Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030956456

FEI Number

3030956456

Entity Name

GARWARE HEALTHCARE INDIA PVT LTD

City/State/Country

Satara Maharashtra, IN

Establishment Address

PLOT No. B-137, Opp Garware Technical Fibres Ltd, WAI MIDC, Satara Maharashtra 412803, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Garware Fulflex India Private Ltd (Formerly Garware Bestretc (Owner Number: 9069342)

Owner / Operator Contact Address

Supreme Headquarters 9TH FLOOR Survey#36, Baner, Pune Bangalore Highway, Pune, IN-MH 412 803, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MS17301 Tourniquet 1inx18in Latex Free Blue Tape and bandage, adhesive Pack, hot or cold, reusable BAG, ICE X-TEN) ESMARK MULTIPLE (COMPRESSION PEDIATRIC Elastic Bandage Splint, extremity, non-inflatable, external, non-sterile FIBER, MEDICAL, ABSORBENT Dressing, compression

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2005-11-07
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-04-05
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-12-15
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2024-12-15
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2005-01-04
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2024-04-05
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2024-12-15
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2024-12-15

Official Correspondent

No official correspondent registered.

US Agent Details

Elisa Maldonado-Holmertz Business: Obelix Consulting Email: elisamh@obelixconsult.com Phone: (512) 4316069

Related Public Records

Same Entity

Garware Fulflex India Private Ltd (Formerly Garware Bestretc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004956798	Garware Fulflex India Private Ltd (Formerly Garware Bestretch Ltd)	SATARA Maharashtra, IN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Similar Registrations

Registration Number	Establishment Name	Location
3027555965	INNOVATE MEDICAL MALAYSIA, SDN. BHD.	Shah Alam Selangor, MY
3008973900	SAFECARE MEDICAL PRODUCTS CO., LTD. (HEFEI)	HEFEI Anhui, CN
3030461038	PLASTICOSCRT, S.A. DE C.V.	Santa Catarina Nuevo Leon, MX
3014146184	WHEELSTONE ENTERPRISE CO., LTD.	Taichung City, TW
3030191206	XMETIX LTD	Nazareth Northern, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030956456. Last updated year: 2026. Please use registration number 3030956456 when referencing this establishment in official correspondence.