Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030088999

FEI Number

3030088999

Entity Name

GRI ALLESET INDIA PVT. LTD.

City/State/Country

Umbergaon Gujarat, IN

Establishment Address

Plot no. 241/1 +2, GIDC Road, Umbergaon, Tal: Umbergaon, Dist: Valsad, Umbergaon Gujarat 396171, IN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GRI Alleset India Pvt. Ltd. (Owner Number: 10078215)

Owner / Operator Contact Address

Plot no. 241/1 +2, GIDC Road, Umbergaon, Tal: Umbergaon, Dist: Valsad, Umbergaon, IN-GJ 396171, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PrepSleeve Occlusive wound dressing GRI Alleset

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2023-04-09
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-10-14

Official Correspondent

No official correspondent registered.

US Agent Details

Martin Paugh Email: mpaugh@gri-china.com Phone: (678) 5238977

Related Public Records

Same Entity

GRI Alleset India Pvt. Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030088999. Last updated year: 2026. Please use registration number 3030088999 when referencing this establishment in official correspondence.