, I Phase, J.P Nagar, Bangalore-78 Ultrasound for Pallition of painful Skeletal Metastases System Provide
images to plan the
therapy
and to guide and
monitor
the thermal ablation
with termal
imaging during the
treatment104 29/Misc/3/202- M/s. L & T Integrated Engineering Services, Larsen 1. Clotalyst Kit with GPS III Separatory System Is a blood Regulated 9/7/2012
DC(118) & Toubro limited, Bellary Road, Byatarayanapura, fractioning Devices
Bangalore-560092 System, Used in
prepration of
autologous serum
that is to be mixed
with auto-graft or
allograft for bone
graft handling prior
to the application to
the orthopaedic
surigcal site and the
kit contains the
components like-
Syringes, Needle
and Needle set,
Tourniquet, alcohol
swab pad, Tube,
Bottle of ACD-A
105 29/Misc/3/201 M/s. Emcure Pharmaceuticals Limited T-184, 1. Hypak® Barrels (without needlse), plunger rod and Stoppers Not Regulated 9/7/2012
2-DC(130) M.I.D.C, Bhosari, Pune- 4110026
106 29/Misc/3/201 M/s. Gennova Biopharmaceuticals Limited T-184, 1. Hypak® Barrels (without needlse), plunger rod and Stoppers Not Regulated 9/7/2012
2-DC(126) M.I.D.C, Bhosari, Pune-411026
107 29/Misc/3/201 M/s. Global Prosumers Associates, Flat No. 11, 1. Quantum Resonance Magnetic Analyzer (QRA) To collect the weak Not Regulated 9/7/2012
2-DC(124) Navbharat Appartment, 7/137, Swarup Nagar, magnetic
Kanpur-208 002 field of human cells
for scientific
analysis
108 29/Misc/3/201 M/s. S.M Health Care Products Pvt. Ltd., 14/95, 1. Semi-finsihed, Non Sterile Products-Catheters/ and sizes, Not Regulated 9/7/2012
2-DC(81) 1st Floor, Geeta Colony, Delhi-110031 Biopsy products/ Needlses in different types, Guide-wire and
Packaging Components in different shapes and sizes, Tubing
and Tubing Contractor and accessories in different materials
and sizes etc
109 29/Misc/4/201 M/s. Totipotent Scientific Product Pvt. Ltd., 857, 1. Umbilical Cord Tissue Transport Tube (Tube with buffered Not Regulated 9/25/2012
2-DC(58) Udyog Vihar, Phase-V, Gurgoan-122016 saline only no umblical cord)
110 29/Misc/3/202- M/s. Advance Hydrau, Components Pvt. Ltd., 1. Bandages- Soft-1 & UNI Bandaes Used for the stop Regulated 9/25/2012
DC(38) Khasra No. 86/24, Hiran Kundna More, Near the bleeding
Ganga International School, Ghevra, New Delhli- & also to protect
110041 the wounds.111 29/Misc/3/201 M/s. Neutron Sugicals Pvt. Ltd. 306, Yusug Bldg, 1. Ostomy Bags For collection of Not Regulated 9/19/2012
2-DC(128) 50/51, V. Nariman Road, Near Akbarally's Fort, wastes form
Mumbai-4000001 sugical diverted
biological system
(Colon, ileum,
urinary) and certain
of stoma
112 29/Misc/3/201 M/s. India Medtronic Pvt. Ltd., A-16, Mohan Co- 1. Centrifugal Blood Pump Not Regulated 9/19/2012
2-DC(115) operative Industiral Estate Ltd, Ground Floor,
Mathura Road, New Delhi-110044
2. Oxygenator Not Regulated
113 29/Misc/3/201 M/s. Envy International Private Limited, NH-2, 1. Collagen Based Medifil granules & Skin temp Sheets Regulated 9/19/2012
2-DC(119) 2nd Floor, C-Block, Community Centre, Naraina
Vihar, New Delhi-110028
114 29/Misc/3/201 M/s. Cyro Healhcare Pvt. Ltd., C-6, Greater 1. NUV ADERM Liquid Bandage 1. Use to cover Regulated 11/23/2012
2-DC(132) Kailash-1, New Delhi-110002 2. NUV AVET Animal Healthcare Liquid Bandage intact skin or minor
cuts, scrapes, burns
and irritations of
the skin, to help
keep them clean
and dry and help to
protect them from
injection
2. Used on small
and large animals,
includidng dogs,
cats, horses,
hotsports, burns or
other irritations of
the skin to help
keep then clean and
dry, and help
protect them form
infection
115 29/Misc/3/201 M/s. Schulke India Pvt. Ltd., A-24/9, Mohan Co- 1. GIGAZYME Cleaner for manual Not Regulated 12/11/2012
2-DC(144) operative Ind. Est. Mathura Road, New Delhi- and automatic
110044 cleaning or
Endoscopes and
Sugical
instruments.116 29/Misc/3/201 M/s. Emergo India Consulting Private Limited, 8/1, 1. Vedera KXS System Which delivers a Not Regulated 12/11/2012
2-DC(147) First Floor, Vasavi Colony Kakguda, Near Picket, short burst energy
Secunderabad- 500009 (A.P) in a predetermined
pattern onto human
cornea
117 29/Misc/3/201 M/s. Accredited Consultants Pvt. Ltd., D-29, First 1. Ostomy Bags For collection of Not Regulated 12/11/2012
2-DC(85) Floor, Acharya Niketan, Mayor Vihar Phase-1, wastes form
Delhi-110091 sugical diverted
biological system
(Colon, ileum,
urinary) and certain
of stoma
118 29/Misc/3/201 M/s. Lifewatch Technologies Ltd., 2 Perkeris St. 1. Lifewatch V Not Regulated 12/13/2012
2-DC(108) P.O. Box-527, Rehovot-76100, Israel
2. Glucose test strips Regulated
119 29/Misc/3/201 M/s. BioAide Technologies Pvt. Ltd., Flat No. 207, 1. Debrisoft Used for Regulated 12/13/2012
2-DC(152) 2nd Floor, Savitri Cinema Complex, Greater debridgement of
Kailash Part-11, New Delhi-110048 acute or chronic
wounds of all
origin
120 29/Misc/3/201 M/s. Care Group India, A Unit of Polymer 1.Corneal inlay (having no power) Used for improving Not Regulated 12/13/2012
2-DC(149) Technologies INTL, Block no 310 Village Sim of the depth of Focus
Dabhasa, Ta Padra, Dist Vadodara-391440 by cutting the
unnecessary light
entering in the eye
121 29/Misc/3/201 M/s. Cambindia Biotech Kits (Pvt.) Ltd., Ground 1. Evacuated Blood Collection Container/ Tubes Used to collect, Not Regulated 12/31/2012
2-DC(167) Floor, H. No. 817(A), Gurukripa Nagar, Post. Store, Transport
Saravali, Kon Village, Tal Bhiwandi, Dist Thane and process the
Tal Bhiwand (Thane Zoens) 421311 blood to
laboratories for
blood testing
(investigation)2013 Database
S. NO. File . No. Name of the Company and Address Product Name Intended Use Regulatory Status Date of Issue
29/Misc/3/2012-
1 M/s. Labtech Disposablses Not Regulated 1/3/2013
DC(175)
406-Shefali Shopping Centre, Paldi Char Rasta, Ahmedabad-6 1. Blood Collection Tubes
1. ImaCor ZuraTM Imaging
29/Misc/3/2012- System and ImaCor Zura-
2 Not Regulated 1/8/2013
DC(154) M/s. Imacor Inc, 839, Stewart EvoTM Imaging System
avenue Suite 3, Garden City, NY 11530-4863 With Claritee Probe
29/Misc/3/2012- M/s. Bear Medic Corporation, 1. Disposable Micro
3 Not Regulated 1/8/2013
DC(50) Yushima 2-31-24, Bunkyok-Ku, Tokyo 113-0034 Japan Vasular Clip
M/s. T Bose,
Col Dir AFMS (Prov)
29/Misc/3/2012-
4 Post Contract Management Cell, Raksha Mantrayala, Karyala 1. Endo Path Tristar Surgical Not Regulated 1/8/2013
DC(158)
Mahinideshak, Sashastra Sena Chikitsa Sewa, M Block New Trocar 5 MM and 10/11 with
Delhi-110001 Safety Shield
M/s. Juno Pharma, 3rd Floor,
29/Misc/3/2012- Haritha Arcade, D. No. 3-100/2/B,
5 Not Regulated 1/8/2013
DC(76) Survey No. 277, Nizampet Road,
Hyderabad-500090 1. Manta Forensics Unidentified
29/Misc/3/2012- M/s. Chadha & Co., Advocates & Legal Consultants, S-327, 1. Prevena™ Incision
6 Regulated 2/19/2013
DC(151) Greater Kailash-II, New Delhi-110048 Management System
M/s. Teriage Healthcare Technologies
29/Misc/3/2013- Flat No.. 17, Aashirwad Apartments,
7 Regulated 2/19/2013
DC(08) Property No. 886-C/8, 1. Comprehensive Negative
Mehrauli, New Delhi-110030 Pressure Wound Therapy Dressing Pack
M/s. Cambindia Biotech Kits
29/Misc/3/2013-
8 (Pvt.) Ltd., A-208, Partik Industrial Estate, Mulund-Goregoan Regulated 2/26/2013
DC(15)
Lind Road, Mulund(W) Mumbai-400078, Maharashtra
1. Luer Adaptor
M/s. Emergo (India) Consulting
29/Misc/3/2013-
9 Pvt. Ltd., 8/1, Vasavi Colony, kaka Guda, Secunderabad, 1.Pharmajet Startis Needle free injection Not Regulated 2/26/2013
DC(16)
Andhra Pradesh-500009 System
M/s. Gambro India Pvt. Ltd.,
29/Misc/3/2013-
10 No. 5, Sixth Floor, Crown Court No. 34/New no. 128, Regulated 3/6/2013
DC(25)
Cathedral Road Chennai-600086 1. Oxiris Set
29/Misc/3/2013- M/s. Bombay Dental & Surgical Pvt. Ltd.,
11 Regulated 3/6/2013
DC(23) D-104/105, Sitladevi C.H.S Ltd, D.N Nagar, Opp Indian Oil 1. Surface Cleaner & Intermediate Level
Nagar, New Link Road, Andheri (W), Mumbai-400043 Distinfectant29/Misc/3/2013- M/s. Stryker Indai Pvt. Ltd., C-5, SDA, Commercial Complex
12 Regulated 3/6/2013
DC(18) New Delhi-110016 1. Transcend Guidewires
29/Misc/3/2013- M/s. Bell Surigcal, Unit No. 68, Part A, Municipal Industrial 1. Casting Tape intended to fix broken or
13 Regulated 3/6/2013
DC(21) Estate, Gandhi Nagar, Worlil, Mumbai-400018 dislocated bone
29/Misc/3/2013-
14 M/s. Covidien Healthcare India Pvt. Ltd., 10th Floor, Building Not Regulated 4/2/2013
DC(26)
No. 9 B, DLF Cyber City, Phase-3, Gurgaon-122002, Haryana 1. MyOcclude
29/Misc/3/2013- M/s. Abbott Healthcare Pvt. Ltd., 4, Corporate Park, Sion
15 Regulated 4/5/2013
DC(34) Trombay Road, Mumbai-400071, India 1. Acetium Capsule
M/s. Anamed Instruments Pvt. Ltd., P.O. Box No: 8336,
29/Misc/3/2012-
16 Ujagar Industrial Estate, W.T.P. Road, Deonar, Mumbai- 1. Intracranial Pressure (ICP) monitoring Regulated 4/5/2013
DC(188)
400088 and drainage system
Dr. A B Bhamare, Dy. Dean (CPD) Municipal Corporation of
29/Misc/3/2013- Greater Mumbai, Central Purchase Department, Medicine
17 Not Regulated 4/5/2013
DC(11) Tender Section, 566, N.M. Joshi Marg, Byculla, Mumbai-
110002 1. Sutures
29/Misc/3/2013- M/s. Delhi Eye Zone Pvt. Ltd., D-114, G.F, Lajpat Nagar-1,
18 Not Regulated 4/9/2013
DC(17) New Delhi-110024 1. Tiggerfish (the Sensor)
29/Misc/3/2013- M/s. Allied Healthcare India 3, Arumugam Street, Anna Salai, 1. Enteral Feeding set for giving nutrition
19 Regulated 4/9/2013
DC(52) Chennai-600002 for patients
29/Misc/3/2013- M/s. Eli Lily and Company (India) Pvt. Ltd., Plot No. 92,
20 Not Regulated 4/23/2013
DC(36) Sector-32, Gurgaon-122001 Haryana 1. HumaPen Savvio pen Injector
29/Misc/3/2013- M/s. Sterile Medical Apps. Inc., A-140/1, Okhla Industrial
21 Regulated 4/23/2013
DC(10) Area, Phase-II, New Delhi-20 1. Surgical Dressing
29/Misc/3/2013- M/s. Bappa Morya Enterprises, 4, Ganga Joyti C.H.S, Bangur
22 Not Regulated 4/23/2013
DC(58) Nagar, Goregaon (W), Mumbai-400090 1. Breastlight (Blood vessels in breast)
29/Misc/3/2012- M/s. Guerbet India Liaison Office 422, Level 4, Augusta Point
23 Regulated 4/23/2013
DC(01) Sector 53, Golf Course Road, Gurgaon-122002 1. Lipiodal
M/s. Emergo (India) Consulting
29/Misc/3/2013-
24 Pvt. Ltd., 8/1, Vasavi Colony, kaka Guda, Secunderabad, Not Regulated 4/29/2013
DC(53)
Andhra Pradesh-500009 1. Gutta Percha
29/Misc/3/2013- M/s. Litejoy International Private Limited, S-289, Ground
25 Not Regulated 4/30/2013
DC(62) Floor, Greater Kailash-I, New Delhi-110048 1. Disposable Electronic Cigarettes
29/Misc/3/2013- M/s. Intas Medi Devices Limited, 9th Floor, Premier House-1,
26 Regulated 4/30/2013
DC(60) S.G Highway, Bodakdev Ahmedabad-380054 1. Guidewires
29/Misc/3/2013-
27 Regulated 4/30/2013
DC(28) M/s. Ecobase, Lieserhoferstraβe 7-9851. Lieserbrucka Austia 1. Activated Zeolite
29/Misc/3/2013- M/s. GlaxoSmithKline Asia Pvt. Ltd., Plot No. 67, Sector-32,
28 Not Regulated 4/30/2013
DC(55) Gurgaon-122001, Hayana 1. Denture Cleansing Cream
29/Misc/3/2013- M/s. GlaxoSmithKline Asia Pvt. Ltd., Plot No. 67, Sector-32,
29 Regulated 4/30/2013
DC(55) Gurgaon-122001, Hayana 1. Denture Cleansing Tablets
29/Misc/3/2013- 1. Health Worker Bag and Vaccum
30 Regulated 5/1/2013
DC(64) M/s. Terra India, 5/20, Punjabi Bagh Extn. New Delhi-110026 ExtractorShri A. Ranga Rao, Principal Co-Ordinator (ASHA), H. No. 8-
29/Misc/3/2013-
31 2-595/2/B, Road No. 10, Banjara Hills, Hyderabad-500034, Not Regulated 5/1/2013
DC(57)
Andhra Pradesh 1. Re-Usage of Singale Use Devices (SUD)
M/s. India Medtronic Pvt. Ltd., A-16, Mohan Co-operative
29/Misc/3/2013-
32 Industrial Estate Ltd., Ground Floor, Mathura Road, New Regulated 5/8/2013
DC(54)
Delhi-110044 1. Merocel Hemox Sponges
M/s. Meril Endosurgery Pvt. Ltd., Survey No. 135/2/B,
29/Misc/3/2013-
33 Bilakhia House Muktanand Marg, Chala, Vapi-396191, Regulated 5/9/2013
DC(50)
Gujarat 1. Cartdridge/Pins
M/s. Meril Endosurgery Pvt. Ltd., Survey No. 135/2/B,
29/Misc/3/2013-
34 Bilakhia House Muktanand Marg, Chala, Vapi-396191, Not Regulated 5/9/2013
DC(50)
Gujarat 1. Staplers (Instrument)
1. SB Knife (Monopolar ESD knife)
29/Misc/3/2012-
35 M/s. Sibre Systems and Services Pvt. Ltd., 2E/12, 4th Floor, 2. Flexible overtube (Guide tube for passing Regulated 5/9/2013
DC(166)
Jhandewalan Extn. New Delhi-110055 the pharynx)
29/Misc/3/2012- M/s. Sibre Systems and Services Pvt. Ltd., 2E/12, 4th Floor, 1. Tentacles
36 Not Regulated 5/9/2013
DC(166) Jhandewalan Extn. New Delhi-110055 2. SB Disposable Hood for ESD Products
29/Misc/3/2013- M/s. Vipro Lifescinces, 402-403, Sarthik-II, Oppt. Rajpath
37 Regulated 5/21/2013
DC(68) Club, S.G Road, Ahmedabad 1. Condoms
29/Misc/3/2013- M/s. Stryker Indai Pvt. Ltd., C-5, SDA, Commercial Complex
38 Regulated 5/21/2013
DC(39) New Delhi-110016 1.Trevo Retrievers
29/Misc/3/2013-
39 M/s. Vinvish Technologies Pvt. Ltd., C-16, Level C, Not Regulated 5/21/2013
DC(74)
Thejaswini Building, Technopark, Trivandrum, Kerala-695581 1.Photo Dynamic Therapy Laser system
29/Misc/3/2013- M/s. Zest Othocare Pvt. Ltd., 48, 1st Floor, Sardar Nagar
40 Regulated 6/3/2013
DC(75) Society, Sumul Diary Road, Surat-395008 1. CAST O LITE
29/Misc/3/2012- M/s. Taneermedico A/S DTU Sciences Park, Agern Alle 3, DK-
41 Regulated 6/4/2013
DC(170) 2970 Horsholm, Denmark 1. Asonor
M/s. Safetec Healthcare and Hygiene Pvt. Ltd., Block No. 1,
29/Misc/3/2012-
42 Plot No. A-13, Chakan MIDC, Phase-IV, Village-Nighoje, Tal: Regulated 6/4/2013
DC(173)
Khed, Dist-Pune-410501 1. Disinfectants
29/Misc/3/2013- M/s. Intech Safety Pvt. Ltd., 83 & 84 Chanditala Main Road, 1. Self Generating Oxygen Type Chemical
43 Regulated 6/4/2013
DC(138) Kolkata-700053 Self Rescuer (SCSR)
29/Misc/3/2013- M/s. South India Surgical Co. Ltd., #117/65, Wallajah Road,
44 Not Regulated 6/4/2013
DC(05) Chennai-600002 1. Capsule Endoscope
29/Misc/3/2012- M/s. B. Braun Medical (India) Pvt. Ltd., III Floor, 23-A,
45 Regulated 6/4/2013
DC(153) Shivaji Marg, Najafgarh Road New Delhli-110015 1. Sol-Cart B
M/s. Emergo (India) Consulting
29/Misc/3/2012-
46 Pvt. Ltd., 8/1, Vasavi Colony, kaka Guda, Secunderabad, Regulated 6/4/2013
DC(117)
Andhra Pradesh-500009 1. Mix2Vial Transfer Devices
29/Misc/3/2012- M/s. Kamuk Life, 01 Darshan Enclave, Bopal-Ghuma Road,
47 Not Regulated 6/11/2013
DC(176) Ghuma-380058 1. Magical Granule Patch
M/s. Silverline Worldwide Logistics Rex Chamber, Office No.
29/Misc/3/2012-
48 310/311, 3rd Floor, Walchand Hirachand Marg, Near Jahaz Regulated 6/14/2013
DC(85)
Bhavan, Ballard Estate, Mumabai-400001 1. Othopedi Casting Tapes29/Misc/3/2012- M/s. Greatlinx Impex Pvt. Ltd., 104, Vanchinad Building,
49 Regulated 6/18/2013
DC(92) Kaloor, Cochin, Kerala, 682017 1. Silicone Gel Ointment and Silicone Sheet
29/Misc/3/2013-
50 Not Regulated 7/3/2013
DC(89) M/s. Benson Medical Equipments (India) Pvt. Ltd., New Delhi 1. Medical Equipment's
M/s. Q Pharm Cousulting India
29/Misc/3/2013-
51 # 26, Hi-Rise Colony, Phase-II, 1. Personal Lubricant, Regulated 7/9/2013
DC(101)
Nizampet, Hyderabad-500090 "PROBE"
29/Misc/3/2012- M/s. HLL Lifecare Limited, A Govt of India Enterprises, HLL
52 Not Regulated 7/9/2013
DC(172) Bhavan, Poojappura, Thiruvananthapuram-695012 1. Empty PVC Bags
M/s. Gambro India Pvt. Ltd.,
29/Misc/3/2012-
53 No. 5, Sixth Floor, Crown Court No. 34/New no. 128, Regulated 7/15/2013
DC(97)
Cathedral Road Chennai-600086 1. Bicart
M/s. Orchid India Medisolutions Private Limited, Flat No.
29/Misc/3/2013-
54 305, 3rd Floor, Shroff Soleno Solitair, Surey No. 12/2/1 & Regulated 7/19/2013
DC(110)
12/2/2, Mhalunge, Pune-411045 1. Othopedic Implants
M/s. Nextgen Solution Pvt. Ltd., E-501, Sunflower Society,
29/Misc/3/2013-
55 Gundecha Colony, Thakur Village, Kandivali (E), Mumbai- 1. Double Pump RF Day Cassette & Double Not Regulated 7/19/2013
DC(48)
400101 Pump RF Patients Cassette
29/Misc/3/2013- M/s. Sterimed Inc., Peringannur, Peringode, Pattambi-679535
56 Not Regulated 7/23/2013
DC(111) Palakkad, Kerela, India 1. Sterilization monitoring
12-01/13-DC (Pt- Mr. Manish Agarwal, Lt. Col, JDMS (Procurement) Integrated
57 Regulated 8/6/2013
35) HQ of MOD (Army), Adjunct Gernal's Branch, Dte. Gen. of 1. Haemostatic Bandages/Gauze with
Medical Services (Army) 'L' Block, New Delhi Chitosan
1. Rehabilitation Aids (Back Supports,
Cervical Aids, Cervical Pillows, Wrist and
29/Misc/3/2012-
58 Mr. Pramod Kumar, Foreign Trade Development Officer, Elbow Support, Weight Cuff, Orthopaedic Not Regulated 8/6/2013
DC(141)
Ministry of Commerace and Industry, Directorate Gernal of Stockinette, Knee Calf Supports, Ankle
Foreign Trade Udyog Bhawan, New Delhi Othosis, Fractute Aids, Pelvic Traction Kit
M/s. Star Radiance Medical Devices Training Aids No. 5&6,
29/Misc/3/2013-
59 G-2, Crystal Glade, Kothandan Street, Devendran Nagar, Regulated 8/6/2013
DC(65)
Kundrathur, Chennai-600059 1. Indigo Carmine
1. Heart Positioners (Starfish and Urchin),
Centrifugal Blood Pump (Bio-Pump),
29/Misc/3/2013-
60 M/s. India Medtronic Pvt. Ltd., A-16, Mohan Co-operative Arterial Filters (Affinity Arterial Filters), Not Regulated 8/6/2013
DC(59)
Industrial Estate Ltd., Ground Floor, Mathura Road, New Cardioplegia Delivery System (Myotherm
Delhi-110044 XP) and Tissue Stabilizer (Octopus)
M/s. Kimberlyl-Clark Hygiene Products Pvt. Ltd., Survey No. 1. Kim Vent Yankuer
29/Misc/3/2012-
61 279, Raisoni Industial Park, Village Mann, Taluka, Mulshi, 2.Kim Vent Suction Handle Not Regulated 8/6/2013
DC(91)
Pune-411057 3.Kim Vent Oral Care Suction Tooth Brush
29/Misc/3/2013-
62 M/s. Covidien Healthcare India Pvt. Ltd., 10th Floor, Building Not Regulated 8/6/2013
DC(87)
No. 9 B, DLF Cyber City, Phase-3, Gurgaon-122002, Haryana 1. Surgisleeve29/Misc/3/2013-
63 M/s. Becton Dickinson India Pvt. Ltd., 5th Floor, Signature Regulated 8/5/2013
DC(116)
Tower B, South City I, Gurgaon-12201, Haryana, India 1. BD Sentry Safety Lancet
29/Misc/3/2013- M/s. India Sani Chem C-28, Pushpanjali Farms, Bijwasan,
64 Not Regulated 8/12/2013
DC(127) New Delhi-110061 1. Echo-Clean PRO Purge
29/Misc/3/2013-
65 M/s. Mtex India Private Limited A-26/4, Mohan Co-operative 1. X Cura Cast Regulated 8/27/2013
DC(132)
Industrial Estate, Mathura Road, New Delhi-110044 2. X Cura Splint
29/Misc/3/2013- M/s. Zest Othocare Pvt. Ltd., 48, 1st Floor, Sardar Nagar
66 Regulated 9/3/2013
DC(75) Society, Sumul Diary Road, Surat-395008 1. ALTOCAST
1.. Opthalmic, ENT, Dental Microsurgical
29/Misc/3/2013- M/s. Susruta Instruments Pvt. Ltd., Plot No. 87/3/B-1, First Blades and Knives, Opthalmic Instruments
67 Not Regulated 9/3/2013
DC(133) Floor, Opp. Pushpak Estate, Phase 1, G.I.D.C. Vatva, Including Probes, Forceps, Scissors,
Ahmedabad-382445 Speculum, Needle Holder and Opthalmic
29/Misc/3/2013-
68 M/s. Becton Dickinson India Pvt. Ltd., 5th Floor, Signature 1. BD Phaseal (Closed System Drug Regulated 9/4/2013
DC(29)
Tower B, South City I, Gurgaon-12201, Haryana, India Transfer Device)
M/s. Meril Endosurgery Pvt. Ltd., Survey No. 135/2/B,
29/Misc/3/2013-
69 Bilakhia House Muktanand Marg, Chala, Vapi-396191, Not Regulated 9/4/2013
DC(93)
Gujarat 1. Surgical Trocar
Use for personal
29/Misc/3/2013-
70 M/s. Nanz Med Sciences Pharma (P) Ltd., Rampur Ghat, hand hygien to Regulated 9/10/2013
DC(113)
Paonta Sahib, District Sirmour, H.P 1. Isopropyl Alcohol/Pre Injection Swabs help or prevent the
M/s. Rekha Production Pvt. Ltd., & SGS Sciences, Aditya
29/Misc/3/2013-
71 Enclave, Flat #G11, Kanchna Junga 'D' Block, Ameerpet, Not Regulated 9/10/2013
DC(138)
Hyderabad. 1. Anti-raditation Chip
Sh. Sudhir Kumar, Under Secretary (Drugs), (DFQC Section),
29/Misc/3/2013-
72 Ministry of Health & Family Welfare, Nirman Bhavan,New Not Regulated 9/25/2013
DC(142)
Delhi-110108 1. X-Ray equipment/ X-Ray (S)
1. Sterigen Disinfectant Generation System Not Regulated
Super Oxidized solution/Sterigen
solution containing salts like
29/Misc/3/2013-
73 Sodium Hypochlorite, Hypochlorous Used as a 10/14/2013
DC(136) Regulated
acid, Hygreogen peroxide, Ozone, disinfectant
M/s. Faith Innovation, E-107, Lajpat Nagar-I, New Delhi- Cholorine dioxide, Sodium Hydroxide,
110024 Sodium Carbonate and Sodium Chloride
29/Misc/3/2013- M/s. Chitrarath, 5 Darshana Bhawan, HR/62A, Sohan Lal 1. Sureseal (Self activatin Pressure
74 Regulated 10/21/2013
DC(69) Marg, Pul Pahladpur, New Delhi-110044 Bandage)1. Correction of
misaligned
crooked teeth
2.For the molar
teeth, to support
the movement of
the front teeth
3. Used to move
the teeth along
29/Misc/3/2013- with the brackets
75 Not Regulated 10/21/2013
DC(107) and in some cases
elastics
1.Ceramic/Metallic Brackets 4. Used to stick
2.Buccal Tubes the bracket or
3. Archwire Products band to the
4. Bonding/Banding Products surface of the
5. Curing Light tooth temporaily,
6. Intraoral Product till the teeth are
M/s. 3M India Ltd., Plot No. 48-51, Electroics City, Hosur 7. Extraoral Products removed
Road, Bangalore-560100 8. Instruments. 5. To cure or
Cervitec liquid
and Gel, a
29/Misc/3/2013- ready to use
76 Regulated 10/22/2013
DC(127) M/s. Ivoclar Vivadent Marketing (India) Private Limited, 503- antibacterial
504 Raheja Plaza, 15B, Shah Industrial Estate, Off Veera mouth
Deasi Road, Andheri (w), Mumbai-400053 1. Dental Consumables rinse inhibiting
Intended for
29/Misc/3/2013-
77 M/s. Pushpanjali Medi India Pvt. Ltd., Gandhi House, 16, preventive Regulated 10/22/2013
DC(156)
Ganesh Chandra Avenue, 5th Floor, Kolkata-700013 1. Cerederm Silicone Dressing treatment
M/s. PAT Pharma Consultant Consultant Pvt. Ltd., Unit No.
