Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010807315

FEI Number

3010807315

Entity Name

GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.

City/State/Country

Wuhu Anhui, CN

Establishment Address

Industrial Zone, Yijiang Town,, Nanling, Wuhu Anhui 241311, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. (Owner Number: 9068839)

Owner / Operator Contact Address

1805 HONGGAO ROAD, Xiuzhou Industry Zone, JIAXING, CN-ZJ 314031, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ComfortGuard Surgical Gown, i600, Film Reinforced Halyard GRI-Alleset CleanOp Disposable Bedding ECOLAB Kimberly-clark HALYARD BASICS SURGICAL GOWN RoyalGuard Surgical Gown, I600, Breathable Alleset Invenio Value Select Surgical Gown Alleset

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-07
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-03-27
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2005-07-18
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2010-10-25
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-01-08
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2010-07-19
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2025-04-16
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2011-02-10

Official Correspondent

No official correspondent registered.

US Agent Details

MARTIN D PAUGH Email: mpaugh@gri-usa.com Phone: (678) 5238977

Related Public Records

Same Entity

GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., 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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10

Similar Registrations

Registration Number	Establishment Name	Location
3043535425	K-ONE MEDITECH SDN. BHD.	Sekinchan Selangor, MY
3012508471	P3 MEDICAL LTD	Bristol Bristol, City of, GB
3004133257	AMMAR APPAREL II S. DE R.L DE C.V.	CALKINI Campeche, MX
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
3019798849	EXCELLENT MEDICAL TECHNOLOGY (THAILAND) CO., LTD.	U-Thai District Phra Nakhon Si Ayutthaya, TH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010807315. Last updated year: 2026. Please use registration number 3010807315 when referencing this establishment in official correspondence.