29/Misc/3/2013-
78 IInd Floor, Vikas Surya Arcade, Plot No. 7, CU Block, 1. Endostim Lower Esophagal Sphincter Not Regulated 11/12/2013
DC(154)
Pitampura, Delhi-110088 Stimulation System
M/s. CellBios Healthcare and Life Sciences Pvt. Ltd., 1/7, First Intended for
29/Misc/3/2013-
79 Floor, Poonamallee High Road, Vanagaram, Chennai 600095, stroage of Regulated 11/19/2013
DC(152)
Tamilnadu 1. Freezing Bags Transfer Set Peripheral Blood
is Medical
29/Misc/3/2013- equipment which
80 Not Regulated 11/19/2013
DC(150) M/s. Incredible Group C.O.: 909 Kedar Building, Clock 1. NUTAS E-10(Non-Invasive Ultrasound utilizes high
Tower, Delhi-110007 Tumor Ablations System) intensity focused
1. Intended to
obtain the view of
29/Misc/3/2013-
81 M/s. Hospital Equipment Manufacturing Company D-313, the vocal folds Not Regulated 11/26/2013
DC(125)
Sector-63, Noida, Distt. Gautam Budh Nagar, Uttar Pradesh 1. Laryngoscope Blades and Handles and glottis
201301 2. Resuscitator 2. A device used29/Misc/3/2013- M/s. 3M India Ltd., Plot No. 48-51, Electroics City, Hosur
82 Regulated 11/26/2013
DC(112) Road, Bangalore-560100 1. IV Securement Dressings
Mr. Om Prakash, Section officer, Govt of India, Ministry of
29/Misc/3/2013-
83 Health & Family Welfare DFQC Section, Nirman Bhawan, 1. AERB (Medical X-ray equipment under Not Regulated 11/26/2013
DC(167)
New Delhi subheading of Exim code-9022
M/s. Emergo (India) Consulting
29/Misc/3/2012-
84 Pvt. Ltd., 8/1, Vasavi Colony, kaka Guda, Secunderabad, 1. Atricure Cry Module System & Articure Not Regulated 12/6/2013
DC(143)
Andhra Pradesh-500009 Abalation System
1. Bone Marrow Biopsy Needles
29/Misc/3/2013-
85 M/s. Med Evolution Devices Pvt. Ltd., New No. 7, Old No. 4, 2. Soft Tissue Biopsy Needles Regulated 12/11/2013
DC(176)
I Cross Steet, Shastri Nagar, Adyar, Chennai-600020 3. Cytohistological Biopsy Needles
29/Misc/3/2013- M/s. M.J. Medical Devices Private Limited, 706, Rajgir Sadan, Treatment of pain
86 Regulated 12/16/2013
DC(183) 7th Floor, Lami Baug, Mumbai-400022 1. Flexiseq associated with
For the Protection
29/Misc/3/2013- of minor
87 Regulated 12/27/2013
DC(171) M/s. Beiersdorf India Pvt. Ltd., Niranchal Road, Curti, Ponda, cuts and abrasion
Goa 403409 1. Kid Plaster on the skin
For fixation of
intravascular
29/Misc/3/2013-
88 devices such as IV Not Regulated 12/27/2013
DC(175)
M/s. Molnlyke Healthcare Inida Pvt. Ltd.,C-1664, AKD Catheters,
Tower, Sushant Lok-1, Guragaon 1. Mepore IV Peripheral
Used to deliver
29/Misc/3/2013- chemotherapy ot
89 Not Regulated 12/27/2013
DC(174) M/s. OnMed India Pvt. Ltd., 425/22, Shasi-Neel Apt. 7-8, cancer tumors by
T.M.V. Colony Gultekdi, Pune 411037 1. Sennex Electro-Chemotherapy Unit quick pulsating2014 Database
S.
NO. File . No. Name of the Company and Address Product Name Intended Use Regulatory Status Date of Issue
M/s. DHR Holding India Pvt. Ltd., Plot NO. Use for cleaning the cover
29/Misc/3/2013-
1 121, Phase IV, Udyog Vihar, Gurgaon glasses of the optronic Unit for HemoCure photometers and Not Regulated 1/3/2014
DC(177)
122002 1. HemoCue Cleaners analyzers
29/Misc/3/2013- M/s. Smith & Nephew Healthcare Pvt. Ltd., B-
2 Not Regulated 1/15/2014
DC(163) 508, 509, Dynasty Business Park, Andheri- Taylor Spatial Frame and JET-X Extrenal Fixator, and
Kurla Road, Andheri (E), Mumbai 400059 1. External Fixation Systems external method of skeletal Immobilization
M/s. Becton Dickinson India Pvt. Ltd., No. 1. BD Vacutainer Blood
3(M/D)/2013-
3 34 Assisi Nagar, West Thottam, Madhavram, Transfer Device (without Not Regulated 1/15/2014
DC(116)
Chennai 51 needle)
M/s. Coloplast (India) Pvt. Ltd., Khasra Nos A periwound dressing intended for filling in cavities/folds
29/Misc/3/2013-
4 44/14/2, 17 & 47/4,5,6,7 Village-Taj Nagar, 1. Coloplast Paste & Brava in the skin around the stoma and protecting skin against Regulated 1/15/2014
DC(181)
Patudi Road, District-Gurgaon Strip Paste stoma output
1. Intended for cleansing of skin exposed to urine, faeces,
29/Misc/3/2013- M/s. Coloplast (India) Pvt. Ltd., Khasra Nos urine and pus and in removing skin barries.
5 Regulated 1/15/2014
DC(164) 44/14/2, 17 & 47/4,5,6,7 Village-Taj Nagar, 1. Comfeel Cleanser 2. Intended for protection of skin against stoma output, and
Patudi Road, District-Gurgaon 2. Brava Protective Sheet for skin protection.
Which enables individuals to instaneously record their heart
29/Misc/3/2013- M/s. Occu'passion Retails Pvt. Ltd., 1-106, rhytm measurement (ECG) at a touch of their fingers with
6 Not Regulated 1/15/2014
DC(187) Road No. 3, Himgiri Enclave, Chander Vihar, 1. EPI-Mini- Mobile ECG clinical precision providing remote health monitoring
Nilothi Extension, New Delhi-41 Monitoring Device solution
M/s. Sken Healthcare Pvt. Ltd., B-1001,
29/Misc/3/2013- Growmore Towers, Plot No. 5, Sector-2, Consisting of 1 sterile disposable syringe each containing
7 Regulated 1/15/2014
DC(189) Kharghar, Navi Mumbai, Maharashtra 15 ml Birth gel individually packed in sterile packaging
410210 1. Natalis Birth Gel with vaginal catheter intended for easing vaginal birth
1. Cold Box
2. Mannual Ventose(Vaccum
Extractor)
29/Misc/3/2013- 3. Mask
8 Not Regulated 1/15/2014
DC(108) 4. Oxygen Flow Regulator
5. Vaccination Carrier
M/s. Terra India, 5/20, Punjabi Bagh Extn., 6. Comkunity Health Worker
New Delhi 110026 Kit
M/s. Progen SAA Technologies India (P) Ltd.
29/Misc/3/2013- 809, Eighth Floor, Tower-I Pearls Omaxe, 1. Disinfectants (Antiseptica
9 Regulated 1/20/2014
DC(172) Netaji Subhash Place, Pitampura, New Delhi Combi Instrument-N & Triacid-
110034 N Use for disinfection of instruments & laboratory equipment
M/s. Gnana Medical Private Limited, Old No. Use for Cardiopulmonary resuscitation and during surgery
29/Misc/3/2013-
10 16, Defence Colony, Edaduthangal, Chennai- to allow anesthetic gases and oxygen to enter into a patients Regulated 1/21/2014
DC(155)
097, Tamil Nadu 1. Gnana Laryngeal Airway lung1. Ambulatory Insulin Infusion
Pump Reservior
29/Misc/3/2013- 2. Disposable Infusion Sets for
11 Regulated 1/21/2014
DC(130) M/s. India Medtronic Pvt. Ltd., 4-16 Mohan Ambulatiry Pumps
Co-operative Industrial Estate Ltd., Ground 3. Ambulatory Insulin Infusion Use for the subcutaneous infusion of medication, including
Floor, Mathura Road, New Delhi-110044 pumps insulin from an infusion pump
1. Intended to provide optimal barrier against microbial
1. Barrier Surgical Drapes
migration and effective infection control Regulated
(Sterile)
M/s. Molnlycke Health Care India Private 2. Barrier Surgical Staff
29/Misc/3/2013-
12 Limitd C-1664, AKD, Tower, Sushant Lok-I, Clothing, 1/21/2014
DC(169)
Gurgaon 3. Barrier Supplementaries
Not Regulated
(Stand Covers, Table Covers,
Pouches, Equipment Drapes)
4. Barrier Easywarm Blanket
29/Misc/3/2013- M/s. Eucare Pharmaceuticals Private Limited, Use for separation platelets from autologous whole blood is
13 Regulated 1/21/2014
DC(147) Plot No. AC-25B, SIDCO Industrial Estate, 1. EUCAPS Concentrated available as a kit consisting of Hypodermic syringe coated
Thirumudivakkam, Chennai 600044 Autologous Platelet System with ADP, three way stop cock, filters, saline solution etc
29/Misc/3/2014- M/s. Group Pharmaceuticals Ltd., Devraj BioFilm, a mouth Ulcer Dissolvable Strip intended for
14 Regulated 1/28/2014
DC(05) Bldg, A Wing 4th Floor, S.V. Road, Goregan, 1. BioFilm, Mouth Ulcer topical application to areas of the mucosal surface affected
Mumbai 400062 Dissolvable Strips by minor aphthous ulcers, oral abrasions or cuts
Use the topical closure of surgical skin incisions and
29/Misc/3/2014- M/s. Pushpanjali Medi India Pvt. Ltd., trauma induced laceration in areas of low skin tension
15 Regulated 1/28/2014
DC(06) Gandhi House, 16, Ganesh Chandra Avenue, 1. Glustitch-Twist Topical uncomplicated skin lacerations where there is little or no
5th Floor, Kolkata 700013 Tissue Adhesive tissue loss.
29/Misc/3/2014-
16 M/s. Sharma Dental Supply Co. Newal 1. CollaPlug-C, Hemostatic Regulated 1/28/2014
DC(04)
Kishore Road, Hazratganj, Lucknow 226001 Collagen Sponge Use as Hemostatic Agent
M/s. ISCON Surgicals Ltd., B-70, Marundhar
29/Misc/3/2014-
17 Industrial Area, Phase-II, Bansi, Jodhpur, 1. Bone Marrow Biospy Needle- Regulated 2/25/2014
DC(09)
Rajashtan-342005 Unsterile Bulk
M/s. Virdis BioPharma Pvt. Ltd., 6/10 Jogani
29/Misc/3/2013-
18 Industrial Complex, V.N. Purav Marg, Regulated 2/25/2014
DC(151)
Chunabhatti, Mumbai 400022 1. Dental Sealant
M/s. Surgimedik Healthcare, 1B-904, Green
29/Misc/3/2014-
19 Acres, Lokhandwala Complex, Andher (W), Regulated 3/7/2014
DC(12)
Mumbai-400053 1. Dexell Use for Vesicoureteral Reflux (VUR)
M/s. Deputy Drugs Controller (I), CDSCO
29/Misc/3/2014-
20 (South Zone) 2nd Floor, Shastri Bhawan 1. Negative Pressure Wound Not Regulated 4/23/2014
DC(24)
Annexe 26, Haddow Road, Chennai-06 Therapy Machine
M/s. Clairvoyance Consulting, Flat No. 801,
29/Misc/3/2014-
21 8th Floor, Indra Prakash Building, 21 Use in providing grip on outer support sheaths, dilator Not Regulated 4/30/2014
DC(21)
Barakhamba Road, New Delhi-110001 1. TorqMax sheaths and spectranetics laser sheathsM/s. Surgimedik Healthcare India Pvt. Ltd.,
29/Misc/3/2014- Surgimedik House, 53 CD, Kandivali Co-
22 Regulated 4/30/2014
DC(23) operative Industrial Estate, Charkop,
Kankivali West, Mumbai-40067 1. Guidewires
M/s. Wellness Concepts, 10, Om Use as an adjunctive therapy for reducing the frequency of
29/Misc/3/2014-
23 Appartments, Sundervan Complex, Near Sab seizure in patients who are refracory to antiepileptic Not Regulated 4/30/2014
DC(10)
TV, Andheri (W), Mumbali-400053 1. FitNes medications
M/s. Genesee Criticare Device Pvt. Ltd., 303, Use for the temporary circulatory support as Ventricular
29/Misc/3/2014-
24 Aggarwal Complex, Block A-1, LSC, Assist device by optimal unloading of ventricle to recover Regulated 5/2/2014
DC(07)
Janakpuri, New Delhi-110058 1. The Tandem Heart System from cardiogenic shock
29/Misc/3/2013- Dr. V. Bhujanga Rao, 29, DRDO Bhawan, By this directorate under the category of Internal Prothetic
25 Regulated 5/5/2014
DC(28) Rajaji Marg, New Delhi-110011 1. Cochlear Implant Replacement
M/s. Nanz Med Scinces Pharma (P)Ltd.,
29/Misc/3/2014-
26 Rampur Ghat, Paonta Sahib, District Sirmour, 1. Isopropyl Alcohol/ Pre Regulated 5/6/2014
DC(31)
H.P Injection Swabs
1. Mirasol Platelet Disposabale
Kits for Tretment in Plasma
2. Mirasol DOUBLE + Platelet
29/Misc/3/2014- Disposable Kit for Treatment
27 Regulated 5/6/2014
DC(19) in plasma
3. Mirasol Platelet Disposable
Kit for treatment in Platement
M/s. Terumo Penpol Ltd., Deviprabha, T.C Additive Solution
9/1330(15) Kattachal Bhagavathy Lane, 4.Mirasol DOUBLE + Platelet
Sasthamamgalam, Thiruvananthapuram- Disposable Kit for treatment in
695010 Platelet Additive Solution Use for the treatment in plasma/ platelet additive solution
29/Misc/3/2013- M/s. India Medtronic Pvt. Ltd., 4-16 Mohan 1. Deep Brain Stimulation Kit,
28 Not Regulated 5/15/2014
DC(179) Co-operative Industrial Estate Ltd., Ground Spinal Cord Stimulation Kit, Intended to deliver electrical stimulation to selected areas of
Floor, Mathura Road, New Delhi-110044 Intersim Test Stimulation Kit the brain, spinal cord or peripheral nervous systems
Prof. N. Khandelwal President, Indian Society
of Vascular & Interventional Radiology
29/Misc/3/2013-
29 Department of Neuroradiology, CN Centre, Regulated 5/21/2014
DC(26)
Room No. 15, AIIMS, Ansari Nagar, New 1. Polyvinyl Alcohol Foam
Delhi-110029 (PVA)
M/s. Abbott Healthcare Pvt. Ltd., Intended as an adjuant in the management of chemo &
29/Misc/3/2014-
30 Corporate Park Sion Trpmbay Road, radio therpy including oral mucositis or ulcer of the oral Regulated 5/30/2014
DC(39)
Mumbai-400071 1. OROSOL spray mucosa alongwith standard treatment
1. Scalp Vein Infusion Sets
29/Misc/3/2014- 2. Extension Tube
31 Regulated 6/4/2014
DC(34) M/s. Surgiplus, Plot No. 2, 5th Cross, 3. 3 Way stopcock
Gnanaprakasam Nagar, Pondicherry-605008 4. Disposable SyringeM/s. Terumo Penpol Ltd., Deviprabha, T.C
29/Misc/3/2014- 9/1330(15) Kattachal Bhagavathy Lane, 1. Spectra Optia Exchange set
32 Regulated 6/4/2014
DC(22) Sasthamamgalam, Thiruvananthapuram- 2. Cobe Spectra Product
695010 3. Trima Accel Product
Mr. S S Bhatia Col, Dy. Commandant,
29/Misc/3/2014-
33 Armed Forces Medical Stores Depot, Delhi Regulated 6/6/2014
DC(48)
Cantt-10 1. Ligating Clips
M/s. Medilinks Inc., 03, Noble House, Gr.
29/Misc/3/2014-
34 Flr, Dr. Batliawala Labe Parel, Mumbai- 1. External Breast Prosthesis Not Regulated 6/9/2014
DC(42)
400012 Maxima
Use to support the body's fundamental physiological
29/Misc/3/2013- M/s. Earthrays Pvt. Ltd., 48 Qutab View process,thereby promoting the improvement of natural self
35 Not Regulated 6/9/2014
DC(190) Apts., Shaheed Jeet Singh Marg, New Delhi- 1. BEMER (Sets, PRO & regulatory mechanishm on micorcirculations, immune
110016 Classic) system, protein synthesis
M/s. Win Medicare Private Ltd., 1400, Modi 1. Contractubex OIP
29/Misc/3/2014-
36 Tower, 98 Nehru Place, New Delhi-110019, (Overnight Intensive Patches) Regulated 6/25/2014
DC(17)
India Transdermal Patches
Mr. Samir Mehta, Bio-Medical Engineer, C-
29/Misc/3/2014- 150, Oshiwara Industrial Centre, Opp.
37 Regulated 7/4/2014
DC(50) Oshiwara Bus Depot, New Link Road, 1. Esophagel Stent & Biliary
Goregaon (west) Mumbai-400104 Stent2015 Database
File . No. Name of the Company and Address Product Name Intended Use Regulatory
Date of Issue
S. NO. Status
1 29/Misc./3/2014-DC M/s. Nirma Limited, Nirma House, Duragraft-Vascular Conduit Storage For the preservation, Storage and flushing of vascular
(207) Ashram Road, Ahmedabad-380009 Solution conduitsprior to grafting in vascular surgeries Not Regulated 01.01.2015
Gujarat
2 29/Misc./3/2014-DC M/s. Biomet Orthopaedic India Pvt. Ltd., Abutments
(176) office no. - 811, Building No. 08, " Internal Prosthetic Replacements"
Solitaire Corporation Park, Andheri
Regulated 01.01.2015
Ghatkopar Link Road, Chakala, Andheri
East, Mumbai - 400093
3 29/Misc./3/2014-DC M/s. Phoenix Cardio Care India Pvt. Inflation Device Consisting of Syringe,
(97) Ltd., 53, Syed Amir Ali Avenue, 3rd tubing etc. intended ot be used in the intervention
Floor, Suite-3B, Kolkata-700019 operation which is to be connected with ballon catheter
and could supply liquor pressur to make the balloon Regulated 01.01.2015
catheter inflating and deflating
4 29/Misc./3/2014-DC M/s. Vigen Healthy Tech India pvt. Ltd., "TOP 8500-Special" For body massage
(146) Plot no. 16-17, Near Brahma Appartment
Sector-7, Dwarka, new Delhi - 110075 Not Regulated 05.01.2015
5 29/Misc./3/2014-DC M/s. Neurosynaptic Communications Tele-Medicine Solution Its components which measures basic physiological
(161) Pvt. Ltd., #10, 29th Main, BTM Layout ReMeDi (Remote Medical parameters and provide information about the patient
II Stage, Bangalore-560076 Diagnostics, which is Telemedicine health Not Regulated 15.01.2015
Solution)
6 29/Misc./3/2014-DC M/s. Serum Institute of India Ltd., 212/2 Stratis Needle Free Injector System Use auto disable needle free jet injecto intended to
(150) Hadaspar, Pune-411028 deliver the fluid volumes either intramuscularly (IM)
of Subcutaneously (SC) by means of High velocity
fluid jet & " stratis reset station" used to prepare (set) Not Regulated 19.01.2015
the injectior spring for an injection
7 29/Misc./3/2014-DC M/s. Nutri Synapzz Therapeutix Pvt. EZ Partum Obstetric Gel (EZ Partum) Highly Bioadhesive and has a high water-binding
(188) Ltd., capacity. This product is used during natural delivery
No. 203, 2nd Floor, BEML 4th stage, to make the birth easier for both mother and child and
Rajarajeswari Nagar, Bangalore-560098 to protect the perineum. It has no pharmacological Not Regulated 21.01.2015
activity.8 29/Misc./3/2014-DC M/s. Zywie Medical Devices pvt. Ltd., # Pressure Right Pressure Right non-drug, externally applied,
(192) Manjeera Majestic Commercial, JNTU- disposable , single use P6 acupressure, adhesive wrist
Hitech City Road, Kukatpally, strip to be applied on both wrist during use: indicated
Hyderabad-500085, Telegana, India for the relief of emetic (nausea and vomiting) symtoms. Not Regulated 28.01.2015
9 29/Misc./3/2014-DC M/s. Orbit Lifesciences Pvt. Ltd., Gala EdgeFile Heat Treated Firewire NiTi EdgeFile Heat Treated Firewire NiTi Reciprocating
(205) No. 1, Building No. G, Ground Floor, Reciprocating Files Files is an instrument indicated for the removal of
Phase-II, Munisurat complex, Survey dentin and root canal shaping.
No. 122, Village Rehnal, Bhiwandi Dist. Not Regulated 30.01.2015
Thane, Tal: Bhiwandi (Thane-Zone5)
Pin:421302
10 29/Misc./3/2014-DC M/s. J Mitra & Bros., P.O.Box : 2809, 20 HeartWare Ventricular Assist System
(33) Double Storey Market, New Rajinder
Nagar, New Delhi-110060 Not Regulated 03.02.2015
11 29/Misc./3/2014-DC M/s. Well-Tech Imports and Exports (P) O2 VIGOR PORTABLE CANNED O2 VIGOR PORTABLE CANNED OXYGEN is
(163) Ltd., B4 & B5, Jeevarathinam Maaligai, OXYGEN considered under "Medical Oxygen" as specified in
No. 25, Arcot Road, Vellore-632004, India Pharmacopoeia (IP) 2014 "Drug" Regulated 05.02.2015
Tamil Nadu, India
12 29/Misc./3/2014-DC M/s. Duraant Biologicals Ltd., 1- Perfadex For flushing, storage and transportation of isolated
(51) 98/9/12A, 2nd Floor, Jain Enclave, T & lungs after removal from the donor in prepation for
Not Regulated 05.02.2015
A Plaza, madhapur, hyderabad 500081 extenal transplantation into a recipient
13 29/Misc./3/2014-DC M/s. Chitrarth, 5, Dasshan bhawan , Sureseal XL - self activating pressure
(124) hr/62A, Sohan Lal marg, pul pahladpur, dressing
Regulated 11.02.2015
new delhi - 110044
14 29/Misc./3/2015-DC M/s. Galderma India Pvt. Ltd., Lotus Pix L® and Pix'L® + Cannulas Pix' L® ( Pix' L® 27 G, Pix'L® 25G, Pix'L® 23G) and
(02) Corporate Park, D Wing Unit 801 & 802, Pix'L® + (Pix' L® +28G, Pix'L® + 25G) are needles &
Graham Firth Steel Compund, Western cannulas for single use sterile for dermal, subcutaneous
Express Highways, Goregaon Tal: and supraperiosteal deposties of hyaluronic acid for Regulated 11.02.2015
Goregaon (East), Mumbai facial tissue augmentattion.
15 29/Misc./3/2015-DC M/s. Novateur Electrical & Digital Blood presure cuffs, stechscope,
(14) Systems Pvt. Ltd., 61/62, 6th Floor, probes, thermometer, telemedcare
Kalparatu Square, Kondivita Road, Off portable health monitor, etc.
Not Regulated 11.02.2015
Andheri kurla road andheri (e ) , mumbai
- 400059
16 29/Misc./3/2015-DC M/s. Piramal enterprises limited, 320 radiopharmaceutical product " Neuraceq™ )florbetaben F18 injection) is a
(17) tower-B, DLF Towers, jasola, new delhi Neuraceq™ (Florbetaben F18 radiopharmaceutical product meant for early diagnosis
110025 injection) of Alzheimer's deisease Regulated 19.02.201517 29/Misc./3/2015-DC M/s. South India Surgical Co. Ltd., OMT spetzler Neuro patties OMT spetzler Neuro patties" are non-absorbent
(4) 177/65, Wallajah road , chennai - surgical sponges intended ofr control of hemorrhage
600002 and protection of tissues weaves & delicate structures
during surgery as well as for absorption & drying of
corporal fluid that limits the vision of the surgical field Regulated 09.03.2015
during procedure. (Surgical Dressing)
18 29/Misc./3/2015-DC M/s. Mtex India Pvt. Ltd., a-26/4, mohan Synthetic casting Tape synthetic casting tape ' consist of knitted fiberglass
(30) c0-operative industrial estate, mathura (polyester) fabric impregnated with polyurethane resin
road, new delhi-110044 when exposed to moisture of water initiate a chemical
Regulated 09.03.2015
reacton which cause tape to become rigid.
19 29/Misc./3/2015-DC M/s. Timpac Healthcare Pvt. Ltd., -169, Density PRP Test Tubes with Density PRP Test Tubes with separating Gelx2" the
(09) Naraina Industrial Area, Phase-I, New separating Gelx2 tubes with anticoagulant such as Sodium Floride Gel
Delhi-110028 etc., used ofr the purpose of collecting and transporting
Regulated 10.03.2015
blood samples for testing at clinical
laboratories/Centrifugatuon.
20 29/Misc./3/2015-DC M/s. Sun Pharmaceutical Industries ltd., Starhaler Device Starhaler Device" which is meant to collect user's
(19) tandalja vadodara - 390020 respiratory flow profile data Not Regulated 10.03.2015
21 29/Misc./3/2015-DC M/s. Motivation India, No.1436 Ground Wheelchair trials Development & testing of an affordable tilt in space
(40) Floor, BTS Depot , Hennur Main Road pediatric wheelchair for less resource setting.
Bangalore-560043 Not Regulated 10.03.2015
22 29/Misc./3/2015-DC M/s. Meril Life Sciences pvt. Ltd. Survey Merigraft pericardium covered stent product for examination, testing and analysis .
(144) no. 135/2/A, near g m bilakhia stadium graft system.
Regulated 26.03.2015
muktanand marg chala vapi - 396191
23 29/Misc./3/2015-DC M/s. Tara Lohia Distributors, 24, Sri ram Smart breathe Smart Breathe' smart breathe is a device internded to
(44) road , civil lines, delhi - 110054 increase the oxygen supply to the cells increasing the
immine system stronge and increasing protection of the
Not Regulated 26.03.2015
body from viruses, microbes, parasites etc.
24 29/Misc./3/2015-DC M/s. Paviour pharmaceuticals pvt. Ltd., caphosol caphosol' with the composition of dibasic sodium
(57) 311-312 suneja tower-1, distt centre, phosphate 0.032 %w/w, monobasic sodium phosphate
janak puri, new delhi-110058 0.009 %w/w, calcium chloride 0.052 % w/w, Sodium
Chloride 0.569 % w/w) which is also indicated as "an
adjunct to standard oral care In the prevention and Regulated 27.03.2015
treatment of the mcositis that may be cased by
radiation or high doe chemotherapy.25 29/Misc./3/2015-DC M/s. Meril Life Sciences pvt. Ltd. Survey Chronic Occlusion (CTO) Device Chronic Occlusion (CTO) Device a sinle use,
(145) no. 135/2/A, near g m bilakhia stadium disposable, sterile catheter for the purpose of
muktanand marg chala vapi - 396191 examination, test or analysisonly at M/s. Merillife Regulated 27.03.2015
sciences pvt. Ltd.
26 29/Misc./3/2015-DC M/s. Meril Life Sciences pvt. Ltd. Survey Intracoronary Shunt a terile, single use disposable shunt composed of two
(142) no. 135/2/A, near g m bilakhia stadium bulbs on the distal ends of a flexible shaft for the
muktanand marg chala vapi - 396191 purpose of examination, test or analysis only M/s.
Meril Life sciences pvt. Ltd., survey 135/2/A, near g m Regulated 27.03.2015
bilakhia stadium, muktanand marg, chala, vapi 396191
27 29/Misc./3/2015-DC M/s. Meril Endosurgery Pvt. Ltd., Survey Bone Wax Bone wax which is indicated to aid in the control of
(58) no. 135/2/A, near g m bilakhia stadium bleeding in bone injuries is regulateed as surgical
Regulated 27.03.2015
muktanand marg chala vapi - 396191 products
28 29/Misc./3/2015-DC M/s. Siro Clinpharm Pvt. Ltd., DIL SpO2 sensors and pulse oximeter SpO2 sensors and pulse oximeter monitors : (a)
(42) Premises, 2nd Floor, Swami Vivekanand monitors Nellcor N600x Pulse Oximeter monitors (b) Low Acity
Road, Near Tatwagyan Vidyapeeth, Multi-parameter (LAMP) family of monitors ( c ) Not Regulated 30.03.2015
Ghodbunder Road, Thane (west) - Masimo Radical-87 monitors
400610
29 29/Misc./3/2015-DC M/s. Meril Life Sciences pvt. Ltd. Survey Fractional Flow Reserve (FFR) Fractional Flow Reserve (FFR) Pressure Guidewire is a
(140) no. 135/2/A, near g m bilakhia stadium Pressure Guidewire steerable guidewire with a ultra micron pressure sensor
muktanand marg chala vapi - 396191 die mounted 30 mm form the radiopaque tip of the
guidewire for the purpose of examination, test of
analysis only at M/s. Meril Life Sciences pvt. Ltd. for test NOC 01.04.2015
Survey no. 135/2/A, near g m bilakhia stadium
muktanand marg chala vapi - 396191
30 29/Misc./3/2015-DC M/s. Accredited Consultants Pvt. Ltd., D-Swabable Vial Adapter Swabable Vial Adapter is a transfer device intended
(47) 29, First Floor, Acharya Niketan, Mayur for safe and easy transfer of liquid drug from & into
Vihar - 1, Delhi - 110091 vial as a part of or through syringes before Regulated 21.04.2015
administration to the patients.
31 29/Misc./3/2015-DC M/s. Kentron Biotechnology Pvt. Ltd., a) Transuretheral Microwave Therapy a) intended for the treatment of symptomatic Benign
(46) No.8, 1st Floor, 1st Block, 15th Cross, Device Prostatic Hyperplasia in men a) not regulated
21.04.2015
R.T. Nagar, Bangalore-560032 b) Prolieve System Treatment Catheter b) Regulated
b) used in the device
32 29/Misc./3/2015-DC M/s. Paul Hartmann Medical Pvt. Ltd., Hydroclean Plus, Hydrotac, Zetuvit, these products are wound dressing products used in
(73) B/506, 5th Floor, Titanium Square, Zetuvit Plus, Permafoam, Cosmopore healing of wound and management
Thaltej, Ahemedabad - 380059, Gujarat IV, Hydrofilm IV, Hydrofilm IV Regulated 29.04.2015
control and Peha-haft LF33 29/Misc./3/2015-DC M/s. Merz India Healthcare Pvt. Ltd., Ulthera System use as a non-invasice dermatological aesthetic tratment
(81) Level 3, Office No. 337, Neo Vikram, to lift eyebrow, lax submental and neck tissue
Above audi show room, New Link Road, Not Regulated 29.04.2015
Andheri (W), Mumbai -400053
34 29/Misc./3/2015-DC m/s. Fresenius kabi India Pvt. Ltd., Freedlex Transfer Adapter indicated to drug transfer from Vials to Freeflex in
(74) Registed office & factory, A-3, MIDC, close system
regulated 29.04.2015
Ranjangaon Ganpati, Tal: Shirur, Dist.
Pune-412220
35 29/Misc./3/2015-DC M/s. Elite Jair Studio Pvt. Ltd., 1-11- Hair Max Laser Comp Advances 7, intended to treat androgenetic alopecia and promote
(77) 252/12, Motilal Nehru Nagar, Begumpet, hair Max Laser Comb Lux 9 and Hair hair growth
Not Regulated 29.04.2015
Hyderabad, India Max Laser Comb Professional 12
36 29/Misc./3/2015-DC M/s. CliniExperts Service Pvt. Ltd., 112, Zip 8i surgical skin closure device and indicted for non-invasive surgical skin closure
(82) 113, 114, C-58, Shahpuri Tower, Zip 16 surgical skin closure device
Regulated 29.04.2015
janakpuri, New Delhi - 110058
37 29/Misc./3/2015-DC M/s. Becton Dickinson India Pvt. Ltd., BD Uniject™ DP Prefillable Delivery is a containe closure system for packing and
(66) 5th & 6th Floor, Signature Tower-B, System installation of vaccines and potentially oral drugs
Not Regulated 29.04.2015
South City-1, Gurgaon-122001
38 29/Misc./3/2015-DC M/s. India Medtronic Pvt. Ltd., 1241, The Pillar System- Palatal Implants consisting of a delivery tool and an implant i.e. 14
(07) Solitaire Corporate Park, building Gauge needle intended for use in stiffening the soft
Number 12, 4th Floor, Andheri- palate tisseu as such the said product Regulated 30.04.2015
Ghatkopar Link Road, Andheri (E),
Mumbai - 400093, Maharashtra
39 29/Misc./3/2015-DC M/s. LifeCell International Pvt. Ltd., Umbilical Cord Blood Collection Kit intended to facilitate sterile collection of cord blood
(130) #26, Vandalur Kelambakkam Main Boxes and tissue
for export NOC 30.04.2015
Road, Keelakottaiyur, Chennai-600127
40 29/Misc./3/2015-DC M/s. Observe Design Pvt. Ltd., Level-3, Sakshield- Hand Sanitizer Dispenser Hand sanitizer Distepnser (without any disinfectant or
(72) C-28, Malviya Nagar, New Delhi- sanitizer) which dispenses hand sanitizer using a Not Regulated 05.05.2015
110017 mechanical or an electroniv mechanism
41 29/Misc./3/2015-DC M/s. KOB Medical Textiles Pvt. Ltd., Novopress LF-T 752 and Rinkilastic products are latex free elastic, non-woven,
(75) No. 116, Trichy Road, Ondipudur, Cohesive 184 LF hydrophobic cohesive elastic bandage Regulated 05.05.2015
Coimbatore -641016, Tamilnadu
42 29/Misc./3/2015-DC M/s. Denex International, H No. 169P, a) catheter mount
(76) Sector 14, Huda, Gurgaon -122001 b) clave connector
c) connectors
d) umbilical Catheter
e) corrugated drain Sheet
f) urine collection bag
g) Mucus Extractor Regulated 05.05.2015
h) 3 - way stop cock
i) Extension line
j) Manifold
k) closed wound drainage set (VAC
Set) and
l) skin stapler43 29/Misc./3/2015-DC M/s. Denex International, H No. 169P, a) Umbilical Cord Clamp
(76) Sector 14, Huda, Gurgaon -122001 b) lung Exercizer
c) Oxygen Mask
Not Regulated 05.05.2015
d) Surgical Blades
e) Blood lancets and
f) Disposable Hygiene wear
44 29/Misc./3/2015-DC M/s. Chandra Corporation, 102, Konark Orthopaedic Casting Tape used to keep a broken bone in place while it heals
(71) Opp. Sadhanagar, nr. Chepi Rog
Regulated 05.05.2015
Hospital,Vedmandir road, karelbaug,
vadodara -390018
45 29/Misc./3/2014-DC M/s. Emergo (india) Consulting Pvt. β-powder -β-Tricalcium Phosphate (β intended for cleaning and polishing patient's tooth
(76) Ltd., 8/1, First Floor, Vasavi Colony, TCP) surface by emitting the powder from an airbrush under
Kakaguda, Near Picket, Secunderabad, air or water pressure Not Regulated 07.05.2015
MCH-Circle-7, mandal, Hyderbad -
500009 A.P.
46 29/Misc./3/2014-DC M/s. Meril Endosurgery Pvt. Ltd., Survey Absorbable Heostat (Oxidized a sterile, absorbable knitted fabric used adjunctively in
(70) no. 135/2/A, near g m bilakhia stadium regenerated cellulose) surgical procedures to assist in the control of capillary,
muktanand marg chala vapi - 396191 veous and small arterial hemorrhage when ligation or
other conventional methods of control are impractical
or ineffective for the purpose of examination, test or for test NOC 12.05.2015
analysis only at M/s. Meril Endosurgery Pvt. Ltd.,
Survey no. 135/2/A, near g m bilakhia stadium
muktanand marg chala vapi - 396191
47 29/Misc./3/2015-DC Dr. V.G. Mohan Prasad, VGM Hospital, Endoscopic Tubes / pipes basic endoscopic device (flexible endoscope with 3
(96) 2100, Trichy Road, Coimbatore-641005, internal lumens and around 130cm. Long tube). Regulated 18.05.2015
Tamilnadu
48 29/Misc./3/2015-DC M/s. Shree Pacetronix Ltd., Plot No. 15, Cardiac Pacemaker
(100) Sector II, Pithampur, dist. Dhar, Madhya Not Regulated 18.05.2015
Pradesh-454775
49 29/Misc./3/2015-DC M/s. Regulatory Solutions India, F-2/13, Minitouch Device intended for ablation of the endometrial lining of the
(47) DLF Qutub Enclave, Phase-I, Gurgaon, uterus for the tratment of menorrhagia ( excessive
haryana-122002 uterine bleeding) due to benign causes in Not Regulated 18.05.2015
premenopausal women for whom child bearing is
complete
50 29/Misc./3/2015-DC M/s. Johnson & Johnson Pvt. Ltd., 9/43, Sterile Lancet used to prick the skin for blood sampling
(118) Kirti Nagar, New Delhi - 110015 Not Regulated 20.05.2015
51 29/Misc./3/2015-DC M/s. Emcure Pharmaceuticals Limited, T-Histidine-Typtophan-Ketoglutarate intended for flushing, storage and transportation of
(104) 184, M.I.D.C. Bhosari, Pune-411026 (HTK) Solutions isolated lungs after removal from the donor in
Not Regulated 22.05.2015
preparation for external transplantation into a recipient
52 29/Misc./3/2015-DC M/s. Ortho Prime, 470, Jawahar Marg Fiberglass Orthopedic Tape used as a casting tape in case of treatment of fractures
Regulated 22.05.2015
(119) Siyaganj, Indore-45200753 29/Misc./3/2015-DC M/s. Scepre Medical (India) Pvt. Ltd., Unfinished & Unsterile Products Unfinished & Unsterile components of catheter,
(80) 14, 1st Floor, Central Market, Ashok guidewire, dialator, hollow syringe, introducer needle, goods are not covered
Vihar, Phase-I, Delhi-110052 stylet, trocar, needle wings, PVC Tube, Luer Locks/ under the provision of
26.05.2015
connectors, clamp etc. for the purpose of further drugs and cosmetics act
manufacturing like cutting, molding, assembling for 1940 and rules thereunder
finished goods
54 29/Misc./3/2015-DC Mr. mukesh Kumar, Inspector of Police, Film for medical radiography
(67) Central Bureau of Investigation, anti
corruption branch, plot no. 5B, CGO Not Regulated 02.06.2015
Complex, Lodi Road, New Delhi-
110003
55 29/Misc./3/2014-DC M/s. Regulatory Solutions India, F-2/13, Minitouch Device intended for ablation of the endometrial lining of the
(47) DLF Qutub Enclave, Phase-I, Gurgaon, uterus for the tratment of menorrhagia ( excessive
haryana-122002 uterine bleeding) due to benign causes in Not Regulated 09.06.2015
premenopausal women for whom child bearing is
complete
56 29/Misc./3/2015-DC M/s. Durent Biologicals Ltd., 1- THAM-trometamol, tris- intended to adust the pH to 7.4 of Perfadex® solution
(136) 98/9/12A, 2nd Floor, Jain Enclave, T & hydroxymethyl aminomethane (used for flushing, storage and transportation of
A Plaza, Madhapur, Hyderabad-500081 isolated lungs after removal from the donor in Not Regulated 12.06.2015
preparation for eventual transplantation into a
recipient)
57 29/Misc./3/2013-DC M/s. India Medtronic Pvt. Ltd., A-16, Synchromed pump without catheter
(179) Mohan Cooperative Indus Estate Ltd.,
Not Regulated 16.06.2015
Ground Floor, Mathura Road, New Delhi-
110044, India
58 29/Misc./3/2015-DC M/s. Gel Craft Healthcare (P) Ltd., 306, C₃I Gel™ Technology based products
(127) Deepshikha Building, 43 veer savarkar
Not Regulated 16.06.2015
Block, shakarpur, vikas marg, delhi-
110092
59 29/Misc./3/2015-DC M/s. Galderma India Pvt. Ltd., Lotus Pix'L® and Pix'L® + cannulas there is no provision for import of device/drug for
(02) Corporate Park, D Wing Unit 801 & 802, demo purpose
Graham Firth Steel Compund, Western
19.06.2015
Express Highways, Goregaon Tal:
Goregaon (East), Mumbai
60 29/Misc./3/2015-DC M/s. Prowin Health Technologies Pvt. Smart Coat (Nano Titanium Dioxide) The product smart coat containsn n-type
(162) Ltd., B-18, 1st Floor, Vengalarao Nagar, semiconductor photo-catalyst, as an active ingredien
Opp Post Office, S. R. Nagar, Hyderabad whice are nao-sized Titanium Dioxide (TiO2)
- 500038 particles. It is applied by spraying on to a designated
Not Regulated 16.06.2015
surface, or any other such as walls, ceiling,
curtains,cupboards, cushions and almost every surface
including glasses which require full transparency
61 29/Misc./3/2015-DC M/s. Lakshmi Life Sciences Ltd., 3/284 1. closed suction catheter (sterile) -
(143) A, Sulur Railway Feeder Road, catheter
Kurumbapalayam, M.G. pudur (PO), 2. 3 way stop cock with extension
Regulated 19.06.2015
Coimbatore-641406 (Sterile) - Disposable Perfusion Set
3. Yankur suction Set (Sterile) -
catheter62 29/Misc./3/2015-DC Mr. mukesh Kumar, Inspector of Police, a). Under the category of Disposable Hypodermic
(88) Central Bureau of Investigation, anti Needle which were notified vide G.S.R. 365(E)
corruption branch, plot no. 5B, CGO b) does not come under the preview of Drugs & 30.06.2015
Complex, Lodi Road, New Delhi- a). Vaccutainers fitted with needle Cosmetics Act a) regulated
110003 b). Vaccutainers without Needle b) not Regulated
63 29/Misc./3/2015-DC M/s. Happy Medicare Pvt. Ltd., Plot No. Automatic massage bed, waist belt, not notified as medical devices under the provisions of
(156) 1, Palam Kunj, Near Ramphal Chowk, mint mat, cusion and single mat Drugs & Cosmetics Act
Not Regulated 30.06.2015
Palam Extension, Sector-7, Dwarka,
New Delhi-110075
64 29/Misc./3/2015-DC M/s. Sahaj Regenerative Cell Cole-Parmer (Ultrasonic Processors) which is an equipment for homogenisation of tissue in
(152) Therapeutics LLP, 13/2, South laboratory Not Regulated 03.07.2015
Tukoganj, Indore, madhya Pradesh
65 29/Misc./3/2015-DC M/s. Eleven2Six Store, WZ-1367, Rani Master-Aid Ortopad (Orthoptic Eye indicated to act as mechanical barrier for eye treatment
(93) Bagh Shakur Basti, New Delhi-110034 Patch) of strabismus (Lazy eye) and amblyopis and for Not Regulated 07.07.2015
campimetry
66 29/Misc./3/2015-DC m/s. Creative Resposible Integrated G-1 Negative Pressure Ventilator
(153) System Foundaton, Ground Floor, (Portable Ventilator)
Not Regulated 07.07.2015
Madhav Baug, Brahmin Society,
naupada, Thane-400602, Maharashtra
67 29/Misc./3/2015-DC M/s. Meril Endo Surgery Pvt ltd., Survey Ligating Clips use in surgery for vessel closer as well as for making
(158) No. 135/2/B and 174/2, Third Floor, E1- purposes
E3, Meril park, muktanand Marg, Chala, Regulated 15.07.2015
vapi, Dist. Valsad-396191
68 29/Misc./3/2015-DC M/s. Healthy Options Pvt. Ltd., 14, Electric Massaging Equipment
Not Regulated 15.07.2015
(158) Vigyan Vihar, Delhi-110092
69 29/Misc./3/2015-DC M/s. Amarante Wellness Zone, 14, electric equipments viz., beauty
(155) Vigyan Vihar Sports Complex, Opp. machine, massaging machine etc. Not Regulated 17.07.2015
HDFC Bank, New Delhi-110092
70 29/Misc./3/2015-DC M/s. Wealth Taxi Technology Pvt. Ltd., iRemeber (A Smart Pill Organizer)
(150) 24/4818, First Floor, Prahlad Street,
Not Regulated 17.07.2015
Ansari Road, Daryaganj, new Delhi-
110002
71 29/Misc./3/2015-DC M/s. WomenCare Global International, CAYA SILCS Diaphragm which is indicated for prevention of pregnancy is
(145) 160 Chesterfield Dr # 2, Cardiff, CA regulated as drugs under section 3, clause (b), sub Regulated 21.07.2015
922007, United states clause (ii)
72 29/Misc./3/2015-DC M/s. CareFusion, 22745 Savi Ranch AVEA Ventilator care products 1. AVEA Ventilator Esophageal Pressure Monitoring
(79) Parkway, Yorb Linda CA 92887-4668, tube set
USA 2. AVEA Ventilator Extension Esophageal Pressure
Monitoring tube set (Adult & Pediatric)
3. AVEA Ventilator Nasogasteric pressure monitoring
tube set (Adult & Pediatric) Regulated 24.07.2015
4. AVEA Ventilator varflex/ adapter tracheal pressure
monitioring tube set73 29/Misc./3/2015-DC M/s. Schulke India Pvt. Ltd., A-24/9, Thrmosept Xtra which is a mildy alkaline machine detergent based on
(160) Mohan Co-operative Industrial Estate, surfactants and enzymes for the universal cleaning of
Mathura Road, New Delhi-110044 medical instruments and accessories is not notified as
Not Regulated 24.07.2015
medical device
74 29/Misc./3/2015-DC M/s. Krupa Medix, 3/37, thirumangal Orthopaedics External Fixation used in infected non-unions of fractures which need
(68) Alwar Street, NH-1, Maraimalai Nagar, Products correction and for the boe deformities and bone
tamil nadu pin- 603209 lengthening procedures
Not Regulated
M/s. Corions India Pvt. Ltd., No5, Sri
Krishna Nagar Annexe, maaduravoyal, 29.07.2015
chennai-600095 12.06.2012
75 29/Misc./3/2015-DC Dr. Chetan Bhardwaj, C-15, Green Park Magneto-Therapeutic Devices
Not Regulated 31.07.2015
(141) Main, New delhi-110016 (ALMAG-01 & ALMAG-02)
76 29/Misc./3/2015-DC M/s. Chayagraphics (India) Pvt. Ltd., a) intended for cleaning of endoscopes, surgical
(110) 248, 4th Main Road, Chamarajpet, instruments and accessories
a) not regulated
Bangalore-560018 a) Intercept Detergent b) ------
b) Regulated 31.07.2015
b) Rapicide OPA/28 High Level c) used for the determination of Minimum
c) not regulated
Disinfectant Recommended Concentration (MRC) of ortho-
c) Rapicide POA/28 Test Strips Phthalaldehyde
77 29/Misc./3/2015-DC M/s. Albert David Limited, 4/11, asaf ali Both Sterile and Non-sterile
(163) road, new delhi-110002 Disposable Hypodermic Syringes and
Regulated 03.08.2015
Disposable Hybodermic Needled
78 29/Misc./3/2015-DC M/s. Envision Scientific Pvt. Ltd., Shop Lipoid E80 (excipient) act as a carrier for drug eluting stent systems in the
(166) No. 4, Silver Palm-2, Kadampalli, coating process Not Regulated 04.08.2015
Nanpura, Surat-395001
79 29/Misc./3/2015-DC M/s. Stericate Gutstrings (P) Ltd., Plot a) Sterile Hemostatic clip made of a) Nil
(171) No. 169, ,sector-4, IMT-Manesar, pure Titanium grad-1 b) for sterilization and packing for sale a) regulated
05.08.2015
Gurgaon, haryana b) Hemostatic clips (Raw material in b) regulated
the bulk form of clip)
80 29/Misc./3/2015-DC M/s. Dentspec, C-1987 (First Floor), Improalgin & Hydrocol (Alginate used to take dental impressions and to study models
(175) Sushant Lok-1, Gurgaon -122002 Impression Materials Not Regulated 04.08.2015
81 29/Misc./3/2015-DC M/s. Aramex trading Co., 9-ashok Nagar, Fluor Gel indicated for the prevention (Prophylaxix) of caries
Regulated 04.08.2015
(177) Lucknow, Uttar Pradesh
82 29/Misc./3/2015-DC M/s. Aramex trading Co., 9-ashok Nagar, used for temporary filling of teeth and temporary
(173) Lucknow, Uttar Pradesh 1. Xero Cem (Automix Eugenol-free cementing of crowns
temporary cement)
Not Regulated 04.08.2015
Tfill Eco (Temporary filling Material)
3. Proklene (Prophylaxis Paste
regular)
83 29/Misc./3/2015-DC M/s. LifeCell International Pvt. Ltd., Cord collection clamp used ot collect the umbilical cord blood from umbilical
(174) #26, Vandalur Kelambakkam Main cord during placental delivery of the baby
Not Regulated 12.08.2015
Road, Keelakottaiyur, Chennai-60012784 29/Misc./3/2015- M/s. Chandra Corporation, 102, Konark Orthopaedic Casting Tape used to keep a broken bone in place while it heals
DC(71) Opp. Sadhanagar, nr. Chepi Rog 05.05.2015
Regulated
Hospital,Vedmandir road, karelbaug, 12.08.2015
vadodara -390018
85 29/Misc./3/2015- M/s. Joseph Lesile & Co. LLP, Leslico Water Gel Based Blankets used as a body wrap to extinguish fires and to cool and
DC(181) House, 3rd Floor, Pro. V. s. Agashe Rd., moisten burns
Not Regulated 25.08.2015
Dadar-West, Mumbai-400028
86 29/Misc./3/2015- M/s. CAmbIndia Biotech Kits Pvt. Ltd., cApillary Collection Lancets indicated to prick the finger for blood glucose
DC(188) 208, Pratik Industrial estate, Mulund- monitoring
Goragaon Link Road, Next to Fortis
Not Regulated 25.08.2015
Hospital, Mulund (west), Mumbai-
400078
87 29/Misc./3/2015- M/s. Shreyas Health Care, New No. 73 Voice Prosthesis used by cancer surgeons after removal of larynx and
DC(184) (Old No. 5A), Iind Floor, Lal Bhagathur creating a small surgical puncture on the throat (stoma)
colony, Peelamedu, Coimbatore -641004 and placing the prosthesis in the passage for spreaking
Not Regulated 31.08.2015
88 29/Misc./3/2015- M/s. Becton Dickinson India Pvt. Ltd., BD Uniject Prefillable Injection supplied to pharmaceutical manufactureres as a
DC(138) 5th & 6th Floor, Signature Tower-B, System prefillable drug container with delivery function of
South City-1, Gurgaon-122001 hypodermic needle designed with non-reusable
function for the parenteral administration of drugs of Regulated 31.08.2015
vaccines either through intramuscular of sucutaneous
injection
89 29/Misc./3/2015- M/s. Timpac Healthcare Pvt. Ltd., -169, Density Platelet Gel comprising of the kit containing set of blood taking test
DC(09) Naraina Industrial Area, Phase-I, New (with needle butterfly, tourniquet, plasters) containing
Delhi-110028 inert gel, syringes and pharmaceutical grade sodium
citrate (ACD-A),used for the purpose of collecting and
transporting blood samples for testing at clinical Regulated 01.09.2015
laboratories/centrifugation
90 29/Misc./3/2015- M/s. Morulaa HealthTech Pvt. Ltd., Plot. The Woodpecker indicated to be used as a rasp device for femoral
DC(202) No. 38, First Floor, Rajeshwari Street, broaching
Not Regulated 01.09.2015
Santhosh Nagar, Kandanchavdi, Chennai-
600096
91 29/Misc./3/2015- M/s. UE Marketing Pvt. Ltd., A-102, iBrest Exam which is a Breast lesion documentation system
DC(204) Universal Paradise, Nanda Patkar Road,
Not Regulated 03.09.2015
Vile Parle (East), Mumbai-400057
92 29/Misc./3/2015- M/s. Johnson & Johnson Pvt. Ltd., LBS Expressew III Suture Needle a retractable needle which is used with expressew III
DC(193) Marg, Mulund (West), Mumbai-400080 flexible Suture Passer designed to pass 2-0 to #2
Not Regulated 03.09.2015
braided surgical through tissue in either arthroscopic or
open surgery93 29/Misc./3/2015- M/s. Meril Endo Surgery Pvt ltd., Survey Ligating Clips used in surgery for vessel closer etc., are regulated as
DC(158) No. 135/2/B and 174/2, Third Floor, E1- drugs under the category of surgical Ligatures
E3, Meril park, muktanand Marg, Chala, (Schedule C) Regulated 03.09.2015
vapi, Dist. Valsad-396191
94 29/CDSCO/Govt./11/2 The Deputy commissioner of customs, A Orthodentic items - brackets,
015-MD R Cargo Complex, Sanganer , Jaipur, archwires, buccal tubes and intra oral Not Regulated 10.08.2016
Rajasthan products
95 29/Misc./3/2015- M/s. Meril Life Sciences pvt. Ltd. Survey Intra coronary Shunt
DC(142) no. 135/2/A, near g m bilakhia stadium
Regulated 08.09.2015
muktanand marg chala vapi - 396191
96 29/Misc./3/2015- The Drugs Controller & Licensing Insupen EX which is an easy to use reusable insulin pen that can
DC(213) Authority, Office of the Drugs deliver insulin doses In inrements of 1 unit to be used
Controller, Government of karnataka, with prefilled 3 ml insulin catrideges for use in the
Not Regulated 21.09.2015
Place Road, bangalore -560001 home environment to aid and support prescribed
treatment and therapy
97 29/Misc./3/2015- M/s. KAI Manufacturing India Pvt. Ltd.,
DC(215) Karan Singh Farm, KH No. 683, Near 1. Surgical Blades
Farm No. 36 & 37, Shivaji Marg, 2. scalpels
Westend Greens, Rangpuri, New Delhi- 3. safety scalpels
Not Regulated 21.09.2015
110037 4. Biopsy Punches
5. Biopsy Punch with Plunger System
6. Dermal Curettes
7. Micro Surgical Scalpels
98 29/Misc./3/2015- M/s. Sesderma India Pvt. Ltd., 6/1517, Nanopore Turbo-Roller which is an electrically Operated micro dark spots
DC(220) Devika Tower-6, Nehru Place, New ecorrector device for aesthetic/cosmetic applicaton of Not Regulated 29.09.2015
Delhi-110019 the skin
99 29/Misc./3/2015- M/s. Mediserve, G-5, Pratap Bhawan , 5, Tubular Bandages - Verba, stulpa-fix used as support and to provide relief to surgical
DC(190) Bahadur Shah Zafar marg, New Delhi- and lastogrip wounds Not Regulated 29.09.2015
110002
100 29/Misc./3/2015- Visualase cooled laser applicator used to necrotize or coagulate soft tissue through
DC(216) system intestinal irradiation or thermal therapy in medicine
and surgery in cargo-vascular thoracic surgery,
dermatology, ear-nose-throat surgery, gastroenterology,
M/s. India Medtronic Pvt. Ltd., 1241,
general surgery, gynecology, head and neck surgery,
Solitaire, Corporate Park, Bldg. No. 12,
neurosurgery, plastic surgery, pulmonology, radiology, Regulated 29.09.2015
4th Floor, Andheri (East), Mumbai-
head and urology for the wavelength range of 800nm
400093
through 1064nm
101 29/Misc./3/2015- The Director, FDA, Goa AED (Automated external which is a portable device that checks the heart rhythm
DC(227) defibrillator) machine by sending an electric shock to the heart to try to
restore a normal rhythm Not Regulated 29.09.2015102 29/Misc./3/2015- M/s. Dr. Schumacher India Pvt. Ltd., 2A, Cleanisept Wipes Maxi having bactericidal, fujgicidal and virus inactivating
DC(217) 2nd Floor, 164, M.G.Road, Pune-411001 properites which is used for thje rapid disinfection and
cleaning of alcohol-sensitive medical devices, medical
Regulated 29.09.2015
quipment as well as of other alcohol-sensitive surfaces
103 29/Misc./3/2015- M/s. Utanco India, 13, tarun enclave, Orthopaedic casting tapes & splint intended for use in the construction of orthopaedic
DC(219) near pushpanjali, pitam pura, delhi- casts, temporary immobilization of fractures, sprains
Regulated 06.10.2015
110034 and strains
104 29/Misc./3/2015- M/s. Sceptre Chemicals Inc., House no. 8-Citric Acid Solution (Disinfectant) used for disinfection of hemodialysis machine
DC(228) A, 2nd Floor, Siri Nagar Colony, Near
Regulated 06.10.2015
Shiva Mandir, Delhi-110052
105 29/Misc./3/2015- M/s. Allergan Healthcare India Pvt. Ltd., Hyaluronic acid 15 mg + Lidocaine
DC(224) No.3, Kasturba Road, Level 2, Pretige Hydrochloride 3 mg ( Juvederm
Obelisk, Bangalore-560001 VOLBELLA with Lidocaine ) and
products Hyaluronic Acie 17.5 mg +
Lidocaine hydrochloride 3 mg Not Regulated 06.10.2015
(juvederm VOLIFT with Lidocaine)
concentration
106 29/Misc./3/2014- M/s. Delhi Eye Zone Pvt. Ltd., D-114, Ferrara Ring- an intraconeal Implants used for correction of patholigical tissue deformities of
DC(125) (G.F.), lajpat nagar-I, New Delhi-110024 the fornea
Regulated 13.10.2015
107 29/Misc./3/2014- M/s. Care Group India, A unit of coneal inlay used for improving the depth of focus by cutting the
DC(125) polymer technologies INTL, Block no. unnecessary light entering in the eye
310, village sim of dabhasa, Ta Padra, Regulated 13.10.2015
Dist. Vadodara-391440
108 29/Misc./3/2014- M/s. Emergo (india) Consulting Pvt. Presbia Flexivue Microlens indicated to improve near vision in adult presbyopic
DC(125) Ltd., 8/1, First Floor, Vasavi Colony, subjects
Kakaguda, Near Picket, Secunderabad, Regulated 13.10.2015
MCH-Circle-7, mandal, Hyderbad -
500009 A.P.
109 29/Misc./3/2015- M/s.Chemours India Pvt. Ltd., 6th floor, Relyon perasafe-medical device used for sterilization on non-surgically invasive
DC(221) Tower-C, DLF cyber greens, sector-25A, sterilant medical devices such as gastorscope of bronchoscope
DLF city phase -III, gurgaon-122002, endoscope, semi-critical medical devices and may be
haryana used as surface disinfectant for decontamination of
mycobacteria and clostridium difficile in high risk Regulated 13.10.2015
areas such as infectious disease isolation wards and
laboratories
110 29/Misc./3/2015- M/s. Johnson & Johnson Pvt. Ltd., LBS Temporary Cardiac Pacing Wire intended for use in temporary cardiac pacing or
DC(223) Marg, Mulund (West), Mumbai-400080 monitoring Not Regulated 14.10.2015111 29/Misc./3/2015- M/s. Global Medicare, Unit No. 1 & 2, Ultroid (Hemorrhoid Management which is an assembly of electrotherapeutic devices to
DC(238) Bawa Potteries Compound, Aruna Asaf System) apply a galvanic direct current to the mucosal tissue
Ali Marg, Vasant Kunj, New Delhi- and indicated for coagulative hemostatic therapy of
110070 internal hemorrhoids, grades I, II, III and IV Not Regulated 09.11.2015
112 29/Misc./3/2015- M/s. Innogen Life Sciences Pvt. Ltd., K- 1. Raw material for post operative surgical wound
DC(237) 384, Surajpur Site V, Kasna Industrial dressigns
area, greater Noida -201308 2. Raw material for post-operative surgical wound
dressings
3. a. Fixation of I.V.Cannula
b. these are suited for post-operative use. They are
useful in accident & emergency for cuts, lacerations
and sutured wounds.
c. fast, efficient & aseptic protection of the puncture
points: parenteral deeding, biopsy & dialysis
Regulated 09.11.2015
d. dressing for ambulatory surgery, post-surgery,
coeliosurgery.
4. fixation of I.V. cannula
1. adhesive Non-woven rolls 5. a. wound dressings for surgical wound/post
2. Absorbent pad rolls operative wound dressing.
I.V. dressing (sterile) b. to dress post-operative wounds, minor cuts,
I.V. dressing (Non sterile) abrasions, lacerations and puncture sites where a water-
5. self-adhesive surgical wound resistant dressing aids in the prevention of bacterial
dressing (sterile) contamination is required.
6. foam dressings (sterile) c. may be used as secondary dressing over gels,
113 29/Misc./3/2015- M/s. Paseca Healthcare LLP., Factory: K-Surgical dressings made up of
DC(120) 68, Sector-3, Bawana Industrial Area, Oxidized Regenerated Cellulose and Regulated 09.11.2015
new Delhi - 110039 Oxidized Cellulose
114 29/Misc./3/2015- M/s. Dentsply India Pvt. Ltd., Kh. No. Dental filling materials, cementing used in dentistry
DC(236) 66/20 & 66/11/2, Gali No. 2, Main material, impression materials
Not Regulated 09.11.2015
Rohtak Road, Mundka Industrial Area,
New Delhi-110041
115 29/Misc./3/2015- Shri Praveen Agarwal, Agarwal Jetley & Product 'sooma tDCS Stimulator' delivers a weak electrical current to the brain via non-
DC(243) Company advocates, A2/78, Safdarjung invasive scalp electrodes intended for treatment of
Not Regulated 20.11.2015
Enclave, New Delhi-110029 depression
116 29/Misc./3/2015- M/s. Paseca Healthcare LLP., Factory: K-
DC(239) 68, Sector-3, Bawana Industrial Area, 1. Hydrocolloid Dressing with Foam
new Delhi - 110039 2. Dressing Wound
Regulated 20.11.2015
3. Tranparent wound medicated
4. polymen dressing
5. pressing post op medicated
117 29/Misc./3/2015- M/s. Ujjawal Overseas (India) Pvt. Ltd., Blood Collection Needles used to collect blood for testing
DC(232) Part-A, Basement, Plot No. 1 & 2, Block
B, Kh. No. 15/7/5/2 & 15/7/8, Raghu Regulated 20.11.2015
Nagar, New Delhi - 110045118 29/Misc./3/2015- M/s. Dr. Schumacher India Pvt. Ltd., 2A, Cleanisept Wipes Maxi having bactericidal, fujgicidal and virus inactivating
DC(217) 2nd Floor, 164, M.G.Road, Pune-411001 properites which is used for thje rapid disinfection and
cleaning of alcohol-sensitive medical devices, medical
quipment as well as of other alcohol-sensitive surfaces Regulated 17.12.2015
119 29/Misc./3/2015- M/s. Helyxon Healthcare Solutions (P) 98.6 Fever-watch used to facilitates monitoring and tracking of the
DC(261) Ltd., IIT Madras Research Park, No.01, infants or babies tempreture
Kanagam Road, Taramani, Chennai- Not Regulated 17.12.2015
600113
120 29/Misc./3/2015- Sh. Major Yogesh Chandra, Sr. water Gel Based Blankets used as a body wrap to extinguish fires and to cool and
DC(181) Manager, Indian Oil Corporation, moisten burns Not Regulated 18.12.2015
Mumbai
121 29/Misc./3/2015- M/s. Argon Impex Pvt. Ltd., 17/306D, woodcast Products are devices indicatd for maintenance of immobilization
DC(189) Valluvaserry, Temple Road, N.F. Gate, of extremities and for supporting soft and hard tissues
Tripunithura P.O. Cochin-682301 e.g. in orthopaedic treatments
Regulated 21.12.2015
122 29/Misc./3/2015- M/s. Instas Life Science Consultancy BEL-GEN & IGL-1 intended for the flushing and the hypothermic storage
DC(286) Pvt. Ltd., No.3, Green Park, Opp. of kidney, liver and pancreas organs at the time of
Yugalkunj Society, B/H Prabhupark organ removal from the donor in preparation for
Not Regulated 29.12.2015
Society, Naroda, Ahmedabad, Gujarat- storage transportation and eventual transplantation into
382330 a recipient
1232015 Database2016 Database
S. NO.
File . No. Name of the Company and Address Product Name Intended Use Regulatory Status Date of Issue
1 29/Misc/3/2015-DC(221) M/s Chemours India Pvt ltd., 6th floor, tower-C, DLF Cyber Greens Sector-RelyOn Perasafe-medical device Sterilization on Non-Surgically Invasive Medical devics such as Gastroscope or Regulated 1/7/2016
25A, DLF City Phase-III, gurgaon-122002, Haryana Sterilant bronchoscope endoscope, Semi-Critical Medical Devices and may be used as a
surface disinfectant for decontamination of mycobacteria and clostridium
difficile in high risk areas such as infectious, disease isolation wards and
laboratories
2 29/misc/3/2015-DC(292) Dr. Rajesh chawla, Principal Investigator, M/s Induraprastha Apollo Pules Oximeters(nonin, masimo and assess the oxygenation status of patients at the bed side Not Regulated 1/7/2016
hospitals, Sarita Vihar, delhi-Mathura road, New Dlehi-110076 philips)
3 29/Misc/03/2013-DC(270) Dr. S. Manivaannon, DDC(I), CDSCO(SZ), Second floor, Shastri bhawan instruments-Orthopaedic instruments used for spine and orthopaedic surgery Not Regulated 1/7/2016
Annexe, 26, haddows road, Chennai-600006
4 29/Misc/3/2016-DC(03) M/s Rithwik Pharma Pvt Ltd., Plot No.11-13, 160/406, ramprathap Nivas CP Relief Wand CP Battery operated Electronic device intended for use as an adjunctive therapy for Not Regulated 1/19/2016
Moyya nagar Colony, Near Asthalakshmi Arch, L.B Nagar, hyderabad, 1000((transcutaneous electrical Nerve pain management
telangana-500074 Stiulator)
5 29/Misc/3/2015-DC(242) Shri. S.K Bhandari, Brig DDCDS(E&S), Dte gen of dental services adjutant Dental Implants the Dental materials used for restoration of tooth, tooth movement and dental lab Not Regulated 1/19/2016
general;s Branch IHQ of moD(army), L Block New dlehi-110002 work for fabrication of dental
6 29/misc/3/2016-DC(026) M/s Barrocyte consultants Pvt Ltd., 105, first floor, Block No-CHBS near Disinfectants Aseptoprint-spray Dentiro light dentiro wipes, isorapid floor, or clean plus Regulated 16-02-2016
mother dairy, sukhdev vihar CSC, New Delhi-110025 oricud-multisept plus orolin burbath, opolin intra & oromed Gel are
disinfectants
7 29/Misc/3/2016-DC(14) M/s Delhi Hopistal supply private Limited 101-103, Pal mohan sadan, Endo staplers Disposable surgical staplers Regulated 16-02-2016
26/32, East Patel nagar rajindra place, New Dlehi-110008
8 29/misc/3/2016-DC(30) M/s Isens Biosensors India Pvt Ltd., unit no.1116-1117, 11th Floor, JMD Safety lancets, Lancets(Normal) and used for blood sampling for diagnostic purpose Not regulated 16-02-2016
Megapolis, shona road, Sector 48, Gurgaon-122001 Haryana lancing device
9 29/misc/3/2015-DC(250) M/s Merck Limited, Shiv sagar Estate, A dr. A.b Road, worli Mumbai- Pyrogen testing(PyroDectect System) kits/reagent intended to be used for the diagnosis of disease or disorder in human Regulated 16-02-2016
400018 beings or animals
10 29/misc/3/2015-DC(159) M/s Lensai opthalmic pvt ltd., A6-101, La habitat, off 100 ft Road thaltej, Punctal Occlusion system extended veraplug punctal occlusion system vera90 extended wear synthetic absorbable Not regulated 16-02-2016
Ahemdabad-380059 wear synthetic absorbable punctal plug punctal plug & vera C7 temporary collagen punctal plugs intended for the
& temporary collagen punctal plugs treatment of dry eye syndrome
11 29/misc/3/2016-DC(12) M/s Jagat diagnostics private Limited B-82, Industrial Area, G.T karnal Lancet used for blood sampling i Not regulated 16-02-2016
Road, New Delhi-3312 29/misc/3/2015-DC(73) M/s paul hartmann medical Pvt ltd., B/506, 5th Floor titanium Square, Cosmopore I.V Hydrofilm I.V and control are surgical dressing materials regulated 16-02-2016
Thaltej Ahemedabad-380059, Gujarat, India Hydrofilm I.V Control
13 29/misc/3/2016-DC(16) Dr. Sharmila Jalgaonkar, member secretary, IEC-I, New UG/PG hostel, Smart sense/Pincolabs(Point of care analyzing blood samples Not regulated 16-02-2016
20th Story hostal building Ground floor, KEM Hospital, near main boys testing(POCT)
hostel Dr. SS Roa's marh, Near parel, Mumbai-400012
14 29/misc/3/2016-DC(23) M/s Pixel care india pvt ltd., third floor, C-435 Defence colony, New Dlehi- Impact(concussion management to measure heart rate, blood pressure and heart anomalies and the device viz not covered under the 16-02-2016
110024 platform) and Ufit(Pulse acquisition impact(concussion management platform) a software based medical device provisions of D7C act
device) intended to assess the baseline and post concussion state of an individual
15 29/misc/3/2015-DC(287) M/s troikaa Pharmaceutical Ltd., commerce house-1, satya marg, bodakdev Soy Phosphatidylcholine Gel 6& for treatment of joint pain associated with osteoarthritis product is not yet 16-02-2016
Ahmedabad-380054 approved
16 29/misc/3/2016-DC(31) M/s Sutures India Pvt Ltd., 472 D, 13th Cross, 4th Phase, Peenya industrial Prosorb Mesh(Composite of form 29 for purpose of examination testing and analysis in india NOC to grant test license 16-02-2016
Area, bangalore-560058 polypropylene and polyglycolic acid) in form 29
17 29/misc/3/2015-DC(152) M/s Sahaj Regenerative Cell therapeutics LLP 13/2, south tukoganj indor , Homogenisation/ultrasonic covitation for homogenisation and ultrasonic cavitation of fat tissue to obtain the stromal Not regulated 16-02-2016
Madhya Pradesh of fat tissue vascular fraction
18 29/misc/3/2016-DC(21) M/s cytocare technologies Pvt Ltd., Hyderabad Cryomacs Freezing bags transfer sets for storage of periphral blood Stem cells and cord blood stem cells, regulated 16-02-2016
and clinimacs reagents
19 29/Misc/3/2015-DC(157) M/s Sutures India Pvt Ltd., 472 D, 13th Cross, 4th Phase, Peenya industrial Trustat(xxidized Regenerated surgical dressings Regulated 23-02-2016
Area, bangalore-560058 Celloulose)
20 29/misc/3/2014-DC(141) M/s Meril Life Sciences pvt Ltd., Survey no.135/2/A, near G.m Bilakhia Myosista Intra Aortic balloon catheter examination testing and analysis of Myosist intra aortic balloon catheter kit permission to manufacture 23-02-2016
Stadium muktanand marg, Chala,Vapi-396191 kits & sale of the product
21 29/misc/3/2016-DC(46) M/s IDS Denmed Pvt Ltd., A-20/3, Ground floor, Mayapuri Industrial Wipes for Disinfection/Cleaning of designed to rapidly clean and disinfect areas at great risk regulated 23-02-2016
Area, Phase-I, New Delhi-110064 medical devices
22 29/misc/3/2016-DC(45) M/s Ceragem India Pvt Ltd., 4th Floor, Plot no.58,Sector-44, HUDA, Ceragem RL1 (ceragem master v3) automatic thermal masager Not regulated 23-02-2016
gurgaon, haryana-122002
23 29/misc/3/2016-DC(29) M/s Becton Dickinson India Pvt ltd., 5th Floor, Signature tower B, South BD CS&T beads for in-vitro to be used to monitor daily instrument performance by measuring fluorescence regulated 23-02-2016
city I, Gurgaon-122001, Haryana diagnostic (Qulaity control solution) sensitivity and alignment.24 29/misc/03/2013-DC(281) Shri. Om prakash, Section officer, Ministry of Heatlh and family welfare, Left Ventricular Assist devices used to partially or completely replace the function of a failing heart-used as a Not regulated 18-02-2016
Nirman Bhwan, New Dlehi bridge to transplant to keep the patients alive till an organ can be found
25 29/misc/3/2016-DC(55) M/s Utanco India 13, Tarun Encalve, near Pushpanjali Pitam Pura, Delhi- Green cast orthopaedic artificial limbs use in he construction of orthopaedic casts, temporary immobilization of regulated 01-03-2016
110034 making tape fractures, sprains and strains
26 29/misc/3/2016-DC(54) M/s Peches Lifestyles Pvt LTd., 1, dhanvantri, Rambaug lane opp, Mulji Cryo Slim 2HPS, Oxygen & Water used for cosmetic purpose Not regulated 1/3/2016
Nagar, off S.V Road, Borivali(West), Mumbai-400092 peel Plus LED system Potable ware
LED and I-Frax Non-Invasie Radio
Frequency Aesthetic system
27 29/misc/3/2016-DC(43) M/s Covidien Healthcare india Private limited 4th Floor, Tower A &B, SAS ligasure curved small jaw open Used for general surgical procedures where ligation and division of vessels(up to regulated 1/3/2016
tower medanta The medicity complex, sector-38, Gurgaon, Haryana-122001sealer/Divider 7 mm in diameter) tissue bundies and lymphatics
28 29/misc/3/2015-DC(249) M/s Merck Limited, Shiv sagar Estate, A dr. A.b Road, worli Mumbai- Vented Medical Milex filter in India vented millex-GV filter units are syringe filters used for sterilization of low Not regulated 11/3/2016
400018 volume aqueous solutions for direct patient injection, filtration of laboratory
solutions, and filtration of clinical solutions where venting and low protein
binding membrance are required
29 29/misc/3/2015-DC(146) M/s. Agkem Impex pvt Ltd., 503-504, Rishabh corporate tower, Plot No.16, Zlrconia Blank, Vintage ceramage indicatef ofr vennering of metal framework and copings for the Not regulated 22-03-2016
community centre karkadooma, Delhi-110092 Art/Hole/MP/ZR/Al, ceramage preparation crowns and bridges
30 29/misc/3/2016-DC(64) Chief Medcial Officer, Office of CMO, Sawai maan Singh Hospital Jaipur, Heart valves nil regulated 22-03-2016
Rajasthan-302004
31 29/misc/03/2016-DC(72) M/s Greiner Bio-One(india) Pvt Ltd., the corenthum, 2111, tower-A, Plot Lancet nil Not regulated 22-03-2016
no.A/41, Sector-62, Noida-201301
32 29/misc/3/2016-DC915) M/s Shakhti Knitting limited Land Marvel Nest F-1,3 first Main Road, Bedsheet & other articles containing bed sheets, pillow covers, pillows 7 mattresses ,Hospital scrubs, Masks, doctor Not regulated 22-03-2016
indira nagar Adyar, Chennai-600020 chemical salts for home & hospitals coats, lab coats, patient care gowns, Kitchen aprons, table cloth,Napkins &
uses Towels, Kerchiefs, mittens & gloves, socks, and other article made out of
textiletreated with chemical i.e (Dimethyltetradecy193-trimethoxysily) propy)
ammoniumchloride, a quaternary ammonium salt(QAS) to be used in hopsitals,
patient care homehotels and residence
33 29/misc/3/2016-DC(63) M/s Surgiplus, Polt No.2,5th Cross, Ganaprakasam nagar, Puducherry- Connecting tube with & without nil regulated 22-03-2016
605008 yankuer
34 29/misc/3/2016-DC(83) M/s Covidien Healthcare india Private limited 4th Floor, Tower A &B, SAS Pledgets and trocar PTFE Polymer pledgets and versaport/Versaport plus bladeless tocar-sutuer and regulated 22-03-2016
tower medanta The medicity complex, sector-38, Gurgaon, Haryana-122001 catheter
35 29/misc/03/2016-DC(75) M/s Ace Cardiopathy Solutions Pvt LTd., 704,7th Floor, Kirshna apr Comfort-In (needle-Fress & easy- contains syringes and adapter used to deliver 0.5ml volumes of various regulated 11/4/2016
Business Square, neata Ji Subhash Place, Delhi-110034 Quick Inection system) medications(especially insulin) and vaccines subcutaneoulsy36 29/misc/3/2016-DC(93) M/s Covidien Healthcare india Private limited 4th Floor, Tower A &B, SAS PDB(Preperitoneal Dissection balloon) indicated for patients undergoing laparoscopic surgery requiring tisue separation regulated 5/4/2016
tower medanta The medicity complex, sector-38, Gurgaon, Haryana-122001kindney and round shaps balloon of the extraperitoneal space
37 29/msic/3/2016-DC(92) M/s Covidien Healthcare india Private limited 4th Floor, Tower A &B, SAS chronic catheter accessory used to aid peructaneous insertion of peritoneal regulated 5/4/2016
tower medanta The medicity complex, sector-38, Gurgaon, Haryana-122001
38 29/misc/03/2016-DC(80) M/s B l Health 7 Safety pvt ltd., BL House & Safety pvt ltd., New Delhi- Waterjel fire Blankets and Dressing for indicated to cool and soothes both minor burns and moreserious burns Not regulated 5/4/2016
11049 burns
39 29/misc/03/2016-DC(88) M/s Covidien Healthcare india Private limited 4th Floor, Tower A &B, SAS Y-connectors used for guiding, positioning and locking guidewires or catheters regulated 5/4/2016
tower medanta The medicity complex, sector-38, Gurgaon, Haryana-122001
40 29/misc/03/2016-DC(84) Dr. Shahid Ali Siddiqui, MBBS MD, prof & head, Department of radio- LED based light source device-LED trestment i Not regulated 5/4/2016
therapy J.n Medical College & Hospital, Aliderh Muslim University, based intraoral PDT light deliver
Aligarh-202002 system used for PDT(photodynamic
therapy)
41 29/misc/03/2016-DC(81) M/s Sarvam Safety equipment Pvt Ltd., L-11, SIDCO Industrial estate Waterjel blankets Indicated to cool and soothes both minor burns and more serious burns Not regulated 5/4/2016
Villivakkam, Chennai-600049
42 29/misc/03/2016-DC(42) M/s Unor Exim Pvt ltd., 403 Kirti Mhal bulding, 19, Rajendra Place, new PVA Nasal packs/PVA Naal tampons, intended for controlling nasal hemorrhage, Septoplasty, rhinoplasty and intro- regulated 12/4/2016
delhi-110008 Invotec internal Nasal Splint & nasal surgical
ventilation tube
43 29/misc/3/2016-DC(101) M/s Unicorn Denmart Ltd., 3, Local Shopping centre, Mor land Near, J Dental Material used as dental restorative material for veneering of metal framework and opings Not regulated 12/4/2016
Block, DDA market near ranjendra Nagar, New Delhi-110060 for preparation crowns and bridges
44 29/misc/03/2016-DC(94) M/s Sahotaz, 214C/2 Guatam nagar, New Delhi-110049 Silky cup(reusable Menstrual Cup) used to collect menstrual fluid during menstruation as a viable alternative to Not regulated 12/4/2016
sanitary nakings, cloth pads and tampons
45 29/misc/03/2016-DC(96) M/s Event medi Systems, 218, vishal tower, District centre, Janakpuri, New Manifold manifold inteded for flow control and as delivery devices for I.v fluids injection regulated 12/4/2016
Delhi-110058 in angiographic procedures
46 29/misc/3/2016-DC(08) M/s Hindustan medi-needs flat no.2132, Sector-D, Pocket-2, Vasant Kunj, disposable swabs disposable swabs containing one pad satuated with 70% isopropyl alcohol, regulated 19-04-2016
part-I New Delhi-110070 intended for leaning the skin at the site of injection before giving the injection
47 29/misc/3/2016-DC(100) M/s Unicorn Denmart Ltd., 3, Local Shopping centre, Mor land Near, J Prime Dental VLC(Hydrid Composit used as filler/Restorative material for dental cavities Not regulated 21-04-2016
Block, DDA market near ranjendra Nagar, New Delhi-110060 kit, Nano-hybrid composite kit,
flowable Kit, Enamal bond adhesive)48 29/misc/3/2016-DC(113) M/s S. Three Sales International pvt Ltd., M10, Old DLF Market, Sector Clave needle free connector intended for use as an accessory to intravascular adminstration set for the regulated 25-04-2016
14, Gugaon aminstration of fluids to patient through a cannula placed in the vein or artery
49 29/mics/3/2016-DC9103) M/s Mitra Medical Services LLP, B-226, Okhla Industrial Area, phase-1, Wave guidewire wave guidewire intended to be used as an accessory for endoscopes regulated 26-04-2016
new Dlehi-110020
50 29/misc/03/2016-DC(89) M/s Covidien Healthcare india Private limited 4th Floor, Tower A &B, SAS Auto Suture Surgiwand used in laproscopic procedures as a multi-purpose operating tool with irrigation regulated 26-04-2016
tower medanta The medicity complex, sector-38, Gurgaon, Haryana-122001 and suction capabilities
51 29/misc/03/2016-DC(87) M/s Covidien Healthcare india Private limited 4th Floor, Tower A &B, SAS LF-1212 Ligasure curved small jaw intended to be used with the force triad energy platform Not regulated 28-04-2016
tower medanta The medicity complex, sector-38, Gurgaon, Haryana-122001open sealer/divider is a bipolar
electrosurgical instrument
52 29/misc/03/2016-DC(86) M/s Covidien Healthcare india Private limited 4th Floor, Tower A &B, SAS Endo catch Gold used for safe, Convenient removal of tissue specimens such as the appendix, and Not regulated 4/5/2016
tower medanta The medicity complex, sector-38, Gurgaon, Haryana-122001 ectopic pregnancy, gall bladder, gal stones, lymph nodes, ovaries, small sectons
of bowel and other tissues structures
53 29/misc/03/2016-DC(90) M/s Covidien Healthcare india Private limited 4th Floor, Tower A &B, SAS Endo bag Specimen retrieval system intended for use in laproscopic procedures where removal of tissue or debris Not regulated 4/5/2016
tower medanta The medicity complex, sector-38, Gurgaon, Haryana-122001 from the abdominal cavity is desired
54 29/misc/3/2016-DC(122) M/s edwards Lifesciences(India) private Limited E.F 201-204, remi Disposable pressure transducer; model disposable pressure transducer Model No. PX 260 used to measure arterial regulated 4/5/2016
bizcourt, Plot No.9 shah industrial estate, off veera desai road andheri(w), no. PX 260 pressure or central venous pressur in human beings
Mumbai-400058
55 29/misc/3/2016-DC(99) Dr. Sayan Basu, Member secretary ethics Committee LV prasad eye RHCIII-MC Bio-Synthetic cornea in nil Not regulated 4/5/2016
institute banjara hills Hyderabad-500034 patients requiring deep anterior lamelar
keratoplasty(DALK)
56 29/misc/3/2016-DC(130) M/s Peches Lifestyles Pvt LTd., 1, dhanvantri, Rambaug lane opp, Mulji Medical equipments for cosmetics used for cosmetic purpose not regulated 4/8/2016
Nagar, off S.V Road, Borivali(West), Mumbai-400092 tratment(AML1,2,3,4,5,6,7,8)
57 29/misc/3/2016-DC(125) M/s Kay & company, 25, netaji Subhaseh marg, new delhi-110002 medical equipments surgical nil Not regulated 4/5/2016
instrument and hospital rubber goods
58 29/misc/03/2016-DC(124) M/s Chrysalis Healthcare Private Limited, A-5, Golf View Apartment saket, MiniMizer gastric Ring Insicatef for sustain 7 effective weight loss in bariatirc surgery Not regulated 10/5/2016
New Delhi
59 29/misc/03/2016-DC962) M/s cliniRx tangent Research Private Limited patriot House, 4th Floor 3, Minimally Invasive Micro intended for the reduction of elevated intraocular pressure(IOP) Not regulated 10/5/2016
bhadur Shah Zafar marg, New Dlehi-110002 Sclerostomy(MIMS)60 29/misc/3/2015-DC(133) M/s Helico International, Unit 2, C-30, KSSIDC Industrial Area, Poly urethane fam dressing kit drain the chronic wounds such as diabetic foot ulcers, pressure sores etc regulated 10/5/2016
doddaballapura-561203, bangalore rural
61 29/misc/03/2016-DC(131) M/s Duraent Biologicals Ltds., T & a 12A, 2nd Floor, Jain enclave T & A Eurocollins A, eurocollins B, Servator used for the flushing and cold storage of organs like heart lung kidneys, liver and not regulated 10/5/2016
Plaza < Madhapur, Sharlingampalli Mandal, ranga reddy dist hyderabad- HTK, Servator c and Servator P) panceras
500081
62 29/misc/03/2016-DC(121) M/s. Concord Drugs Limited 3-11-1/1, opp Kamineni Hospital, L. B . Amcrylate Bio-Adhesive -Amyl 2- intended to be used as bio-adhesive Not regulated 10/5/2016
Nagar, hyderabad-500074 Cyanoacrylate
63 29/misc/3/2015- M/s Accredited Consultants Pvt Ltd., D-29, First floor, Achharya Niketan, Adhesive Plaster, bandages, casting nil Regulated 10/5/2016
DC(194)(214)(225) Mayurvihar, Phase-I, New Delhi-110091 taps and splint
64 29/misc/3/2016-DC9104) M/s Mitra industries Pvt Ltd., 14/4, delhi-mathura road, faridabad Haryana-Raw material used in manufacturing of nil Not regulated 17-05-2016
121003 Blood Bags & dialysis bags
65 29/misc/3/2016-DC(104) M/s Mitra industries Pvt Ltd., 14/4, delhi-mathura road, faridabad Haryana-Polyether ether ketrone(Peek tubing used for the manufacturing of non-cardiac stents Not regulated 17-05-2016
121003 extruded), Sheath(Plastic tube) and
nitinol wire(AS brawn Biright)
66 29/misc/03/2016-DC9146) M/s Emergo(India) Conulting Pvt Ltd., H.No. 8/1, First Floor,Vasavi Endometrial curette and pipettes use of this medica deivce is endometrial biopsy and mechanical removal of the Not regulated 17-05-2016
colony, kakaguda, near Picket secunderabad, MCH Circle-7 Mandal, dumulus cell payers of the oocyte
Hyderabad-500009
67 29/misc/03/2016-DC(147) M/s Pro Medic devices., A-13 East Krishna Nagar Swami Dyanand marg, pacemaker nil Not regulated 17-05-2016
delhi-110015
68 29/misc/3/2016-DC(91) M/s Covidien Healthcare india Private limited 4th Floor, Tower A &B, SAS SILS PORT indicated for multiple instrument or camera access to the abdominal cavity Not regulated 6/6/2016
tower medanta The medicity complex, sector-38, Gurgaon, Haryana-122001 through a single incision for performing minimally invasive laparoscopic
procedures
69 29/misc/03/2016-DC(85) M/s Covidien Healthcare india Private limited 4th Floor, Tower A &B, SAS Bluntport and blunt tip trocar, used in variety of gynecologic general thoracic and urologic endoscopic regulated 6/6/2016
tower medanta The medicity complex, sector-38, Gurgaon, Haryana-122001thoracoport trocar and visiport plus procedures
optical trocar with fixation cannula
70 29/misc/3/2016-DC(167) M/s Bornlife prosthetic & orthotic ins, H-2 Near gurudwara, Lajpat nagar-I, Rehabilitation goods(prostetic hip , used for externally artificial body parts and assistive device by handicap Not regulated 9/6/2016
New Dlehi-110024 knee joint, foot, artifical limbs and its persons).
accessories, orthopedic braces &
supports, orthotic devices, silicone
products, wheel chairs,
71 29/misc/03/2016-DC(172) the drugs controller & Licensing Authroity, office of the drugs controller for Polyurethane foam dressing kit(Non- nil regulated 10/6/2016
the state of karnataka, post bag no 5377, palace road, bangalore-560001 Sterile)72 29/misc/3/2016-DC(176) M/s. Accredited consultants Pvt LTd., d-29, 1st floor, Acharya Niketan Dental impression material and mixing used as dental restorative material and dental equipments Not regulated 13-06-2016
mayur Vihar, Phase-I, Delhi-91 equipments
73 29/misc/03/2016-DC(177) M/s Medsurgelnd private limited New No.7, old no.4, I cross Street Surgical Disposable product(Plastibell used during surgery not regulated 13-06-2016
Shashthri nagar, Adyar, chennai-600020 amni hook umbilical cord clamp, Urine
bag
74 29/misc/3/2016-DC(164) M/s Cybernoid healthcare pvt Ltd., Plot No.70, First Layout, teachers Robotic exoskeleton used to mobilize patients of spinal injury with bilateral lower limb parapysis Not regulated 14-06-2016
colony, Kolathur Chennai-600099 orthosis(Cybolimb)
75 29/misc/03/2016-DC(191) M/s Maser Electronics Pvt Ltd.,76, Vishal Industrial estate, opp CEAT Airborne ultrasound-GlybetaC glybetac aerostimulator utilizes in the ultrasound energy to improve and enhance Not regulated 14-06-2016
Tyres, Bhandup(W), Mumbai-400078, india Aerostimulator the cel permeability and help in the transportation of drugs
76 29/misc/03/2016-DC(187) M/s St.Luke Med devices pvt Ltd., ISHI Land", No.18, tagore nagar 1st Prefilled Humidifier with adaptor used to humidify the respiratory gas Not regulated 14-06-2016
Street, Ayanavaram, chennai-600023
77 29/misc/03/2016-DC(182) M/s Pure tech health,pant hospital, bhua rani, Kashipur Road, Rudrapur, Movas-Electric potential therapy nil Not regulated 14-06-2016
Uttarakhand-248197 equipment
78 29/misc/3/2016-C(165) M/s Unistar tools and engineering, 208, plot no.14, gupta Arcade. Maypuri Orthopaedic saw blades used for bone surgery(for ctting) Not regulated 14-06-2016
indl area Phase-II, new Delhi-64
79 29/misc/3/2016-DC(129) M/s encarta Pharma Pvt ltd., Shristi No. 21 3rd floor, 24th Main Road JP Hyper-CL contact Lens for corneal dystrophies Not regulated 14-06-2016
Nagar 6th Phase, Bangalore-78
80 29/misc/03/2016-DC(175) M/s Raj Agencies, Shop No.58, ganesh Plaza, (4th floor) No.3, nyniappa Nebulizer mask, Oxygen masj, Nasal nil Not regulated 14-06-2016
nicken street, chennai-600003 cannula and circuit
81 29/misc/03/2016-DC(174) M/s hi-tech Advance products, P-27, Sukhlia ,Near bapat Nursing Home, Syringe and needles for veterinary use DAN-Inject injection needles b) DAN-inject Dart Syringes c), DAN-Inject regulated 14-06-2016
indore-10(MP) blowpipe systems and d) DAN-Inject carry and handling system-Model Rug
used for treatment of wild and Zoo animals
82 29/misc/03/2016-DC(186) M/s Becton Dickinson India Pvt ltd., 5th Floor, Signature tower B, South BD Odon Device for assisted vaginal intended to assist skilled attendant in vaginal delivery Not regulated 14-06-2016
city I, Gurgaon-122001, Haryana delivery
83 29/misc/03/2016-DC9170) M/s Accredited Consultants Pvt Ltd., D-29, First floor, Achharya Niketan, ECG recorder & tansmitter mfd used as ECG Recorder & Transmitter not regulated 14-06-2016
Mayurvihar, Phase-I, New Delhi-11009184 29/misc/03/2016-DC9155) M/s Indo-US Supersoeciality hospital, A unit on nano hospital pvt ltd., # 7- hyath cancer Annihilation machine for used in cancer treatment Not regulated 15-06-2016
1-57 B&C, Shyam karan road, Anand Bagh, Ameerpet, Hyderbad-500016 cancer treatment
85 29/misc/03/2016-DC(169) M/s MN Solutions, space No.512, 5th Floor Shahpuri tirath Singh Tower Acrylic teeth-goldent classic acrylc used in prosthetic dentures Not regulated 15-06-2016
Plot No.58, block-C, DDA community Centre, janakpuri, New Dlehi- teeth
110058
86 29/misc/03/2016-DC(189) M/s Toshbro Medical Pvt Ltd., 1001-1002, vikram tower 16 Rajendra Aneurysm clips, Drill Burrs/cutters, nil Not regulated 21-06-2016
Place, new Delhi-110008 perforators & craniotomes
87 29/misc/03/2016-DC(196) M/s goldwin Medicare Ltd., 2, Doctor house, 2nd Floor, 124 Perin Nariman Synthetic casting tape nil regulated 21-06-2016
Street, fort Mumbai-400001
88 29/misc/3/2016-DC(198) M/s. KPM Healthcare f-33, Second Floor, DSIDC Complex, near udyog Drip chamber spike luer lock/luer slip intended for manufacturing of finshed medical devices Not regulated 24-06-2016
nagar Metro Station, rohtal road, Delhi-110041 connector, tube roller clamp and flow
regulator) pU/PE/ silicone tube 3) PU
spiral/Straight tube, Male /female luer
lock connector4) male/female luer
lock, parallel connector 5) needle free
valve
89 4-MD/CT-131/2015-DC M/s Alfa corpuscles Private Limited 25/36, East patel Nagar New Dlehi- Enject safety syringe Clinical trial in respect of prodct i.e. enject safety syrine regulated 9/6/2016
110008
90 29/misc/3/2015-DC(258) M/s KCI Medical india Pvt ltd., no.1, Ramachandra Comple, 1st floor, 1st V.A.C Verlink installation casette disposable component to be used with VAC ulta wound therapy system Not regulated 22-06-2016
Cross M.S Nagar Opp Ayappa temple, banglore-560033
91 29/misc/03/2016-DC(173) M/s Shield Healthcare Pvt Ltd., AVN complex, vanagram Serivce Road, Biguanelle and andrositol lab biguanelle(hydroxyethyl cellulose+ lactic acid+ glycerol+ KCI+Sodium edetate+ regulated 30-06-2016
Vanagaram, Maduravoyal, Chennai-600095 PHMB) use for the treatment of vulvovaginitis and cervicovaginitis and
andrositol lab (Myo-inositol+ Naci) used for the treatment of mae seminal fluid
92 29/misc/03/2016-DC(195) M/s Hindustan syringes & Medical devices Ltd., GL-3, Ashoka estate, 24, evacuated Blood collection tube Evacuated blood collection tube without needle Not regulated 1/7/2016
barakhamba raod, New Dlehi-110001
93 29/misc/3/2016-DC(132) M/s Halyard health India Pvt ltd., world trade Centre tower-1, unit-308, Integuseal Microbial Sealant which a intended for use after typical pre operative skin preparation regulated 11/7/2016
Kharadi, Pune-411014 cyanoacrylate
94 29/misc/03/2016-DC9204) M/s Vygon India Pvt ltd., B-17, infocity, Section -34, gurgaon- a) Endotracheal tube nil a), b) c) - regulated 12/7/2016
122001(Haryana) b) Feeding tube and
c) Swivel connector d), e) Not regulated
d) urine collection bag,
e) Filters95 29/misc/3/2016-DC(21) M/s cytocare technologies Pvt Ltd., Hyderabad Cryomacs Freezing bags transfer sets intended for storage of peripheral Blood Stem cells and cord bloocd stem cells regulated 15-07-2016
and clinimacs reagents
96 29/misc/03/2016-DC(179) M/s Regency Lifesciences India Pvt Ltd., No.8, 4th A Cross, 5th Main, New gel+(Silicone gel +vitamin E gel) used in management of hypertrophic and /or scars regulated 19-07-2016
HRBR 2nd Block, Kalyan Nagar, bangalore-560043
97 29/misc/03/2016-DC(178) m/s Feron life Sciences(P) Ltd., B-1, yadav park, Main Rohtak road, Hemoperfusion Cartridge and intended for removal of bulirubin and bile acids regulated 19-07-2016
Opp,Metro Pillar No. 436, nangloi, Delhi-110041(india) dispobale plasma billrubin perfusion
Adsorption column
98 29/misc/03/2016-DC(157) M/s Mod Medicare Systems Pvt Ltd., GH-2/81-B, Paschim Vihar, New Smart site with small bore extension nil regulated 19-07-2016
Delhi-110063 set, y extension set with two smartsite
and tri-port extn set with two smartsite
and c) tri-port wxtn . Set with 3 smart
site)
99 29/misc/03/2016-DC(171) M/s Allergan India Private Limited Level 2, Prestige Obelisk, No.3 Glaucoma gel implant Xen 45(Xen gel used to reduce IOP in patients with primary open angle glaucoma (POAG) regulated 19-07-2016
Kasturba Road, Bangalore-560001 implants)
100 29/misc/03/2016-DC9207) m/s Aakaar Medical technologies Pvt Ltd., A-801, heritage Plaza, telli Galli Hairstetics hair implant to treat alopecia not regulated 19-07-2016
Cross Road, Andheri(E), Mumbai-400069
101 29/misc/03/2016-DC(219) M/s ventura business Solutions, 109/13, First floor, amritpuri-B, Opp iskon Wound healing system used to heal chronic ulcers, reduce lesion size and wound pain and accelerate Not regulated 22-07-2016
temple, east of kailash, New Delhi-110065 tissu re-growth
102 29/misc/03/2016-DC(224) M/s Sesderma India Pvt lTd., 6/1517 Devika tower -6 Nehru Place, New Nanopore stylus used for aesthetic/Cosmetic application of the skin Not regulated 22-07-2016
Delhi-110019
103 29/misc/03/2016-DC(222) M/s live2give international Marketing pvt ltd., Industrial area, plot no.E- Anti-Snore products used to help prevent snoring and facilitate breathing and hongseng callus Not regulated 22-07-2016
216, Focal point Phase 8-B, Mohali-160058 Punjab remover for removing dead skin
104 29/misc/03/2016-DC(138) M/s halyard heatlh inida pvt ltd., World trade center, tower-1, Unit-308, oral care products oral care products Halyard Yankauer, halyard suction handle, Halyard oral care Not regulated 22-07-2016
Kharadi, Pune-411014 swab and halyard oral care suction toothbrush
105 29/misc/03/2016-DC(226) M/s Accredited Consultants Pvt Ltd., D-29, First floor, Achharya Niketan, Universal (UNI) handle(ICV0664) and used as accessory instruments I hear valve replacement surgeries Not regulated 22-07-2016
Mayurvihar, Phase-I, New Delhi-110091 holder handle(P0593)
106 29/misc/03/2016-DC(162) M/s BD India Pvt ltd., 204, Tolstoy house, 15, tolstoy marg, new delhi- PleurX Catheter System-drainage kit , nil regulated 22-07-2016
110001 pleurX procedure pack & plexurX
lockable drainage line kit consisting of
self-adhesive dressing and Alcohol
pads107 29/misc/03/2016-DC(227) M/s Lifesol Medical private ltd., Okhla Phase-2, New Delhi Lifesol neutraflow single with non single use disposable device intended for the withdrawal of fluids continuous or regulated 26-07-2016
DEHP extension line internittent administration of fluids
108 29/misc/3/2016-DC(218) M/s Aramex Trading co., 9-Ashok Nagar, Lucknow Dental material Ahfil used as dental restorative material Not regulated 2/8/2016
109 29/misc/03/2016-DC(08) M/s J. Mitra & Bros., P.O Box-2809, 20 Double storey market, New Euroset Mini Arterial filter used in pediatric open heart surgeries in childern surffering from heart diseases Not regulated 4/8/2016
Part-I Rajendra Nagar, New Delhi-110060
110 29/misc/03/2016-DC(180) M/s Maquet Medical India Pvt Ltd., II floor, Mehta Trade Centre" No.1, Vasoview & Endoscopic vessel used for minimal invasive surgery Not regulated 8/8/2016
shivaji Colony, Sir M.V. Road Andheri(E), Mumbai-400099 Harvesting System, Vasoview
Hemopore 2 Endoscopic Vessel
harvesting and 7mm Endoscope
111 29/misc/03/2016-DC(83) M/s covidien Healthcare India Pvt Ltd., 4th Floor, Tower A & B, SAS trocar nil regulated 8/8/2016
tower, medanta the medicity complex, Sector-38, Gurgaon-1220011
112 29/misc/3/2016-DC(253) Dr. Haresh Bhalodiya Principal Investigator Saviour Multispeciality freedom total knee system in total knee surgeons want to conduct the study on a retrospective cohort of the patients approval 9/8/2016
hospital, near bhart petro pump, near lakhudi talaw, stadium road, arthroplasty operated by the surgeon in the year 2010-11
navrangpura, Ahmedabad-380014
113 29/misc/03/2016-DC(126) M/s Event medi Systems, 218, vishal tower, District centre, Janakpuri, New Balloon inflation device(indeflator) and nil Regulated 9/8/2016
Delhi-110058 Haemsotiatic valve kit(Y connector
Kit)
114 29/misc/03/2016-DC(239) M/s Scitra International No.5, Sillco valley, Sector-127 S.A.S Nagar, Soft cast Bandage used under POP bandage to give cushioning effect to the patient Not regulated 11/8/2016
Punjab-140301
115 29/misc/03/2016-DC(235) M/s Zuventus healthcare ltd., T-184, MIDC, Bhosari, Pune-411026 SiGyn vaginal gel used for vaginal symptoms in Genitourinary Syndrome during menopause(GSM) regulated 18-08-2016
116 29/misc/03/2016-DC(215) M/s Morulaa health tech Pvt Ltd., Plot no.38, first floor, rajeswari Street, Megadyne Medical product used during general and laproscopic surgical procedures Not regulated 18-08-2016
Santhosh Nagar, Kandanchavdi, Chennai-600096
117 29/misc/03/2016-DC(225) M/s Vasu vaccine & Speciality Drugs, Vasu's Pharma House, 3-6-516/4, Rxvoice, Rxtunnel and Rxnasalve for ENT application regulated 23-08-2016
5th Floor, Street No.6, himayatnagar, MCH Cirlce-3, mandal, Hyderabad-
500029
118 CLAA/MD/HR/01/2015- M/s prymax healthcare LLP, Plot no. 53/17, industrial area NIT Faridabad Disposable persfusion set Heart lung pack and angio kit including accessories viz, arterial & venous pump regulated 9/8/2016
DC haryana(India)-121001 lines, arterial filter bypass loops, Y connectors, perfusion tubing manifold etc119 29/misc/03/2016-DC(184) M/s Hollister Medical India Private Limited, Plot No.27, Sector 5, Phase-II, Benzalkonium chloride seabstick and nil NOC for the pruduct 5/9/2016
HSIIDC Growth Centre Bawal 123501, Haryana non-sterile lubricating jelly
120 29/misc/03/2016-DC(09) M/s Dhiti Biotech(India) Pvt ltd., The director, Z-29, basement Okhla Disposable infusion pumps used for self adminstration analgesic infusion regulated 6/9/2016
Industrial area, Phase II, New Dlehi-20
121 29/misc/03/2016-DC(244) M/s. Access Devices, 28, 12th cross , Indiranagar, 1st stage, Bangalore Scalp cooling system used for prevention of chemotherapy induced alopecia not regulated 12/9/2016
560038
122 29/misc/03/2016-DC(254) M/s. Lotus Surgical Pvt. Ltd., Khasra No. 105/1 & 2, Twin Industrial Absorbable Hemostat-Sterilized used adujunctively in surgical procedures to assist in the control of capillary, regulated 12/9/2016
Estate, Selaqui, Dehradun-248197 Oxidized Regenerated Cellulose venous and small arterial hemorrhage when ligation or other conventional
(ORC) USP methods of cotrol are impractical or ineffective and disposable circular stapler
intended for the creation of end to end, end to side and side to side anastomosis
in both open and endoscopic surgeries throughout the alimentary tract
123 29/misc/03/2016-DC(242) M/s. Diacare Solutions, 104, Kesarinath CHS , Opp. Vijay Sales, S.V. (A) Hemodialysis Machine terminal (A) Used for cleaning hemodialysis , thermochemical disinfection, regulated 12/9/2016
Road, Goregaon (West), Mumbai-400062 disinfectant with citric acid 21% (B) used for cleaning hemodialsis, cold disinfection
(B) Hemodialysis Machine ( C) used for reprocessing dialyzers machine
Disinfectant with Peracetic acid
( C) cold Sterilant for Dialyzer
124 29/misc/03/2016-DC(216) M/s. Pyrex Exports, 114/2, Krishan Kunj, 7 Civil Lines, Roorkee-247 667 R(Ae)p Droecnetassl iMngaterial Glass Lonomer (A) Used for fixation of crown and bridges (A) not regulated 12/9/2016
cement (B) used for treatment of dry sockets, post extraction dressing (B) regulated
(B) Alvo Dough which is a dental
haemostatic materila having
antimicrobial action due to presence
125 29/misc/03/2016-DC(246) M/s. Transcath Therapeutics LLP, 1203, Mars, Rajhans Campus, Opp. o(Af )lo PdloeuforromTalc (A) used for chemical pleurodesis, malignant pleural effusion, spontaneous regulated 12/9/2016
Rajhans Multiplex, Pal-Hazira Road, Surat - 395009, Gujarat (B) embolus PVA embolization pneumothorax and
particles (B) embolus PVA embolization particles used for embolization of peripheral
hypervascular tumors including leiomyoma uteri and peripheral arteriovenous
malformations (AVMs )
126 29/misc/03/2015-DC(204) M/s. UE Life Sciences India Pvt. Ltd., A-102 Universal Paradise, Nanda iBreast Exam which is a breast lesion documentation system Not regulated 12/9/2016
Patkar Road, Vile Parle (East, Mumbai-400057
127 Import/Misc./78/2016-DC The Assistant Drugs Controller (I), room No. 10, International Air-Cargo- Radiopharmaceuticals / Radio- regulated 12/9/2016
Complex, Sahar, andheri, Mumbai-400099 Immuno assays kits
128 29/misc/03/2015-DC(30) M/s. Gale Overseas Trading Pvt. Ltd., Gale House, 5NH/87, NIT, Quease EASE is indicated for the tratment of chemotherapy induced nausea and vomiting and regulated 15-9-2016
(A) Faridabad-121001 administered through inhalation
129 29/misc/03/2015-DC(221) M/s. Accredited consultants Pvt LTd., d-29, 1st floor, Acharya Niketan Bite Registration Materials and used for dental impression Not regulated 15-09-2016
mayur Vihar, Phase-I, Delhi-91 impression materials
130 29/misc/03/2015-DC(242) Shri S K Bhandari, Brig. DDCDS ( E & S), Dte. Gen of Dental Services, COE-PAK Automix -Periodontal is a two component material for wound dressing to cover stitches or to stabilize regulated 19-09-2016
Adjutant General's Branch IHQ of MoD (Army), L Block, new Delhi - dressing loose teeth. Wound dressings
110002131 29/misc/03/2015-DC(261) M/s. BSN Medical Pvt. Ltd., B-10, Lotus Park, Jai Coach Junction, Opp. JOBST Compri2 and JOBST Compri2 intended for compression treatment of venous leg ulcers and any accompnying regulated 26-09-2016
Raheja Ridgewood, Jogeshwari (East) Mumbai-400063 Lite oedemas and the copression treatment of lymphatic oedemas
132 29/misc/03/2016-DC(09) M/s. Dhiti Biotech (india) Pvt. Ltd., Mr. Anand sekhari, c-59/1, okhla Disposable infusion pumps consisting of reservoir, PVC tubing, ABS Tubing connector, which is a sterile regulated 26-09-2016
Industrial Area, Phase -II, New Delhi-110020 disposable single use device intended for administration of analgesic in therapy
of chronic pains to the patients
133 29/misc/03/2016-DC(83) all port offices of cdsco Trocars Trocars are regulated under the "Catheters" regulated 26-09-2016
134 29/misc/03/2016-DC(257) Alleen Clinical Research Services, Dr. Sudhakar Bangera, G-5 Mount Meru CoAg Stop Bleeding Topical Hemostat intended for use as topical dressings for the management of bleeding wounds regulated 26-09-2016
Road No. 5, Banjura Hills, Hyderabad-500034 powder and foam
135 29/misc/03/2016-DC(138) M/s. Halyard Health India Pvt. Ltd., World Trade Centre, Tower-1, Unit- Halyard connection tubing with suction intended for removal of oral and nasal secretion from mouth and nose regulated 27-09-2016
308, Kharadi, Pune - 411014 valve
136 29/misc/03/2016-DC(245) M/s. ConvaTech India Pvt. Ltd., S-604, 6th Floor, World Trade Centre, "Abviser Autovalve" consisting of used fro monitoring intra-abdominal pressure (IAP) regulated 13-10-2016
Brigade Gateway, Yshwantpur, Bengaluru -560055 syringe and infusion tube
137 29/misc/03/2016-DC(128) M/s. ConvaTech India Pvt. Ltd., S-604, 6th Floor, World Trade Centre, Ostomy bags and wafers used for collection of waste from surgical dicerted biological system (colon, Not regulated 13-10-2016
Brigade Gateway, Yshwantpur, Bengaluru -560055 ileum, urinary ) and certain of stoma
138 29/misc/03/2016-DC(75) M/s. ACE Cardiopathy solutions pvt. Ltd., 704, 7th Floor, Krishna Apra Comfort-In™ (Needle-Free & Easy- used to deliver 0.5 ml volumes of various medications (especially insulin) and regulated 13-10-2016
Business Square, neta Ji Subhash Palace, Delhi-110034 quick Injection System)" contains vaccines subcutaneously
syringes and adapter
139 29/misc/03/2016-DC(232) M/s. Ventura Business Solutions, 109/13/First Floor, Amritpuri-B, Opp (A) G-EYE Endoscopy consisting of G-(A) intended for increased diagnostic yield durign colonoscopy, endoscope (A) not regulated 14-10-2016
Iskon Temple, East of Kailash, New Delhi-110065 EYE Balloon Kit & NaviAid stabilization during therapy and extended operation range in the colon, small (B) regulated
Spark/Spark2C inflation or deflation bowel and entire GI tract
unit (B) intended for deep ileoscopy / upper enteroscopy and colonoscopy
(B) NaviAid AB & ABC Balloon
140 29/misc/03/2016-DC(285) M/s. Kanam Latex Industries Pvt. Ltd., Ooppoottil Building, K.K. Road, eSnudrogsiccaolp Se tienrtielen dGeldo vfoers d/ eNepo ni lSeotesrciolep y not covered under the 19-10-2016
Kottayam-686001 Surgical Gloves and medical provisions of D7C act
examination gloves141 29/misc/03/2016-DC(08) The Additional Commissioner, Air Cargo Complex, Office of the principal "Disposable Hypodermic Needles" are it is clarified that any device which is :- regulated 19-10-2016
Part III commissioner of customs, new custom house, Meenambakkam, chennai- notified as drugs vide G.S.R. 356 (E) 1. disposable after its first use and
600027 dt. 17-03-1989 under the clause (IV) 2. penetrate through th hypodermis ( The innermost and thckest layer of the
of sub-section (b) of section 3 of the D skin) for its operation and
& C Act 3. intended for the purpose of injecting fluids into, or withdraw fluids from,
parts of the body
The device , bone marrow harvest needle is a single-use harvesting needle
comprised of a stainless steel cannula with a molded plastic handle and a
stainless steeel stylet with a molded plastic handle. it is designed for allogenic
and autologous bone marrow harvesting transplantation procedures. It is places
through the skin into the marrow cavity, where stem cells and blood are
aspirated.
142 29/misc/03/2016-DC(150) M/s. Zuventus Healthcare Ltd., T-184, M.I.D.C., Bhosari Pune-411026, Moco-peg intended as an oral gardle for management of dry mouth i.e. in xerostomia which regulated 25-10-2016
india occurs after radiation and chemotherapy in cancer patients
143 29/misc/03/2016-DC(254) M/s. Lotus Surgical Pvt. Ltd., Khasra No. 105/1 & 2, Twin Industrial single use Hemorrhoidal stapler used in hemorrhoids and suturing of intrarectal invaginate regulated 25-10-2016
Estate, Selaqui, Dehradun-248197
144 29/misc/03/2016-DC(255) The Assistant Drugs Controller (I), Jawaharlal Nehru Port Trust CFS PU Iodine incise drape used for string adhesion and continuous broad spectrum antimicrobial activity at regulated 25-10-2016
(Imports), Nava Sheva, Navi Mumbai-400707 the surgical site
145 29/misc/03/2016-DC(276) M/s. Nice Enterprises, New No. 21 (Old No. 12) S1, Rajeshwari Street, (a) PU Iodine incise drape (a) used for string adhesion and continuous broad spectrum antimicrobial (a) regulated 25-10-2016
Mehtanagar, Chennai-600029 (b) PTFE Coated Non Stick Tip activity at the surgical site (b) non regulated
Cautery Pencil (b) indicated to remove tissue and control bleedign by use of high frequency
electric current during electrosurgical process
146 29/misc/03/2016-DC(208) M/s. Unor Exim Pvt. Ltd., 403, Kirti Mahal Building, 19, Rajendra Place Glycosorb®-ABO Column intended for the specific reduction of anti-A, anti-B and both anti_A and anti-B regulated 7/11/2016
New Delhi_110008 antibodies, respectively, in plasma to facilitate transplants acroos the blood
group barrier is regulated
147 29/misc/03/2016-DC(282) M/s. Meril Endosurgery Pvt. Ltd., Survey No. 135/2/B, & 174/2, 3rd Floor, Mesh Fixation Device Intended for the approximation of soft tissue and fixation of surgical mesh to regulated 7/11/2016
, E1-E3, Meril Park, muktanand Marg, Chala, Vapi, Dist. Valsad - 396191 tissues during open or laparoscopic surgical procedures, such as hernia repair
148 29/misc/03/2016-DC(253) M/s. Hetero Healthcare Ltd., Sy. No. 80-8, Melange Tower, 4th floor, C mix.jet (integrated transfer device for drug reconstitution and injection) regulated 7/11/2016
wing, Patrikanagar, Madhavpur, hyderabad, Telengana
149 29/misc/03/2016-DC(287) M/s. Essintra Life LLP, No. 32/2, Soundra Rajan Street, T. Nagar, Chennai-Organ Preservative solution - used for flushing and cold storage of organs like heart, Lungs, Kidney, liver and Not regulated 7/11/2016
600017, Tamil Nadu Eurocollins A & Eurollins B, Servator pancreas at the time of removal from donor in preparaton for storage,
HTK, Servator C, Servator P, Servator transportation and eventual transplantation in to the recipient are not notified
B, and Servator B Plus
150 29/misc/03/2016-DC(243) M/s. Aramex Trading Co., 9 - Ashok Nagar, Lucknow- 226001 a) Pericem (Dental cement without a) act as physical barrier to the healing tissues at the surgical site a) regulated 16-11-2016
Eugenol)
b) used in pulp capping and as protective liner b) not regulated
b) Hydcal151 29/misc/03/2016-DC(304) M/s. Goldwin Medicare Litd., 101/102 vailankanni towers, A wing, Mari Trancutaneous electrical nerve inteded for symptomatic relief and management of chronic , intractable pain, and Not regulated 29-11-2016
Nagar Off., Senapati Bapat Marg, Mahim (W), Mumbai - 400016 stimulation device, magnetic field adjuctive treatment in the management of post surgical and post traumatic pain
therapy device viz., pro sport, best Rsi,
Best Pro 1, Ezzi Lift
152 29/misc/03/2016-DC(285) M/s. Kanam Latex Industries Pvt. Ltd., Ooppoottil Building, K.K. Road, Surgical Sterile Gloves / Non Sterile nil Not regulated 29-11-2016
Kottayam-686001 Surgical Gloves and medical
examination gloves
153 29/misc/03/2016-DC(311) M/s. Daewoong Pharmaceutical (India) Pvt. Ltd., Plot No. 5A, APIC, IE eKare insight a camera system for capture of wound images and estimate of wound dimensions Not regulated 29-11-2016
Prashanth Nagar, Kukatpally, Hyderabad - 5000722017 Database
S. Regulatory
File . No. Name of the Company and Address Product Name Intended Use Date of Issue
NO. Status
M/s Lotus Surgicals Pvt.ltd., Khasra To be used as litigation of vessels or to
29/Misc/03/2016- Single use Titanium
1 No.1051/1 &2, Twin Industrial Estate, mark specific surgical site which Regulated 1/2/2017
DC (333) Ligating Clip
Selaqui, Dehradun-248197 would show up on the X-Ray later
to capture and or video of the cervical
region on a n andriod device using a
Veena Moktail, M/s Periwinkle
29/Misc/03/2016- Digital transvaginal transvaginal pencil camera with inbuilt
2 Technologies Pvt.Ltd., 100,NCL Not Regulated 1/2/2017
DC (316) colposcope device illumination and autofocus,connected
Innovation Park,Pashan,Pune-411008
to the anriod device via a micro-US
port
autologous blood transfusion or blood
M/s Spark Peripheral Technologies, R-
29/Misc/03/2016- product, fluid or gas via an
3 2/60,New Raj Nagar, Ghaziabad- HMT Tubing Set Regulated 1/2/2017
DC (331) extracorporeal circuit during surgery or
201002,UP
interventional treatment
Space occpying dressing, prevents
Velnez
cavity of surgery or trauma patients
M/s Datt Mediproducts Pvt.ltd.,
29/Misc/03/2016- haemostatic dressing for use in surgical
4 56,Community Centre, East of Regulated 1/2/2017
DC (327) surgeries when control of bleeding by
Kailash,New Delhi-110065 Velseal-TG
ligature, cautery or other conventional
methods are ineffective or impractical
Bone Regeneration material To be used as a graft material or graft
M/s Katara Dental, D-10/3,Okhla
29/Misc/03/2016- i.e.MineralOss Cortical and covering membrane for tissue
5 Industrial Area,Phase-1,Ground floor, Regulated 1/2/2017
DC (328) Cancellous Chips,MinerOss augmentation or growth of natural
New Delhi-110020
XP, Alloderm and Memlok bone in dental implants placement
Dr.N.Sujatha, Associate Professor, To investigate change in collagen
Dual Mode Optical Spectral
29/Misc/03/2016- Dept.of Applied Mechanics,Indian content, skin thickness and
6 Analysis System and Laser Not Regulated 1/2/2017
DC (318) Institute of Technology, IIT microvascularity in diffuse systemic
Doppler Blood Flow Meter
Madras,Chennai-600036 scleroderma patients
Bosch Mobile Non -mydriatic fundus
29/Misc/03/2016- M/s Think I,C-101,1st Floor, Sector-
7 Alogirithm(software) camera to diagnose diabetic Not Regulated 1/2/2017
DC (321) 2,Noida-201301,UP.
retinopathy using undus imagesM/s Instas Life Science Consultancy Flushing and cold storage or organs, at
29/Misc/03/2016- Pvt.ltd., 3,Green Park, Opp.Yugalkunj the time of their removal from the
8 Celsior Not Regulated 1/2/2017
DC (286) Society, B/H Prabhpark society, naroda, donor, during storage, transportation
ahmedabad-382330,Gujarat,India and transplantation into the recipient
M/s Cybernoid Healthcare Pvt.Ltd., Plot Rehabilitating spinal cord injury
29/Misc/03/2016-
9 No.70,1st Layout, Teachers Colony, Cybo Limb patients with lower limb neurological Not Regulated 1/2/2017
DC (322)
Kolathur,Cehnnai-600099 motor deficit
M/s Consumer Marketing (I) Pvt.Ltd., Prevention of injection by limiting
29/Misc/03/2016-
10 201,Dhantak Plaza, Makwana Road, Liquid Bandage exposure to dirt and germs in case of Regulated 1/10/2017
DC (346)
Marol, Andheri (East),Mumbai minor cuts, abrasions and blisters
used for removing leukocytes from
blood or red cell component to collect
Imugard III-RC or transfuse luekocyte poor red cells in
M/s Terumo Penpol Pvt.ltd., the preparation of transfusion red
29/Misc/03/2016- P.B.No.1605,I-2,Jawahar blood cells
11 Regulated 1/10/2017
DC (284) Nagar,Thriuvananthapuram-
Used for removing leukocytes from
695003,Kerala,India
platelets component to collect or
Imugard III-PL
transfuse leukocyte poor red cells in
the preparation of transfusion platelets
Bag Spike with Check
safe and easy transfer of liquid drug
Valve
29/Misc/03/2016- M/s MOD Medicare Systems Pvt.Ltd., GH- from and nto bag/bottle as a part of or
12 Bag Spike Regulated 1/10/2017
DC (157) 2/81-B,Paschim Vihar, New Delhi-110063 through syringes before administration
Smartsite needle free valve to the patients
to be used in therapy (an
electromagnetic pulse therapy) for
Antipacth chronic and acute pain due to muscle
and joint soreness,strains and
sprains,arthitis, fibromyalia
M/s Genetix Biotech Asia Pvt.ltd.,
29/Misc/03/2016- deliver medication more effectively to
13 71/1,1st floor, Shivaji Marg, Najahfarg Not Notified 1/24/2017
DC (344) Anti Static space chamber the lungs compared to pMDI
Road, New Delhi-110015
and silicon facial mask alone,anabling asthma and COPD
Patients to take control
To provide pain relief by usage of a
Paingone low frequency electrical charge
produced by crystalsM/s Goldwin Medicare Ltd.,
29/Misc/03/2016- 101/102,Vailankanni Towers, A Wing, Surgical dressing both
14 Regulated 2/14/2017
DC (304) Mari Nagar, Off.Senapati Bapat active and inactive
Marg,Mahim (W),Mumbai-400016
M/s Hansraj Nayyar Medical India, L8
29/Misc/03/2016- Vented Intubating
15 Laxmi Industrial Estate, Link Road, airway management Regulated 2/14/2017
DC (350) introducer
Oshiwara,Andheri (W),Mumbai-400053
M/s ResMed India Pvt.Ltd., Unit
Used to deliver supplemental oxgen or
29/Misc/03/2016- No.205,2nd floor, Southern Park,D-
16 Nasal Cannula increased airflow to a patient or person Not Regulated 2/14/2017
DC (351) 2,District Centre,Saket, New Delhi-
in need of respiratory help
110017
Used in cervical cancer screening by
M/s Khandelwal Laboratories Pvt.ltd.,
29/Misc/03/2016- TruScreen Ultra Cervical providing a direct means of tissue
17 78/87,Dattaram Lad Path,Mumbai- Not Regulated 2/14/2017
DC (196) Screening System differentiation as a primary screening
400033,Maharashtra,India
tool in the general population
29/Misc/03/2015- M/s Vygon India Pvt.Ltd., B-17,Infocity, Used a s connection tube between
18 Gravity Set Not Regulated 2/28/2017
DC (204) Section-34,Gurgraon-122001(Haryana) feeding tube and feeding bag
Spiegelberg probes viz.true
tunneling intraventricular
probe 7F & 9F, silverline
ventricular probe 8F,
M/s Inmito Meditech Pvt.ltd., 216-A, mointoring intracanial pressure
29/Misc/03/2016- Silverline Ventricular probe
19 Humyan Pur, Safdarjung Enclave, New measurement and drainage of Regulated 2/28/2017
DC (340) with cranial bolt 8F,
Delhi-110029 cerebrospinal fluids
Silverline Ventricular probe
10F, Probe 3N, Probe
3NXL, Probe 3DL and
Probe DLXL
Used as an adhesive to hold non -
Ten20 Conductive Paste disposable electoneurodiagnostic
M/s Morulaa Healthtech Pvt.ltd., Plot electrodes in place on intact skin sites
29/Misc/03/2017- No.38,1st Floor, Rajeshwari Street,
20 Not Notified 2/28/2017
DC (23) Santhosh Nagar,Khandanchavdi,Chennai-
96M/s Morulaa Healthtech Pvt.ltd., Plot
29/Misc/03/2017- No.38,1st Floor, Rajeshwari Street,
20 Not Notified 2/28/2017
DC (23) Santhosh Nagar,Khandanchavdi,Chennai- To reduce the impedance of the skin to
96 local potential differentials as
Nuprep Gel
measured by electroneurodiagnostic
and electrocardodiagnostic equipment
haemostatic dressing for use in surgical
surgeries when control of bleeding by
Velseal-TG
ligature, cautery or other conventional
methods are ineffective or impractical
M/s Datt Mediproducts Pvt.ltd.,
29/Misc/03/2017-
21 56,Community Centre, East of act as a space occupying dressing, Regulated 2/28/2017
DC (22)
Kailash,New Delhi-110065 preventing adhesion by separating the
ocmpromised muscosal surfaces and
Velnez
also,helping in healing and achieving
homeostasis in patients undergoing
nasal/sinus surgery
M/s Rithwik Pharma Pvt.ltd., Plot No.11-
13-1160/406,Ramprathap Niwas, Green
29/Misc/03/2017- CES UltraTM-Cranial treatment of insomnia, depression or
22 Hills Colony (Moyya Nagar), Near Not Regulated 3/15/2017
DC (19) Eectrotherapy Stimulator anxiety
Asthalaxmi Arch., L.B.Nagar,
Hyderabad,Telangana-500102
Use in the construction of most
M/s Innovee ,A-401, Selarka Sadan,
29/Misc/03/2017- common orthopedic casts, as well as
23 M.P.Vaidya Marg, Off.Tilak Road, Neal Cast Casting Type Regulated 3/15/2017
DC (24) specialized orthotics and prosthetics
Ghatkopar (East),Mumbai-400077
devices
temporary relied of minor muscle and
joint pain and stiffness: the remporary
M/s Morulaa Healthtech Pvt.ltd., Plot
relief of joint pain associated with
29/Misc/03/2016- No.38,1st Floor, Rajeshwari Street,
24 Avacen 100,A head therapy arthritis:muscle spasms, minor strains Not Notified 3/15/2017
DC (345) Santhosh Nagar,Khandanchavdi,Chennai-
and sprains, muscular relaxation and
96
the temporary increase of locak
circulation where applied
M/s HLL lifecare Limited, HLL Bhavan,
29/Misc/03/2016-
25 Poojappura,P.O.Thiruvananthpuram- Skin Stapler Nil Regulated 3/22/2017
DC (315)
695012M/s India Medtronic Pvt.Ltd., Used as a filter/purifier to remove
1241,Solitaire Corporate Park, Building toxins extracted from the body present
29/Misc/03/2017- Dialysate purification
26 No.12,4th floor, Andheri -Ghatkopar Link in the used dialysate and then balances Not Regulated 3/22/2017
DC (13) sorbent cartidge module
Road, Andheri (East),Mumbai- the ionic concentration of the purified
400093,India dialysate
M/s Vivyan Life Sciences Pvt.ltd.,
Used to get blood by perforating
29/Misc/03/2017- Corp.Off:-B-91,Flatted Factory complex,
27 Blood Lancet/Laser Lancet fingure tip skin of patient by using Not Regulated 3/22/2017
DC (36) Okhla Industrial area, phase-III,New Delhi-
single pulsed laser
110020
M/s Emergo India Consulting Used for endoscopic histological
Pvt.Ltd.,8/1,1st floor, Vasavi Colony, sampling of various tissue sites within
29/Misc/03/2017-
28 Kakguda, Near Pciket, Single use Biopsy Forceps the gastrointestinal and bronchial tracts Regulated 3/30/2017
DC (12)
Secunderabad,Hyderbad-Cir-2,Telangana- via the operationg channel of
500015 endoscopic instruments
M/s Truskin Gloves Pvt.ltd., Plot No.14-
29/Misc/03/2017-
29 C,Cochin SEZ, Kakkanad,Cochin- Sterile Surgical Gloves Nil Not Regulated 4/5/2017
DC (58)
682037,kerala,India
Rehabliliatation brace with Used in Joint disorders, pre-post-
M/s MTEX (I) Pvt.ltd.,A-26/4,Mohan Co- BOA Technology surgical treatment
29/Misc/03/2017-
30 Operative Industrial Estate,Mathura Road, Not Notified 4/5/2017
DC (50) used in the treatment of lower sirways
New Delhi-110044 Nebulizer
respiratory diseases like asthma
Dr.Rakesh Tulli, J C Bose National Fellow
and Sr Research Advisor, Univeristy
29/Misc/03/2016- Use in the orthodontic treatment for
31 Institute of Engineering and Technology, Dental Aligners Not Regulated 4/5/2017
DC (353) teeth alignment
Sector-25,Punjab University, Chandigarh-
160014
29/Misc/03/2017- M/s Fostril (I) Pvt.Ltd., G-36,outer Used to protect from dust and wood
32 Dust Filters Not Regulated 4/5/2017
DC (46) CIRCLE, CP,New Delhi-110001 splinters from entering the nose
Used to check an ongoing infusion
after desired volume of fluid has been
Infucheck
M/s Medprime Technologies Pvt.ltd., CM- infused and gives an audio alert for the
29/Misc/03/2017-
33 03,3rd floor, CSRE Bulding, IIT Bombay, same Not Regulated 4/5/2017
DC (37)
Powai, Mumbai-400076,maharashtra,India Used to help laboratory medicine
Cillika Microscope professional to make a diagnosis
through a portable digital platformGetting chemotherapy into cancer cells
using an electric pluse to send the
Electrochemptherapy
chemotherapy in to cancer cells-
M/s Brainrootz Labs Pvt.Ltd., 10-J, electroporation
29/Misc/03/2017-
34 Gopala tower, rajendra place,new delhi- Not Regulated 4/5/2017
DC (38) Combined Antineoplastic
10008 Treatment for the treatment of
Thermotherapy bladder
cancerous cells by using thermal
recirculation system
energy
(Combat BRS V4 System)
uSed in the anastomosis of veins and
M/s Myovatec Surgical System Pvt.Ltd., A-GEM Mircovascular
29/Misc/03/2016- asteries normally encountered in
35 12/42A,MIG DDA Flats, Kalkaji Anastomotic Coupler device Not Notified 4/5/2017
DC(262) microsurgical procedures only in the
Extension,New Delhi-110019 and system
peripheral vascular system
M/s General Medical Systems Pvt.Ltd.,
Used to get relief from swelling, pain
29/Misc/03/2017- Navdeep Industries Compound, Near Old
36 Piles GMS Relief Device and irritation in patients suffering from Not Notified 4/11/2017
DC (55) iNcome tax office, flood defence bandh,
piles
sirhind-140406,Punjab
Used as a topical agent in treatment of
M/s Synergy Pharma Formulations India
29/Misc/03/2017- esophageal and gastric lesions and to
37 Pvt.Ltd., 1003,Meadows, Sahar Plaza Esoxx Regulated 4/11/2017
DC (60) imporve symptoms of GERD or
Complex,J.B.Nagar,Andheri-400059
gastritis
Devitalized amniotic
membrane derived from Used to heal superficial ulcers
M/s Sri Research for Tissue Engineering
human placenta
29/Misc/03/2017- Pvt.Ltd., Sri Shankar Research Centre,
38 Sponge made with Regulated 4/18/2017
DC (21) Rangadore Memorial Hospital,1st Cross,
devitalized human amnitoic Used to heal drop ulcers in conjuction
Shankarpuram,Bangalore-560004,India
and chorion membrane and with negative wound pressure therapy
gelatin
Heckle HT3000,an infrared
Used for regernerative processess of
M/s Parazelus India whole-body hyperthermia
body,muscle relaxation
29/Misc/03/2017- Pvt.Ltd.,802,Thaneone,DIL Complex, device
39 Not Notified 4/24/2017
DC (73) Behind Cinewonder Mall,Majiwada, Hydrosun 750 or 575 an Used in treatment of degenerative
Thane West,Mumbai-400610,Maharashtra infrared heat treatment rhematic illness, chronic neuritis, spine
device disorders
M/s India Health Link Pvt.Ltd., Used to measure blood pressure, heart
29/Misc/03/2017-
40 SCO#394,New Grain Market, Health Kisok rate pulse, weight, body mass index, Not Regulated 4/24/2017
DC (79)
Karna,Haryana,India body mass composition ,ECGUsed to inflate the lungs of an
M/s Romsons Scientific & Surgical
29/Misc/03/2017- unconsious perosn is not breathing
41 Industries Pvt.Ltd., 63-64.Indutrial Estate, Resuscitator bag Not Notified 5/23/2017
DC (98) using positive pressure, in order to
Nunhai Agra-282006 (India)
keep them oxygenated and alive
M/s Accredited Consultants Pvt.Ltd., D- Circumferential excision of the
29/Misc/03/2017-
42 29,1st floo,r Acharya Niketan,Mayur Prepex foreskin or prepuce at or near the level Not Regulated 5/23/2017
DC (68)
Vihar-1,Delhi-110091 of coroary sulcus
To get relief from low back
29/Misc/03/2017- M/s Siddhi Vinayak Enterprises, New Wings Pain relief
43 pain,burises, sprains, stiff neck, joint Regulated 5/23/2017
DC (75) 11/343,Geeta Colony,Delhi-110031 patch
pain,muscle pain,frostbite
M/s Morulaa Healthtech Pvt.ltd., Plot
Used to be reduce night time snoring
29/Misc/03/2017- No.38,1st Floor, Rajeshwari Street,
44 MicrO2 and mild to moderate obstructive sleep Not Notified 5/23/2017
DC (99) Santhosh Nagar,Khandanchavdi,Chennai-
apnear (OSA) in adults
96
M/s IDS Denmed Pvt.Ltd., A-23/3,Ground
29/Misc/03/2017- Used for disinfection/dedorization and
45 floor, Mayapuri Industrial Area Phase- Clinical Disinfectants,Wipes Regulated 5/23/2017
DC (111) cleaning of Medical Device surface
1,New Delhi-110064,India
M/s Alaric Arooojis, Medical Director,
29/Misc/03/2017- CURE Clubfoot Maharashtra,B.J.Wadia Miracle Feet Foot Pilot study in the treatment of
46 Not Notified 23-05-2017
DC (49) Hospita, Acharya Donde Abduction Brace idiopathic Clubfoot
Marg,Parel,Mumbai-400012
M/s Innaumation Medical Devices, #1/1- Used as a mechnical speaking device,
Aum Voice Prosthesis
29/Misc/03/2017- 17,1st cross, KB Temple,6th Block, to help patients of throat cancer who
47 (Internal replacement Regulated 5/23/2017
DC (104) Rajajinagar, Banagalore- have lost their voice after surgical
prosthesis)
560010,Karnataka,India removal of voice box
To prevent or cure deep vein
Medical socks
thrombosis
to encourage blood circulation in the
Compression Socks limbs by applying pressure along the
muscles
P & A Law Offices, 1st floor, Dr.Gopal
29/Misc/03/2017-
48 Das Bhawan 28, Barahkhamba Road,New Deodrant Socks To reduce stiffness and odor of the feet Not Regulated 5/30/2017
DC (107)
Delhi-110001,India
Thermo Socks To keep soles, Legs and Feet warm
To reduce imflammation of the arch of
Socks with sole support
foot
To prevent falling and twisting of
Socks to prevent falling
anklesEndobronchial ultrasound endoscopes
for ultrasound guided fine needle
Quantacore HD
M/s Nano Therapeutics Pvt.Ltd., D- aspriration of the submucosal
29/Misc/03/2017- Endobronchial Ultrasound
49 54/2,Hojiwala Industrial Estate,Sachin masses,lymph nodes and Regulated 6/13/2017
DC (106) Transbronhial Aspiration
Surat,Gujarat-394230 intraperitoneal masses of the
Needle (EBUS-TBNA)
tracheobronchial tree and
gastrointestional tract
M/s KCI Medical India Pvt.Ltd.,
29/Misc/03/2017- No.1,Ramchandra Complex, 1st floor, 1st Adaptic Digit Non Adhering
50 a range of mild to severe digit injuries Regulated 6/13/2017
DC (120) cross, M.S.Nagar, Opp.Ayyapa Temple, Digit Dressing
Bangaluru-560038,Karnataka,Indi
Contactless Infrared To measure the temperature of various
Therometer surfaces, liquids and body
To make smooth breath and to
Piston Type Nebulizer trasnform liquid medicines into fines
M/s Sunheri Marketing Pvt.ltd., Shri Ram
easy to inhale for kids
29/Misc/03/2017- Marg,Huda Bypass,Sector-12,Opposite
51 Digital Blood Pressure To measure the blood pressure of Not Notified 7/11/2017
DC (121) Indo Spinning Mills,Panipat-
Machine human body
132103,Haryana,India
To smoothen the flow of mother milk
Electronic Breat Pump
from breast
Nasal Aspirator or Nose
To clean nose of infants
Cleaner
29/Misc/03/2017- M/s Medishare Ltd.,S-439,G.K.Part- To use as an adhesive to hold EEG
52 TEN 20,A conductive Gel Not Notified 7/11/2017
DC (132) 1,New Delhi-110048 Electrodes in place on intact sites
Disposable Hemoperfusion
M/s Delvin Surgicals Pvt.ltd., New Cartidges
29/Misc/03/2017-
53 No.25,12th Cross,Shastri (models:HA130,HA230,HA Treatement of specific intoxication Regulated 7/11/2017
DC (100)
Nagar,Adyar,Chennai-600020 280,HA330,HA330
II.BS330 & DNA230)
Topic and temporary treatment to not
infected skin lesions(eg.cuts, abrasions,
M/s Bryogen Pharmaceuticals Pvt.ltd., 8H Attracts
29/Misc/03/2017- wounds, minor llocalized burns,
54 Gopala, Tower, Rajendra Place, New Farmactive Silver Spray definition of 7/11/2017
DC (141) postoperative wounds, decubitus,
Delhi-110008 Drugs
ulcers, incontinence irritations or
diapers irritation)To transfer medication to the catheter
M/s Becton Dickinson India Pvt.ltd., Head
29/Misc/03/2017- Extension Tubing Assemble and provide multiple port sccess for
55 Office:-5th and 6th floor, Signature Tower Regulated 7/18/2017
DC (156) of the product Venflon 2.0 connectors with secondary flashback
B, South City 1,Gurgaon-122001,Haryana
by releasing the air only
To use for oral and enteral
administration of liquid
M/s Terumo India Pvt.ltd., 1601 &
29/Misc/03/2017- Terumo Oral and Eternal medication/nutrition and for flusing of
56 1602,Tower-B,16th floor, Unitect Cyber Not Notified 7/18/2017
DC (136) Syringes enteral feeding lines and aspiration of
Park,Sector-39,Gurgaon-122001,Haryana
stoamch fluid (during palcemnt of
enteral feeding system)
M/s Swastik Enterprises, 126-127,Hapa To inject a mircochip into an animal
29/Misc/03/2017- Brand Rfid Microchip
57 Indurtial Area, Jamnagar- for its identification and tracking Not Notified 7/25/2017
DC (160) Applicator
361120,Gujarat,India purpose
1.LiNA Port
2.LiNA FleXealTM 10
3.LiNA FleXealTM 5
1.LiNA Power blade
2.LiNA Lapscissors
3.LiNA Electrodes (blade
Sterile and single use devices used for
electrodes-coated,blade
M/s LiNA Medical India making the port entry in abdominal Regulated
29/Misc/03/2017- electrode coated and
58 Pvt.Ltd.,702,Madhuban Building, cavity 25-07-2017
DC (149) insulated, blade electrode)
55,Nehru Place,New Delhi-110019 Not regulated
4.LiNA Pencils (LiNA
Surgical equipments
Surgipen)
5.LiNA SeaStar TM and
LiNA Skin HookTM
6.LiNA EndoHookTM
7.LiNA AntiFod
SolutionTM (LiNA
elfred,LiNA Clear Sight and
M/s Teleflex Medical Pvt.Ltd., Old
Treatment of pneumothorax and
29/Misc/03/2017- No.10,No.19,1st floor and Ground floor,
59 Asherman Chest Seal preventing pneumothorax tension from Regulated 8/1/2017
DC (149) Harrington Road,Chetpet-
stab or gunshot wound
600031,Chennai,IndiaM/s Cipla Ltd., Regd Office Cipla House,
29/Misc/03/2017- Medication free dry powder To delivers the medication to the lungs
60 Peninsula Business Park,Ganapatro Not Notified 8/1/2017
DC (155) inhaler in the form of a dry powder
Kadam Marg, Lower Parel,Mumbai
M/s Sen Brothers Pvt.Ltd., TU Master Line F-Grip self
29/Misc/03/2017- Vaccination of Alvan. Bovine,
61 22,R.N.Mukherjee Road, 5th floor, filling dose reusable Not Notified 8/7/2017
DC (88) canine,feline
Kolkata-700001,India syringes
M/s Dialec Medical Services Pvt.Ltd.,Plot
29/Misc/03/2017- Prevent catheter related to bacteremia Regulated
62 No.311,Survey No.197, Block GA, 1st Citra-Lock solution 8/17/2017
DC (184) and clotting
floor,1st cross,karnataka-560038,
Dr.V.S.Venkatesan,Professor-Biomedical
In removal of urea, creatinine and other
29/Misc/03/2017- Engineering,TMA Pai Chair in Medical Artificial Kidney-Dialysis
63 unwanted material takes place across Not Regulated 8/17/2017
DC (140) Devices, Manipal Institute of Technology, Cartidge
the membrane from the blood
Manipal-576104,Karnataka,India
to be used as a smart phone based
Mobile ODT cervical imaging in cervical cancer
Dr.Shreemoyee De,International Oncology
29/Misc/03/2017- screening program
64 Services Pvt.Ltd., Fortis Hospital,Sector- Not Notified 8/17/2017
DC (164)
62,Noida Zilico (electrical impedence
Detecting cervical cancer
spectrograph devices)
M/s Oxycan Solutions Pvt.Ltd., 42 A/B, All natural and perfect alternative to
29/Misc/03/2017- 95% pure oxygen with and
65 Yogi Nagar Township, B/S Zenith Tins, the energy drinks, shots and Notified 8/29/2017
DC (103) without flavor
N.H.-8,Channai-391740,Vadodara supplements
M/s Koye Pharmaceuticals Pvt.ltd., Regd
Cleansing and debridement of wounds
29/Misc/03/2017- Office:-7,The Centrium,Phoenix Market
66 Jetx-ND/Jetforce and in treating diabetic ulcers,pressure Regulated 9/12/2017
DC (206) City, LBS Marg, Krla (West)-
ulcers,venous stasis ulcers and burns
400070,Mumbai-400070
Used for the flushing and cold storage
M/s Geneagles Global Health City,
of organs like heart, lung, kidneys,
#439,Cheran Nagar, Not
29/Misc/03/2017- TransMedics Organ Care liver and panceras at the time of
67 Sholinganallur,Medavakkam Road, Notified/Regulat 9/12/2017
DC (148) System removal from donor in preparation for
Perumbakkam,Chennai-600100,Tamil ed
storage,transportation and eventual
Nadu
transplantation in to recipientM/s Generix Life Sciences Pvt.Ltd., Unit Perinel U & Perinel Rehab,
29/Misc/03/2017- Treatment of stress incontinence, urge
68 No.4,5 & 6,207, 3rd floor, Shahpur Jat- a remote Controlled Not Notified 9/19/2017
DC (212) incontinence and mixed incontinence
110049,New Delhi incontinence stimulator
(Servator P,Servator C,
Servator B, Servator Used for theflushing, ex vivo cells,cold
B+,Histidine-Tryptophan- storage or organs like heart,lungs,
M/s Duraent Lifesciences LLP, 1-
29/Misc/03/2016- Ketogulterate kidneys, liver and pancreas at the time
69 98/9/12A,2nd floor, T & A Plaza, Jain Not Notified 9/26/2017
DC (131) (HTK),Eurocollins A+B, of removal from donor in preparation
Enclave, Hyderabad-500081
Belezer UW Cold storage for storage, transporattion and eventual
solution,penta starch transplantation in to recipient
solution
M/s Mavinbo Services, A/4, Anjali
29/Misc/03/2017- Histofreezer protable Cyyosurgical treatment for removal of
70 Society, M.Dmarg, Panchakhandi,Thane Regulated 9/26/2017
DC (158) cryosurgical system different types of warts and skin tages
(West),Mumbai-400602
Used for Flushing, perfusion,
Servator C, Servator B+, hypothermic preservation, component
Histidine-Tryptophan- in cryopreservation media for human
M/s Duraent Lifesciences LLP, 1- Ketogluterate ex vivo cells, cold storage of organs
29/Misc/03/2016-
71 98/9/12A,2nd floor, T & A Plaza, Jain (HTK),Eurocollins A+B, like heart, lung,kidneys, liver and Not Notified 9/26/2017
DC (131)
Enclave, Hyderabad-500081 Belezer UW Cold storage pancreas at the time of removal from
Solution, Penta Starch donor in prepartion for storage,
Solution transportation and eventual
transplantation in to receipient
M/s Emergo India Consulting
Pvt.Ltd.,8/1,1st floor, Vasavi Colony, Used in prevention and treatment of
29/Misc/03/2017-
72 Kakguda, Near Pciket, TransAeris System ventilator-induced diaphragm Not Notified 10/4/2017
DC (224)
Secunderabad,Hyderbad-Cir-2,Telangana- dysfunction (VIDD)
500015
M/s Myovatec Surgical System Pvt.Ltd., A-Conevita`s silicon
29/Misc/03/2017- Used to induce precocious satiety
73 12/42A,MIG DDA Flats, Kalkaji Intragastric ballon with Regulated 10/4/2017
DC (252) sensation in obese patients
Extension,New Delhi-110019 radio opaque catheter
M/s Laerdal Medical India Pvt.Ltd.,
Used to provide supplement of oxygen
29/Misc/03/2017- No.10,1st floor, 1st street,
74 Upright Oxygen Kit through the upright bag mask to the Not Notified 10/4/2017
DC (246) Dr.Subbararayan
baby
Nagar,Kodambakkam,Chennai-600024M/s Sibre Systems and Services Pvt.Ltd., SB Knife standard type, SB
29/Misc/03/2017- Used for Endoscopic sub mucosal
75 39,2nd Main Road, R.A.Puram,Chennai- Knife short type and SB Regulated 10/10/2017
DC (43) dissection
600028 Knife Jr.Type
M/s Goldwin Medicare Ltd.,
29/Msic/03/2016- 101/102,Vailankanni Towers, A Wing,
76 Srugical Dressings Regulated 10/16/2017
DC (304) Mari Nagar, Off.Senapati Bapat
Marg,Mahim (W),Mumbai-400016
Pain Relief and improvement of joint
Soy Phosphatidylcholine
M/s Troikaa Pharmaceuticals Ltd., Pots- function by lubricating damaged
29/Misc/03/2017- Gel
77 Thol, Tal-Kadi, Mehsana- cartilage not notified 10/16/2017
DC (265)
382728,Gujarat,India Polyacrylic Acid Vaginal Restoration of Vaginal Ph and
Gel maintenance of good vaginal health
Assisting users in achieving full
Does not fall
M/s Menz HEALTH International erection i.e. To create an erection in
29/Misc/03/2017- Boss-2000-2 Vaccum under the
78 Pvt.Ltd., 67/1,New Rihtak Road, Karol men with erectile dysfunction by 11/1/2017
DC (272) Erection Device notified
Bagh,new delhi-110005 means of an applied vaccum to the
categories
penis
Does not fall
M/s Borivli Rubber Works, A/3, Mangal
29/Misc/035/2017- Women during the menstruation time under the
79 Kunj, 1st Floor, S.V.Road, Borivli DEA Cup (Menstrual Cups) 11/1/2017
DC (268) for collecting the uterine lining fluid notified
(West),Mumbai-400092
categories
29/Misc/03/2017- M/s Tricell Bilogics, Plot No.4 &5, Separating a small volume of blood to
80 Tricell PRP Kit Not Notified 11/6/2017
DC (177) Dhanrajapuram, Kolathur,Chennai-600099 prepare Platelet/Cell concentrate
M/s Prime Medica Promotion Pvt.Ltd.,
29/Misc/03/2017- Splint made up of plaster of Temporary immoblization of fractures,
81 E/96, FIDC MANJUSAR,sSalvi Road, Regulated 11/6/2017
DC (273) paris sprains or strains in limbs
Vadodara-391775
M/s Robert Bosch Engineering and Capturing digital iamges and videos of Does not fall
Bosch Eye Cam (non-
29/Misc/03/2017- Business Solutions Pvt.Ltd., 123,Industrial the fundus/human eye, to be used as under the
82 Mydriatic fundus camera) 11/14/2017
DC (301) LAYOUT, Hosur Road, artifical intelligence for diabetic notified
and algorithm/software
Koramagala,Bangalore-560095 retinopathy screening categories
Disinfectant in hospitals,healthcare
Barbicide Concentrate Regulated
establishments
Disinfection, lubrication,
cleaning,cooling and as antirust by
Clippercide Spray Regulated
M/s Fashion Identity Pvt.Ltd., 13, Shreepal haridressers stylists, animal groomers
29/Misc/03/2017-
83 Complex, SUREN Road, Andheri and veterinarians 11/14/2017
DC (300)
East,Mumbai-400093M/s Fashion Identity Pvt.Ltd., 13, Shreepal
29/Misc/03/2017-
83 Complex, SUREN Road, Andheri 11/14/2017
DC (300)
East,Mumbai-400093 Cleaning brushes, combs, head,neck
Ship Shape Professional
and foot sinks, countertops, chairs, Not Regulated
CLEANER
caps and aprons
Ship Shape Powder Institutional dish machine detergents Not Regulated
M/s Woman`s Nature LLP, 95 &96, 1st It s a hand held electronic fertility
29/Misc/03/2017- Daysy,Pearly and Lady
84 floor, 21st Main Road, BSK,2nd indicators for pregency prevention and Not Notified 11/16/2017
DC (304) Comp/Lady Comp Basic
Stage,Bangalore-560070 family planning
Dr.Thacharodi`s
The licensing Authority, Govt of
Xenoderm,Dr.Thacharodi
29/Misc/03/2017- Puducherry,Dept of Drugs Control, Govt Not "New
85 Xzenostat,Dr.Thscharodi`s It is intended as skin/wound dressings 11/17/2017
DC (295) Hospital Building, 1st Floor, Drugs"
Collagen Dry Sheet,
Murungapakka, Kombakkam-605004
Dr.Thacharodi`s Xenoderm
M/s Daewoong Poharmceuticals Caretropin pen without Intended for injecting correct dose
29/Misc/03/2017-
86 (india)Pvt.Ltd., Plot No:-5A,APIIC, caretopin (somatropin) injection of somatropin from liquid Not Regulated 12/12/2017
DC (269)
I.E.Prashnath Nagar,Kukatpaaly,Balanagar liquid carthridge and cartridge by pressing injection button
The Under Secretary,DFQC Section,
29/Misc/03/2017- Orthopedic
87 Ministry of Heatlh and Family Welfare, Not Notified 12/18/2017
DC (306) Implants/equipments
Nirman Bhawan,New Delhi-110011
Shri R.Nihal Pedric, Deputy Director,
National Pharmaceutical Pricing
29/Misc/03/2017- Medical Devices,Catheters Notified and
88 Authority, Dept of Pharmaceuticals,3rs 12/18/2017
DC (228) and Stents Regulated
and 5th floor, YMCA Culture Centre
Building,No.1,Jai Singh Road, New Dlehi-
Disposable speculam Bio
M/s Ayurman Natural Fluff(arod shaped stem
29/Misc/03/2017- Intended for introduction of water and
89 Healthcare,1707,Sadashiv Peth, Near preassembled in ordcer to Regulated 12/19/2017
DC (270) the draining of excreted
Udyan Karyalaya,Pune-411030 facilitate the introduction
into the anus)
29/Misc/03/2017- M/s Dialec Medical Services Pvt.Ltd.,Plot Citra Lock solution is Intended to prevent catheter related
90 Regulated 12/19/2017
DC (184) No.311,Survey No.197, Block GA, 1st claimed to be having anti bacteremia and clotting
Electro Inpedence
Intended for imaging and diagnostics
29/Misc/03/2017- M/s InkosbioPharma, R-775,2nd Floor, Mammograph under the
91 of pathological changes of the breast Not Notified 12/19/2017
DC (314) New Rajendra Nagar, New Delhi-110060 models MEM 20-11 &
tissues
MEM 20-08
M/s Luvia Trading Pvt.Ltd.,#947,JMD O-Lens unde rthe models
29/Misc/03/2017-
92 Megapolis,Sector-48,Sohanan JENITH3,Russian to used as contact lens Not Notified 12/26/2017
DC (326)
Road,Gurgaon-122018,Haryana Velvet,Secriss3M/s Delta Biosciences Pvt.Ltd.,#1,Saini
29/Msic/03/2017- Dental Implants instruments
93 Complex, Dadu Majra, Chandigarh- Used in dental surgery Not Regulated 12/26/2017
DC (325) ,drills and surgical kits
1600142018 Database
Regulatory
S. NO. File . No. Name of the Company and Address Product Name Intended Use Date of Issue
Status
For self curing glass inomer based radiopaque filling
1 29/Misc/03/2017-DC (338) M/s Oralla Dental Private Limited GIC Inomer Cements Not Regulated 1/1/2018
cement
For purposes of performing root canals and related
Dental Root Canal
2 29/Misc/03/2017-DC (340) M/s Delta Biosciences Pvt.Ltd. dental procedures,by a trained professional in general Not Regulated 1/1/2018
Disinfection Kit
dentistry
3 29/Misc/03/2017-DC (328) M/s Meril Endo Surgery Pvt.Ltd. Sterile Surgical Sutures Nil Regulated 1/8/2018
For matching tube or syringe to control the flow rate that
4 29/Misc/03/2017-DC (341) M/s CliniExperts Services (P) Ltd Infusion Pump Regulated 1/8/2018
is infused into patients
Fro apex localization and working length determination
5 29/Misc/03/2018-DC (08) M/s Orbit Life Sciences Pvt.Ltd. NovApex N31 Apex Locator Not Notified 1/8/2018
during root canal treatment by dentist
1.Pall Ultipor 100 Braething
system Filter
6 29/Misc/03/2018-DC (21) M/s Pall India Pvt.Ltd. 2.Pall breathing system filter For eliminating filters or breathing filters Not Notified 1/12/2018
3.Pall Pharm Assure 25mm
hydrophobic vent filter
For treating patients with symptomatic heart failurte due
Optimizer Smart-A cardiac
to left ventricular dysfunction by delivering non
7 29/Misc/03/2018-DC (04) M/s Impluse Dynamics (USA) Inc. contractility modulation Not Regulated 1/12/2018
excitatory cardiac contractility modulation (CCM)
system
electricial signals to right ventricle8 29/Misc/03/2018-DC (17) M/s Halyard Helath India Pvt.Ltd. Sterile Drapes Nil Regulated 1/12/2018
Topical Skin Adhesive and
9 29/Misc/03/2017-DC (329) M/s Meril Endo Surgery Pvt.Ltd. Nil Nil 1/12/2018
Surgical Adhesive
Eustachian Tube Balloon
10 29/Misc/03/2017-DC (344) M/s Meril Life Sciences Pvt.Ltd. Nil Nil 1/12/2018
Dilation System
For in all sorts of medical facilities, which need to treat
surgical closure, wound trauma, skin
M/s Ingress India Healthcare
11 29/Misc/03/2017-DC (346) Woudn Care dressing Spray inflammation,suppurative skin infection and providing Regulated 1/15/2018
Consultants
first sid treatment of all sorts of wound happended in
field operations, sports, military training and outdoor
For easy insertion of catheters, scoops, rectal
12 29/Misc/03/2018-DC (10) M/s Reckitt Benckiser India Pvt.Ltd. K-Y tm Lubricating jelly Not Notified 1/15/2018
thermometers,enemas,docuhes
Used by officer workers,atheletes, pregnant and
Air Breath, canned breathing
13 29/Misc/03/2018-DC (53) M/s Air-O -Pure breastfeeding women,children,persons having asthma Not Notified 2/15/2018
air
and chronic illness citizens
1.KIWI Omnicup 9VAC
Used for foetal vaccum delivery assistance in conditions
6000M
of 1) Dystoica 2) uterine inertia 3) maternal exhaustion
14 29/Misc/03/2018-DC (02) M/s Bion Atrium Medical Care Pvt.Ltd. 2.KIWI Omnicup with Not Regulated 2/15/2018
(ineffective voluntary effort) or 4) maternal or foetal
traction Force Indicator
distress
(VAC 6000MT
M/s Philips India Limited, Plot No.B-
79,MIDC, Phase-II,Chakan Interventional and diganostic
15 29/Misc/03/2018-DC (56) Nil Not Notified 2/15/2018
Taluka,Khad, Village-Savardari,Pune- X Ray equipment
410601,Maharashtra,India
M/s Contect Critical Solution Pvt.Ltd.,
A 403-404,Sector-47,Sohna Use for sporocidal solution for cleaning/disinfecting
16 29/Misc/03/2017-DC (294) Conetct Sterile Hydrop[ure Regulated 2/23/2018
Expressway,Gurgaon- hard surfaces coming in contact with the product
122002,Haryana,IndiaM/s Mylan Pharmaceuticals Pvt.Ltd., Definition of
Plot No.1-A/2,MIDC, Industrial End Warts Pen and End Drugs Under
17 29/Misc/03/2018-DC (13) Used for removal of warts on hands, arms and feet 2/23/2018
Area,Taloja, Panvel Raigad (Dost.)- Warts Bottle as per Section
410208,Maharshtra,India 3(b)(i)
M/s Magal Health Care Pvt.Ltd.,
Rythmic evolution infusion
No.34,2nd Floor, 60 Ft.Road, NGEF Used for administration of prescribed liquid medication
18 29/Misc/03/2018-DC (03) pump without intravenous Not Notified 2/23/2018
Layout,.RMV Iind Stage,Sanjaynagar- and solutions to the body
set/catheter/spike set
560094,Bangalore
M/s Dialec Medical Services Pvt.Ltd.,
Citra-Lock solution is
Plot No.311,Survey No:-197,Block GA,
claimed to be having anti Used for prevention catheter related bacteremia and
19 29/Misc/03/2017-DC (184) 1st Floor, 1st cross, M.S.Nagar, Opp Regulated 2/26/2018
microbial,anti coagulant and clotting
Ayyapa temple, bengaluru-
anti bio film properties
560038,Karnataka
M/s NA Life Science, No.19,5th street,
Used for fever management,temporary relief oh
20 29/Misc/03/2018-DC (68) Banker`s Colony, Kumaran Nagar, Fever Cooling Patch Not Notified 2/27/2018
headache,toothache and muscle pain
Vayalur Road,,Trichy-620017
Electro mechanical equipmet
M/s CURA Healthcare Pvt.Ltd., No.A- (Accupush)
Not Regulated
32,Phase-1,MEPZ SEZ, Tambaram
21 29/Misc/03/2018-DC (78) Nil 3/13/2018
Kadapperi,chennai-600045,Tami Hypodermic
Regulated
Nadu,India syringes,hypodermic needles
and catheter(extension tube)
M/s Freyr Software Services Pvt.Ltd.,
Level 4,H-08 Building,SEZ Location- Polisorb Devioce (Mineral used for the treatment of diarrhea,nuasea,
22 29/Misc/03/2018-DC (80) Phoenix Infocity Pvt.Ltd., Advance based gastrointestinal vomiting,flatus, bellyache,food borne and drug allergic Regulated 3/13/2018
Business Hub, Gachibowli,Telanagan- detoxifier) reactions in adults and children
5600081
The Deputy Drugs Controller (I),4th
Used as an antimicrobial (effectice against viruses,
Floor,Zonal FDA Bhawan,GMSD
23 29/Misc/03/2018-DC (54) Vaprox HC Sterilant bacteria, yeasts and bacterial sporeS) when used in V Regulated 3/16/2018
Compund, Bellasis Rd., Mumbai
PRO low temperature sterilization system
Central,Mumbai-400008
M/s Uber Diagnostics pvt.Ltd.,
Cardiotrack device (12
24 29/Misc/03/2018-DC (101) No.1670,1st Floor, 18th cross, MC To conduct Clinical trials /validations Not Notified 3/15/2018
Chennel ECG Device)
Layout,Vijayangar,Bangalore-560040
Intended to provide relief from vomiting, nausea,
Motion Sickness Patch anorexia and other symptoms resulted from sickness of 3/19/2018
cars, ships, airplanes and other means of transport
M/s Samson Laboratories Pvt.Ltd., SCO
25 29/Misc/03/2018-DC (25) 40,Swastik Vihar, MDC, Sector- Regulated
Warmer pad/Menstrual Intended for temporary relief of minor menstrual cramp
5,Panchkula-134109 3/19/2018
Cramp relief patch pain and assocaited back aches by way of heat therapyM/s Samson Laboratories Pvt.Ltd., SCO
25 29/Misc/03/2018-DC (25) 40,Swastik Vihar, MDC, Sector- Regulated
5,Panchkula-134109
Intended for reducing temperature in fever, relief in
Cooling Gel Patch 3/19/2018
tiredness ,sleep ,daze,toothache,headache etc.
M/s GlaxoSmithKline Consumer
Pvt.Ltd., 24-25 Floor, One Horizon
26 29/Misc/03/2018-DC (90) Nasal Congestion Device Used for reliving nasal congestion in infants Not Notified 3/23/2018
Center, Sector-43,dlf Phase -5,Golf
Course Road, Gurgaon-122001,Haryana
M/s Quantleap Consulting,107,primrose, Diastolic and systolic leg Used externally on intact skin (thigh and calf) to
27 29/Misc/03/2018-DC (110) Serene country,telecom nagar, compression device, a non - enchance blood flow towards proximal parts of the body Not Notified 3/23/2018
hyderabad-500032 invasive compression device by increasing tissue pressure in thigh and leg
M/s Immito Meditech Pvt.Ltd., 216A,
Implantable neurostimulator Used to reduce the sysptoms associated with parkinson`s
28 29/Misc/03/2018-DC (93) Humayunpur, Safdarjung Enclave, New Not Notified 3/23/2018
DBS System disease
Delhi-110029
eXeM Foam Kit containinga
M/s DSS Imagtech Pvt.Ltd., A-5,Mohan
syringe witH ExEm Gel, A Intended for recongition of tubal aptency during the
29 29/Misc/03/2017-DC (332) Industrial Estate, Mathura Road, Delhi- Regulated 3/27/2018
syringe with ExEm water and ultrasound procedure
110002
a coupling device
M/s RPK Pharma Pvt.Ltd., Plot No.IV, Used to get relief from swelling, pain and irrritation in
Not Notified
APHB Colony, patients suffering from haemorrhoids
30 29/Misc/03/2017-DC (330) Memthol Barrier Spray 4/3/2018
Pedagantyada,Vishakhapatnam, Andhra As per the therapeutic claim, the product attracts the
Regulated
Pradesh-530044 definition of the Drug
m/S Datt Mediproducts Pvt.Ltd.,
31 29/Misc/03/2018-DC (107) 56,Community Centre, East of Velnext foam Dressing Kit Nil Regulated 4/3/2018
Kailash,New Delhi-110065
M/s BSN Medical Pvt.Ltd., B-10,Lotus
Leukomed IV/IV
Park,Jay Coach Junction, Opp.Raheja Intended for holding or fixation of surgical dressings, IV
32 29/Misc/03/2018-DC (65) Film,Fixomull Stretch Not Notified 4/6/2018
Ridgewood, Jogeshwari-400063, Tubes, catheters etc
/Transparent and Leuopor
Maharashtra
Monarch Enterprises,6-6-
35/2,Kavadiguda, Eurofix, Eurotrasp and Intended for fixation of dressings, bandagaes, tubes,
33 29/Misc/03/2018-DC (89) Not Regulated 4/9/2018
Secudnerabad,Telanagan- Eurosilk venous catheters and medical probes etc.
500080,Hyderabad
M/s AQS Biocair Pvt.Ltd., Rishi Homes,
Disinfectant solution witha
Flat S1,B-Block, No.191,Samyapuram Itended to disinfect the home, office, healthcare,
34 29/Misc/03/2018-DC (119) ctive ingredient hypocholirte Regulated 4/9/2018
nagar, 6th Street,Vanagaram,Chennai- ambulances,manfuatcuring unit etc.
ions
600095,Tamil Nadu
M/s Peroba Ventures Pvt.Ltd.,
Sonata Sonograpghy Guided Intended for providing radiofrequency ablation of Regulated as
308,Brigade Gateway Apartements,
35 29/Misc/03/2018-DC (302) Transcervical Fibroid uterine fibroids using a transcervical approach without ÄBLATION 4/9/2018
Dr.Rajkumar Road,
Ablation system incisions or material uterine distension DEVICE
Malleswaram,Bengaluru-560055M/s Predible Health Pvt.Ltd.,
BN189,Bapuji Intended for 3D Visualization,segmentation and
36 29/Misc/03/2018-DC (145) Predible Liver Software Tool Not Notified 4/10/2018
Nmagar,Pongumoodu,Trivandrum- quantative analysis of liver anatomy
695011,Kerala
M/s CURA Healthcare Pvt.Ltd., No.A- SinoPower -S, SinoPower-D Used to inject conrtast medium for CT and DSA
Not Regulated
32,Phase-1,MEPZ SEZ, Tambaram and SinoAngio 1200 respectively
37 29/Misc/03/2018-DC (77) 4/12/2018
Kadapperi,chennai-600045,Tami Syringe, connecting tube and Used to inject contrast medium for CT and DSA
Regulated
Nadu,India fill tube respectively
Intended to be used for non invasive full asssessment of
M/s Medicom International Eyetetch
teh ocular surface trhough a combination of tests for dry
38 29/Misc/03/2018-DC (154) Pvt.Ltd., 305-C, Iris Tech Park, Sohna ICP Ocular Surface Analyzer Not Notified 4/18/2018
eye diagnosis, from tear break up time to teh tear volume
Road, Sector-48,Gurgaon-122018,India
production test
Intende for effective removal of warts from hands, arms
Regulated as
and feet by freezing the wart at temperature of -80
M/s Mylan Laboratories Limited, Plot EndWartz Freeze ÄBLATION
degree celcius achieved by pressure mechanism of
39 29/Misc/03/2018-DC (137) No.564/A/22,Road No.92,Jubilee DEVICE 4/19/2018
nitrious oxide (cold gas)
Hills,Hyderabad-500034
Naloc Pro, an effective Intended for prevention and treatment of nail fungal Regulated as
solution injection i.e.onychomycosis "Drugs"
M/s Intutive Surgical India Pvt.Ltd., C/o Instrument Arm Intended to maintains terility of the sterile field when
Regus Suburb Centres Pvt.Limited, Drape,Camera Arm and Head non sterile protions of the da vinci Xi System (IS4000
40 29/Misc/03/2018-DC (164) Not Regulated 4/23/2018
Level 4, Dynasty, A Wing, Andheri- Drape,Column Drape and Surgical System) enter the sterile field by covering the
Kurla Road,Mumbai Arm 4 ExtensioN Drape parts of instuments
M/s HP India Sales Pvt.Ltd., Building
HP Healthcare Edition
No.2,DLF Cyber Greens, DLF Cyber Intended to view medical images for image capture
41 29/Misc/03/2018-DC (155) HC270cr Clinical review Not Notified 4/23/2018
City,1-4 Floor,Tower D & E,Phase- vertification
Monitor
III,Gurgaon,Haryana
M/s ConvaTech India vt.Ltd.,SY
No.217,Next Logistics Dock -4, Soukya SurePress High Compression
42 29/Misc/03/2018-DC (153) Intended for use over a primary wound dressing Not Regulated 4/23/2018
Road, Next to Police Station,Korallur Bandage
Village, Banaglore-560067
M/s Divya Baby and Mother care (P)
Divtya Double electric breast Intended to be used to smoothen the flow of milk from
43 29/Misc/03/2018-DC (172) Ltd., 135 F, 2nd Floor, Pocket-IV, Not Notified 4/24/2018
pump breast
Mayure Vihar,Phase-1,Delhi-110091
M/s Alcon Laboratories (India) Pvt.Ltd.,
3rd Floor, Crescent-4, Prestige Intended to be used in conjugation with cataract surgery
44 29/Misc/03/2018-DC (64) CyPass Ultra System Regulated 4/26/2018
shantiniketan,Whitefield,Bangalore- for reduction of intraocular pressure
560048M/s Transpact Enterprises Pvt.Ltd.,
204,Timmy Arcade, Makwana Road, Intended for vestibular, neuro developmental and
45 29/Misc/03/2017-DC (296) Vestibulator Not Notified 5/1/2018
MarolA,nheri East,Mumbai- sensory integration therapy
400059,Maharashtra,India
M/s Dorthom Medi Dents Pvt.Ltd., Used in dental periodontal,oral and maxillofacial
UNRA 25A, NCC Road, surgical procedures to encahnce the bone regenration in
46 29/Misc/03/2018-DC (111) GRABIO GLASCERA Regulated 5/9/2018
Ambalamukku,Peookada,Thiruvanantha lost or fractured bone areas, procedures to enchance the
puram-695005 bone regenration in lost or fractured bone areas
It is used to retrieve shape foreign objects from GI tract
through the scope. It is fixed on the tip of endoscope to
Foreign Body Retrieval Hood
protect mucosal tear and to prevent esophagus tare while
removing sharp foreign bodies.
Balloon Inflation Device To Inflate Balloon
For the help of balloon examination of structures within
EUS Balloon
or adjacent to the intestinal wall over the EUS scope
Used for endoscopic ligation of esophageal varices at or
Multi Band Ligator
above gastro esophageal junction
Used for endoscopic retrieval of foreign bodies from GI
Loop Basket
tract and to retrieve polyp through colonoscope
Used for endoscopic excision of polyps using single
Polypectomy Snare mono polar electrosurgical unit and retrieval of foreign
bodies from GI tract
Spring Tip Steel Guide Wire Used to guide esophageal dilators for dilatation
Used to gain access through difficult biliary and
pancreatic strictures. To facilitate exchange of
Neg Guide Wire
compatible wire guided accessories to the desired biliary
or pancreatic ducts.
Used to gain access through difficult biliary and
pancreatic strictures. To facilitate exchange of
Hydra Neg Guide Wire
compatible wire guided accessories to the desired biliary
or pancreatic ducts.
To gain access through difficult biliary and pancreatic
strictures. To facilitate exchange of compatible wire
Nitinol Black Wire
guided accessories to the desired biliary or pancreatic
ducts.
Hydra neg combo guide wire with tip at both end used to
Hydra Neg Combo Guide
gain access endoscopically through the difficult
Wire
strictures.
M/s Shaili Endoscopy ,Plot No.210
47 29/Misc/03/2018-DC (126) &213, Padara Jambusar Road, Dabhasa, Regulated 5/9/2018
Padra,Vadodara-391440,GujaratUsed to gain access endoscopically through difficult
Stiff Guide Wire
strictures
Used to gain access through difficult biliary and
Super Stiff Hydra Neg Guide pancreatic structures and to facilitate exchange of
Wire compatible wire guided accessories to the desired biliary
or pancreatic ducts
Wire Guided Stone
Used for endoscopic extraction of biliary stones
Extraction Balloon
Single Action Stent Used for easier stent placement and endoscopic biliary
Introducer System stent placement to reduce time
Stent Pusher For endoscopically biliary stent placement
Used to dilate papilla or biliary strictures through the
Biliary Dilator
scope.
Used endoscopically to opacify the biliary duct with
ERCP Cannula
radio opaque contrast material for fluoroscopic view
M/s Shaili Endoscopy ,Plot No.210
47 29/Misc/03/2018-DC (126) &213, Padara Jambusar Road, Dabhasa, Used for suction and coagulation during endoscopic Regulated 5/9/2018
Padra,Vadodara-391440,Gujarat Suction Coagulation Probe mucosal resection
Esophageal Dilator Used to dilate esophageal strictures over previously
placed wire guided
Used to collect cells from upper and lower
Cytology Brush
gastrointestinal tract
Eso Gastric Balloon
To deflate previously placed ESO gastric balloon
Deflation Device
Used to facilitate manipulation/ removal of stones can
Stone Grasper
also be used for removing stents from urinary tract
Eso Gastric Balloon Retrieval
For retrieval of ESO gastric balloon
Device
Indicated for the manipulation and removal/retrieval of
Stone Basket
stones from urinary tract
Indicated for the manipulation and removal/retrieval
Nephrostomy Basket
from urinary tract
Probe For Nephrostomy
To apply lithotripsy to break stone from urinary tract
Basket
Used to gain access endoscopically urology through the
Neg Guide Wire
difficult strictures in urinary tract
Used to access urologytract for access and exchange of
Hydra Neg Guide Wire
accessories in urinary tract
To gain access through difficult urological strictures. To
Nitinol Black Wire facilitate exchange of compatible wire guided
aceessoriesM/s Shaili Endoscopy ,Plot No.210
47 29/Misc/03/2018-DC (126) &213, Padara Jambusar Road, Dabhasa, Regulated 5/9/2018
Padra,Vadodara-391440,Gujarat
Used to gain access endoscopically through the difficult
Hyneg Combo Guide Wire
strictures.
Used to gain access endoscopically through the difficult
Stiff Guide Wire
strictures
Spray Probe Used to spray dyeing
Cournual Cannulation Set Used for ovarian cannulation
Clips For Endoclip Used to mechanically bind blood vessels
It is a delivery system used to deliver clips for achieving
Endoclip Applicator emostatis for:mucosal/submucosal defeats, bleeding
ulcers/arteries, surgery sites
It is used to close two mucosal surfaces without the need
Clipping Device for surgery or suturing or used to mechanically bind
blood vessels (the device holds the clips)
It is used for endoscopic cannulation of bilary ductal
Sphincterotome system. It is a triple lumen catheter accommodating a
guidewire, cutting wire, contrast medical channel
It is used for precut paillotomy.It has triple lumen design
facilitating for cannulation after incision of the pailla
Needle Knife without requiring that the catheter be exchanged. Triple
lumen accomodates a guidewire, cutting wire and
conrast medical injection channel.
Itneded for ENT Surgery usingquantam molecular
Double Pin Bipolar electrode
resonance generator
Designed to cute,dissect,manipultae and /or cauterize
Laparoscopic Scissors various tissues during endoscopic/laproscopic surgical
procedures
Not Regulated
Used to intoroduce fluids into body cavities other than
Single use Bladder Evacuator blood vaessels,drain fluids from body caivities or
avaluate certain physiologic conditions
Dsiposable lap electrode L Used in Laproscopic surgery for cauterizing and
Hook and Spatula manipulation of tissues and veseels
Used to grasp tissue, retrieve foreign bodies, and remove
Laparoscopic Graspers
tissues from within the gastrointestinal tract
Laparoscopic Irrigation Used to introduce fluids into body cavities other than
M/s Glowtronics Pvt.Ltd., 1D, Suction Set (LISS Assembly blood vessels, drain fluids from body cavities, or
48 29/Misc/03/2017-DC (334) Hootagalli Industrial Area,Mysore- and body probe) evaluate certain physiologic conditions. 5/9/2018
570018,India
Used to collect tissue, or foreign body retrieval, from
Single use Biopsy Forceps
Gastrointestinal tract using an endoscope
Used for endoscopic ligation of oesophageal varices and
Multiple Band Ligator
anorectal haemorrhoids RegulatedM/s Glowtronics Pvt.Ltd., 1D,
48 29/Misc/03/2017-DC (334) Hootagalli Industrial Area,Mysore- 5/9/2018
570018,India
Regulated
Used for diagnostic evaluation of bile ducts during
laproscopic cholecystectomy. They are designed to grasp
Cholangiography Clamp and introduce contrast medium into gallbladder for
evaluation of stones, blockage and or other
abnormalities
Used to sample targeted submucosal gastrointestinal
Endoscopic Ultrasound
lesions through the accessory channel of an ultrasound
(EUS) Needle
endoscope
Pleural drain Used to drain fluids from the chest cavity
Intended use direct filling restorations using light curing
composite or compomer, cavity sealing as pretreatment
for indirect restorations, treatment for hypersensitive
and/or exposed root surfaces, intraoral repair of
fractured facing crowns made of porcelain,hybrid
Clearfill SE Bond
cermics or composite resin, surface treatment of
prosthetic appliances made of pprcelain,hybrid cermics
or composite resin, surface treatment of prosthetic
appliances made of porcelain, hybrid ceramics and cured
composite resin
Intended use cementation of metal crowns and bridges,
inlays and onlays, porcelain crowns, veneers,resin
Panavia F2.0
crowns, adhesion bridges, endodontic cores and
prefabricated post bonding
Intended use direct restorations for anterior and posterior
Clearfill AP-X teeth Class III,IV,V restorations of anterior teeth,cervical
cavitites of root surfaces defects
Intended use direct restorations for anterior and posterior
teeth (Class I-V Cavities),Direct veneers,coorection of
Clearfill AP-X Esthetics tooth position and tooth posititon and tooth shape
(diastemna closure, dwarfed tooth), Intraoral repairs of
M/s Confident Sales India Pvt.Ltd.,
fractured crowns/bridges
No.47,2nd floor, Pete Channappa
49 29/Misc/03/2018-DC (87) Not Regulated 5/11/2018
Industrial Estate,Magadi Main Road,
Intended use -Direct restorations for anterior and
Kamakshipalya,Bangalore-560079
posterior teeth (Class I-III Caivities, cervical caries,root
Clearfill AP-X Flow
erosion), cavity base/liner, intraoral repairs of fractured
crowns/bridges/composite resinM/s Confident Sales India Pvt.Ltd.,
No.47,2nd floor, Pete Channappa
49 29/Misc/03/2018-DC (87) Not Regulated 5/11/2018
Industrial Estate,Magadi Main Road,
Kamakshipalya,Bangalore-560079
Intended Use adhesion of metal inlays, onlays, crowns
,bridges and metal posts, repair of fractured resin based
Alloy Primer facing crowns and porcelain fused mtal crowns and
bridges, fabrication of removable dentures with metal
base clasp or attachment,repair of denture
Intended use detects carious dentine for cavity
Caries Detector
preparation
Intended use surface treatment of porcelain,cermics,
hybrid ceramics or composite resin, intra-oral repairs of
Ceramic Primer
fractured crowns/bridges made of porcelain, ceramics,
hybrid ceramics, hybrid ceramics or composite resin
Intended Use Cementation of crowns, bridges, inlays
and onlays, made of ceramic (such as zirconia and
Clearfill SA Luting
alumina) ,composite resin on mtela, cementation of
metal cores,resin cores, metal posts or glass fiber posts
Intended Use-Enamel and dentin bonding agent for
Clearfill Photo Bond
direct composite restorations
Intended for surgical closure as Class B device under the
Surgical Incision Closure
privision of D& C Act and MD Rules 2017
M/s A V Medical Systems, 18,1st Floor,
50 29/Misc/03/2018-DC (176) B1/16,New Kondli, Mayur Vihar, Phase- Intended to fix Drainage catheters and ventilation mask Not Notified 5/11/2018
III,Delhi-110096 used during endoscopy allowing intraprocedural
Drainage Tube Fixing
treatment of respiratory complications without
interrupting the procedure
M/s Cook India Medical Devices
Tissue grafts, staple line
Pvt.Ltd., 4/249-A,Rasim Enclave,
reinforcement and dural Intended to reinforce soft tissue and as a substitute for
52 29/Misc/03/2018-DC (192) Poonamallee High Road,Goparasanallur, Regulated 5/11/2018
grafts derived from animal repariing dura matter
KattuPakkam,Chennai-600056,Tamil
origin
Nadu
Intended to be used to quickly and completely solidify
DeRoyal Solidifier
M/s Premier Enterprises, No.39/2,South blood and body fluids for disposal
53 29/Misc/03/2018-DC (128) Street, Chatrapatti-626102,Via Intended to be used to aid in the management and Not Notified 5/15/2018
Safeliner semi-rigid liner
Rajapalayam,Tamil Nadu disposal of waste fluid during variety of medical
system
procedures
M/s Nobel Biocare, UnitNo.702,7th
AdvanSync 2 (Orthodontic Intended to be used during orthodontic treatment to
54 29/Misc/03/2018-DC (159) floor,A Wing, Supreme Business Park, Not Notified 5/15/2018
Dental Bracket) move the teeth
Supreme City,Powai,Mumbai-400076M/s Nobel Biocare, UnitNo.702,7th
55 29/Misc/03/2018-DC (158) floor,A Wing, Supreme Business Park, Orthodontic Dental Bracket Intended use during orthodontic treatment to moveteeth Not Notified 5/15/2018
Supreme City,Powai,Mumbai-400076
M/s Medicom International Eyetetch Intended for soothing relief for tired and sore eyes and
Evolve Eye Mask (Reusable
56 29/Misc/03/2018-DC (205) Pvt.Ltd., 305-C, Iris Tech Park, Sohna soothing relief for gritty sensation or irritation on the Not Notified 5/15/2018
moist heat mask)
Road, Sector-48,Gurgaon-122018,India external closed eye surface
M/s ConvaTech India vt.Ltd.,SY
Unometer Safeti Plus
No.217,Next Logistics Dock -4, Soukya Intended for collection and measuring the urine voume
57 29/Misc/03/2018-DC (204) containing tubing and urinary Not Regulated 5/15/2018
Road, Next to Police Station,Korallur output in critically ill patients
drainage bag without catheter
Village, Banaglore-560067
M/s Digital e-Life Pvt.Ltd., Kamalini Hydropumps, Vibe Rings,
58 29/Misc/03/2018-DC (22) Building,Top Floor, Central Avenue Power Rings and related Intended for non medical use Not Regulated 5/15/2018
Road,Chembur (E),mumbai-400071 accessories
M/s BSN Medical Pvt.Ltd., B-10,Lotus
Park,Jay Coach Junction, Opp.Raheja LeukoFix and Fixomull Inetnded for holding or fixation of dressings,catheters
59 29/Misc/03/2018-DC (210) Not Regulated 5/22/2018
Ridgewood, Jogeshwari-400063, Gentle Touch dressing ,IV Tubes,cannulae,etc.
Maharashtra
M/s Riddhi Associates, B-276,Okhla Intended to be used in gastric bypass and sleeve
60 29/Misc/03/2018-DC (217) Industrial Area,Phase-1,New Delhi- MiniMizer Gastric Ring gastrectomy operations, for sustained and effective Not Notified 5/22/2018
110020 weight loss in bariatic surgery
M/s Intuitive Surgical India Pvt.Ltd.,C/o Instrument Arm Intended to maintains terility of the sterile field when
Regus Suburb Centres Pvt.Ltd., Level- Drape,Camera Arm and Head non sterile protions of the da vinci Xi System (IS4000
61 29/Misc/03/2018-DC (164) Not Regulated 5/24/2018
4,Dynasty, A-Wing, Andheri-Kurla Drape,Column Drape and Surgical System) enter the sterile field by covering the
Road, Mumbai Arm 4 ExtensioN Drape parts of instuments
Mucus extractor,Double J
Stent,Abdominal Drain Kit
having drainage catheter and
The Drugs Controller, Govt of
collection bag, Polypropylene
Rajshthan,Drug Control Organtization,
62 29/Misc/03/2018-DC (230) Non Absorbable synthetic Nil Regulated 5/24/2018
Swasthya Bhawan,Tilak Marg, Room
surgical mesh,Bone
No.308,3rd Floor, Jaipur,Rajasthan
Wax,Pressure Monitoring
Line/High Pressure
Extension Line
Intended to grasp tissue, retrieve foreign bodies and
Laproscopic Grasper
remove tissues from within the gastrointestinal tract
M/s Glowtronics Pvt.Ltd., 1D,
63 29/Misc/03/2017-DC (334) Hootagalli Industrial Area,Mysore- Intended to collect tissue or foreign body retrieval, from Regulated 5/28/2018
Single use Biopsy Forceps
570018,India Gastrointestinal tract using an endoscopyM/s Glowtronics Pvt.Ltd., 1D,
63 29/Misc/03/2017-DC (334) Hootagalli Industrial Area,Mysore- Regulated 5/28/2018
570018,India
Intended for endoscopic ligation of oesophageal varices
Multiple Band Ligator
and anorectal haemorrhoids
M/s BSN Medical Pvt.Ltd., B-10,Lotus
Intended to be used for the protection of skin
Park,Jay Coach Junction, Opp.Raheja Delta Dry Stockinetter
64 29/Misc/03/2018-DC (206) udnercasting materials Not Regulated 5/30/2018
Ridgewood, Jogeshwari-400063,
Delta Dry Reyonsa Intended to be used to keep the skin dry
Maharashtra
M/s Medicom International Eyetetch
65 29/Misc/03/2018-DC (181) Pvt.Ltd., 305-C, Iris Tech Park, Sohna E>Eye Medical Equipment Intended to treat dry eye syndrome Not Notified 6/6/2018
Road, Sector-48,Gurgaon-122018,India
It is used for direct administration of oxygen through the
Oxygen Catheter
naso pharynx.
It is used for short term post-operative drainage of
Kehr’s T Tube
common bile duct.
It is used for short term bladder catherterisation through
Female Catheter
urethra in females.
Chest/Thoracic Drainage It is used for post operative drainage after cardio
Catheter thoracic surgery.
It is used for rapid non operational pleural and chest
Thoracic Trocar Catheter
M/s GPC Medical Ltd., M Block, DDA, drainage.
66 29/Misc/03/2018-DC (246) Regulated 6/13/2018
LSC, Vikas Puri, New Dlehi-110018 It is used for aspiration of secretion from oropharynx in
Mucus Extractor
newly born babies.
It is an effective device for close wound drainage under
Redon Drainage Catheter negative pressure with the option to use one catheter or
two catheter simultaneously.
It is used for removal of secretion and blood pass during
Yankaur Suction set
surgical procedure
It is used for high pressure monitoring and connection
Pressure monitoring line
between syringe and infusion pump.
Male external catheter It is used for urine incontinence in male patient
M/s Bio India Interventional
Technolgooies Pvt.Ltd., Plot No.14,Unit Inetnded for mild to severe unicompartmental knee
67 29/Misc/03/2018-DC (252) Oactive Knee Brace Not Regulated 6/13/2018
A-2,Near Charak Pharma,Umbergam, osteoarthritis
Dist.Valsad, Gujarat-396171
Smarport Disposable Intended to be used for creating a path of entry trhough
M/s Tripod Healthcare Pvt.Ltd.,3, Circus Paproscopic Access System tissue planes and or potential spaces and maintain a
68 29/Misc/03/2018-DC (182) Range, Kolkata-700019,West is a sterile device containing working channel for the passagage of Regulated 6/13/2018
Bengal,India a path of entry cannula (with laparoscope/endoscope/instrument/device for
a one way stop cock ) performing minimal access surgeryEDTA Cream used to clean root canal of pulp, blood
vessels, nerve net using a roatry root canal isntrument by
MD-Chel Cream removing inorganic sustance by chelation action.nly
used for cleaning purposes, will not remain in the root
canal.
Used to cleanse the root canal, is in liquid form and
removves the inorganic substance from the root
MD-Cleanser
canal.Only used for cleaning purposes, will remain in the
root canal
Adseal Resin based root Resin based root canal cemen.Allows creation of
canal sealer hermetic seal of root canal/
Used to fill the root canal after cleaning and shaping the
Gutta Percha Points
root canal
Absorbent Paper Points Used to dry the root canal
Metapex Calcium Hydroxide Premixed paste, radio-opaque, provided in Syringe for
with Iodoform easy delivery of the paste to the Canal
Glass Fiber Post, light translucency for efficient light
NexPost Fiber Post cure deep into the root canal & optimal Flexural
Strength (close to dentin)
M/s Confident Sales India pVt.Ltd.,
No.47,2nd floor, Pete Channappa NexCore Dual Cured core To restore lost tooth structure, strong cement helps build
70 29/Misc/03/2018-DC (55) Industrial Estate, magadi Main Road, build Up material it Not Regulated 6/14/2018
Kamakshipalya, Bangalore-560079 MD-Temp Plus Hydraulic Temporary filling material used to close the caivty after
Temporary Restorative tooth cutting
Contains Zinc Oxide, Spontaenous setting.Material use
NETC Non-Eugenol
to make a temporay crown until permanent crown can be
Temporary Cement
prepared
Use for conditionsing of dentin surface so that later teh
Meta Etchant filling will adhere to the tooth.Also for conditioning
Enamel to fix Inlay/Onlay on the tooth
Bonding for porcelin, direct composite, metal Repair, set
Meta P & Bond
amalgam and post
Used as a cavity liner before making permanent.Filling
Biner LC this has better thermal conductivity. It also stimulate
formation of secondary dentin.
Used for composite & porcelain repairs, allows optimum
Nexcomp handling, excellent sculptability for restoring natural
shape & function
Low viscosity, light-cured, radio-opaque flow able
Nexcomp Flow composite resin for minimally invasive cavity
preparation.
Intended to Reduce the Size of prostate gland entering
Turp (Transurethral
through urinary tube of male patients by removing
Resection of Prsotate ) Loops
abnormal tissues (Class C)
M/s Mysore Wilfiltronics Pvt.Ltd., A-
71 29/Misc/03/2017-DC (331) 4A,Hootagalli Industrial Area, Mysore- Regulated 6/14/2018
570018,Karnataka,IndiaIntended for excision, conagulation or electro-conization
of abnromal tissue, growth or lesions in teh cervix called
Diathermy Loops cervical intraepithelial neoplasia (CIN) and HPV related
condylomata acuminate,in combination with ane
lectrosurgical generator (Class C)
Intended for surgery in conjunction with surgical
septoplasty under anesthesia using endoscopy and
Tubr-bi-probe
incision in lining tissue around tubinate by cauterizing
with radio frequency or elctrical current (Class C)
M/s Mysore Wilfiltronics Pvt.Ltd., A-
Intended for prcedure to dissolve scar tssue around
71 29/Misc/03/2017-DC (331) 4A,Hootagalli Industrial Area, Mysore- Regulated 6/14/2018
entrapped nerves in the Epidural Space of spine to
570018,Karnataka,India
enable reach of cortisone into affected areas.The
Resaflex Probe
procedure involves inserting the function part of the
probe into skin and deeper tissues to dissolve the scar
tissue using resonance (Class C)
Intended for procedure to dissolve scare tissue around
entrapped nerves in the Epidural space of spine to enable
reach to cortisone into affected areas. The procedure
Resadisc Probe
involves inserting the function part of the probe into skin
and deeper tissues to dissoolve the scar tissue using
resonance (Class C)
Intended for Amputates the uterine orpus from the cervix
Lap Loop
during laproscopicsupracervical hysterctomy (Class c)
M/s Septondent Healtchare India septo etch, secure Bond
72 29/Misc/03/2018-DC (268) pvt.Ltd., C-1/2,MODC, Taloja, Panvel, ,Endure Nano and Endure Used for restoration of tooth Not Regulated 6/19/2018
Dist.Raigad-410208 Flow
M/s Koye Pharmaceuticals Pvt.ltd., A-
Intended for open airway and immoblization of the
10,Art Guild House,Phoenix Market
73 29/Misc/03/2018-DC (269) Lubo Airway Collar cervical spine in traumatic patients on emergency Not Regulated 6/19/2018
City Annexe, LBS Marg,
situations
Kamani,Kurla,Mumbai-400070
Shri Saurin Gandhi, 7/159,Jain Paradise, Oximeter, Nebulizer, Bed
74 29/Misc/03/2018-DC (277) Jain Society, Sion (Wets),Mumbai- Wetting alaram and Air Nil Not Regulated 6/22/2018
400022 Pollution
m/S Datt Mediproducts Pvt.Ltd., Bovine Thrombin Powder Does not have
Intended for topical dressing for emergency use in case
75 29/Misc/03/2018-DC (186) 56,Community Centre, East of used for manufacturing predicate 6/27/2018
of sevreely bleeding wounds
Kailash,New Delhi-110065 haemostatic patch deviceM/s TS Comprozone Pvt.Ltd., Office
No.1,Swaralata Apt., Off Gokhal;e Endovenous laser therapy of
76 29/Misc/03/2018-DC (227) Used for laser pulse Regulated 6/28/2018
Road, Naupada,thane- Varicose Veins
400602,Maharashtra
M/s Agastsa Software Pvt.Ltd., Office
Pcket ECG Device -Sanker
77 29/Misc/03/2018-DC (294) NO.121,Corethum ,Plot NO.A-41,Sector- Itneded to Monitor ECG Not Regulated 6/28/2018
Life
62,Noida-201301
Intended for lagophthalmos for temporary facial
External Eyelid weight
paralysis or bell`s palsy
Designed for the gravity-assisted treatment of the
functional defects of lagophthalmos resulting from facial
paralysis. The implantation of a weight implant allows a
Eyelid weight implants passive reanimation of the eyelid to correct functional
defects such as ocular irritation, Conjunctival
dessication, Conjunctivis, Keratitis, Corneal ulceration,
Epiphora and Pain and discomfort.
Surgical treatment of ptosis requiring brow suspension,
Ptose- up where levator palpebrae are unusable. The band is placed
between the tarsal plate and occipitofrontalis muscle.
M/s Carl Zeiss India (Bnagalore)
Pvt.Ltd., Plot NO.3, Block 2,Vision
78 29/Misc/03/2018-DC (255) Surgical treatment of ptosis requiring brow suspension Regulated 7/3/2018
Jigani Link Road, Bommasandra
and Ptosis probe is autogenous or homologous materials
Industrial Area,banaglore-560099
offer the following advantages such as reduced operating
Ptosis Probe
and hospitalization time as well as a single operative
site. Elimination of the inherent morbidity linked to
harvesting autogenous material.
Implantable device as circular band used to prevent the
eyelid from adhering to the eyeball and occasionally for
Symblepharon Ring glaucomaPrevent the retraction of the conjunctival culs-
de-sacs.The Wide central hole avoids corneal contact
while preserving the cornea
It is used for lacorhinostomy derivation between the
Metaireau Tubes internal canthus and the nasal fossa
Dacryocystorhinostomy (conventional or laser).
M/s Geetha Manunath,PhD, Co foudner
CEO,Niramal Health Analytix Pvt.Ltd., Thermalytix,a non -invasive
79 29/Misc/03/2018-DC (281) Intended to be used for Diagnostics of breast cancer Not Notified 7/5/2018
A7-506,Elita Promenade, J P Nagar, 7th device
Phase,Banagalore-78M/s. Regency Lifesciences India Pvt.
Ltd., 8, 4th A Cross, 5th Main, HRBR Duragraft Vascular Conduit
80 29/Misc/03/2018-DC (297) Nil Nil 7/5/2018
2nd Block, Kalyanagar, Bangalore- Storage
560043
Under the
M/s Reckitt Benckiser (India)pvt.ltd.,
Intended to ease vaginal dryness and intimate discomfort definiton of
81 29/Misc/03/2018-DC (12) Plot No.48,Sector-32,Institutional area, Durex Play Lubricant 7/5/2018
and applied to imtimate areas prior to sexual intercoruse Drug/New
gurgaon-122001
Drug
M/s. Cloudncare E-Health Pvt.Ltd., A-
Virtual Reality anatomy 3D Intended for medical imaging, digital learning,
82 29/Misc/03/2018-DC (241) 402 Ridgeview, IFS Society, Sector Not Notified 7/18/2018
Visualization table peropoerative image analysis and simulation
54,Gurgoan-122011, Haryana
M/s CliniExperts Sservices Pvt.Ltd.,
Unit No.325,City Centre mall, Plot Negative pressure wound Used to enhance and promote wound healing in acute,
83 29/Misc/03/2018-DC (347) Regulated 7/20/2018
No.5,Sector-12,Dwarka,New Delhi- therapy device chronic and burn wounds
110075
Used for exploring the lacrimal canal (the lacrimal duct)
Lacrimal Dialator and probes
duriing an ophhalmic procedure
Punctum Dilator and Plug Facilities the insert plug portion of all monocanalicular
Inserter intubation systems into punctum
M/s Carl Zeiss India (Bnagalore)
Used for the temporary mechanical dilatation of the
Pvt.Ltd., Plot NO.3, Block 2,Vision Disposable Iris Retractor
84 29/Misc/03/2018-DC (225) margins of the iris during ophthalmic surgery Not Regulated 7/23/2018
Jigani Link Road, Bommasandra
Industrial Area,banaglore-560099 Sizer for autostbale Enables to choose the appropriate length of masterka or
intubation set II autostable bicanaliculus intubation set II
Determine the proper orbital implant diameter for
Sizers Set
enucleation or evisceration
M/s NovoMed Incorporation Pvt.Ltd.,
Shop No.103,the Summit Business
NATROX Oxygen wound
85 29/Misc/03/2018-DC (170) BayPrakashwadi,Near Cinemax Cinema, Intended for wound hearing Regulated 7/23/2018
therapy system
Village Gundavalli,Andhri-Kurla Road,
Mumbai-400093
M/s Leixir Resources Pvt.Ltd.,
Artifical Teeth (HS Code
101,Vatika Business Park,Tower-2,
86 29/Misc/03/2018-DC (326) 90212100) (Customized Nil Not Notified 7/23/2018
Sohna Road,Sector-49,Gurgaon-
dental crowns and bridges)
122018,Haryana
M/s Convatec India Pvt.Ltd., SY
No.217,Next Logsitics Dock -4,Soukya Sensi Care Sting Free Intended to be used for atraumatic removal of medical
87 29/Misc/03/2018-DC (329) Not Notified 7/23/2018
Road, Next to police station,korallur Adhesive Releaser Spray adhesivces,wound dressings and appliances
village, banaglore-560067
Intended to be used for inflating the balloon or stent
M/s Skylabz, Plot No.3/156/4D,SKS
Inflation device during angioplasty by creating positive pressure Regulated
Nagar, Ayya Ramasubbu
88 29/Misc/03/2018-DC (316) connected to stent delivery catheter 7/23/2018
Lane,Pandikovli ring road, madurai-
625020,TNM/s Skylabz, Plot No.3/156/4D,SKS
Nagar, Ayya Ramasubbu
88 29/Misc/03/2018-DC (316) 7/23/2018
Lane,Pandikovli ring road, madurai-
Intended for holding and twisting guidewire during
625020,TN Torque Device Not Notified
interventional procedures
M/s Haitech Medical Solutions Pvt.Ltd., Intended for root canal grafting for repair of root
Orthomta
510,Bhaveshwar Arcade, Annex Area, perforations, internal resportion and apexification
89 29/Misc/03/2018-DC (325) Not Regulated 7/24/2018
Opp Shreyas Cinema, Behind Sarawat Intended for vital pulp therapy for deciduous and young
RetroMTA
Copoerative bank,lbs road, Mumbai teeth and repair material for permanent teeth
M/s Convatec India Pvt.Ltd., SY
Intended for the protection of damaged at risk and peri
No.217,Next Logsitics Dock -4,Soukya Sensi Care Sting Free Skun
90 29/Misc/03/2018-DC (333) wound skin from the detrimental effects of body waste, Not Notified 7/24/2018
Road, Next to police station,korallur barrier Spray
enzymes and adhesives
village, banaglore-560067
M/s FCL Vision (OPC) Pvt.Ltd., D3- Color Perfection (Theatrical
Intended to enchance or alter the apparent colour of the
91 29/Misc/03/2018-DC (343) Block ,B-1,KH No.69,1st floor, Mahavir eye accessories) reusable Not Notified 7/24/2018
eye
Enclave, New Delhi-110045 conatct
M/s BEMPU Helath Pvt.Ltd.,#32, Alsa
Intended to be used to detect and correct apnea for pre
92 29/Misc/03/2018-DC (357) Glenridge Apartment 3C, 3rd floor, BEMPU Apne Boot Not Notified 7/24/2018
maturity
Langford Road, Bangalore-560027
M/s CliniExperts Sservices Pvt.Ltd.,
Unit No.325,City Centre mall, Plot Under
93 29/Misc/03/2018-DC (274) Import Organ Care system Nil 7/25/2018
No.5,Sector-12,Dwarka,New Delhi- Regulation
110075
M/s Hollister Medical India Pvt.Ltd.,
Plot No.27,Sector-5,Phase-II, HSIIDC, Stoma Cone Irrigation Intended to be used for routine irrigation to regulate
94 29/Misc/03/2018-DC (355) Regulated 7/25/2018
Growth Center, Bwai- System emptying of the bowel
123501,Haryana,India
M/s Browndove Healtchare Pvt.Ltd., Dialyzer with Blood tubing
Intended for filtering the blood
Plot No.318/A, Harohalli ,2nd pahse, set
95 29/Misc/03/2018-DC (218) Regulated 7/26/2018
Industrial area, kanakapura Taluq., Intended for suctioning of secretions, blood and debris
Yankauer suction Set
Kamanagar-562112 peri-operatively
M/s Monitra Healthcare Pvt.Ltd., 202, ECG Monitor (upBeat),a non
Intended to be used for detection of heart rhythm
96 29/Misc/03/2018-DC (359) Mani Niketan, Plot No.496, Defence -invasive adhesive sensor Not Notified 7/27/2018
disorders
Colony, Sainikpuri, Hyderabad-500094 patch
M/s Orbit Lifesciences ,Mehtra Mahal,
Intended to be used to cut and drill the teeth for
97 29/Misc/03/2018-DC (358) 7th floor, 15,mathew road, opera house, NeoDiamond Burs Not Notified 7/27/2018
rootcanal treatment
mumbai-400004
High Concerntration Oxygen
M/s Romsons Medicons ,E-20,Foundary Intended for delivering oxygen and medication to treat
98 29/Misc/03/2018-DC (342) Mask,Oxygen Mas and Not Regulated 7/31/2018
Nagar,Agra-282006 respiratory disorders
Nebulizer
Intended for delivering oxygen for inhaling small
Nasal Oxygen
amount of supplement
M/s Romsons Medicons ,E-20,Foundary
99 29/Misc/03/2018-DC (328) Regulated 7/31/2018
Nagar,Agra-282006M/s Romsons Medicons ,E-20,Foundary
99 29/Misc/03/2018-DC (328) Regulated 7/31/2018
Nagar,Agra-282006 Intended to clamp over the newborn infants umbilical
Umbilical cord clamp
cord after delivery and prevent the blood loss
M/s Evelabs Technologies Pvt.Ltd.,V V Intended to be used as supplementary ekectroonic drip
Dripo Smart Infusion
100 29/Misc/03/2018-DC (352) Nivas, Archal Nediyara ,P.O.,Anchal monitor in standard gravity infusion and set gravity Regulated 7/31/2018
Monitor
Kollam,Kerala-691306 infusion rates (Flor Regulation )
            

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