Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006847952

FEI Number

3006847952

Entity Name

Jiangsu Guangda Medical Material Group Co., Ltd.

City/State/Country

Haian Jiangsu, CN

Establishment Address

18 Baochang Road North, Haian Jiangsu 226631, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Guangda Medical Material Group Co., Ltd. (Owner Number: 10023676)

Owner / Operator Contact Address

18 Baochang Road North, Haian, CN-JS 226631, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MASK, SURGICAL Drape, Surgical, Exempt GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE Tongue Depressors Towel Medical Disposal Protective Clothing DRAPE, SURGICAL Ice Bag BANDAGE, ELASTIC Cotton Ball; Cotton Roll Wood Applicator Stabilizer, Heart Cover Face mask Coverall

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-04-17
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-03
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2007-12-07
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2013-03-19
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2008-11-24
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2022-10-14
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2008-11-25
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-11-24
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2013-12-30
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2008-11-24
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2007-12-07
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2007-12-07
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2007-12-07
EFN	Cotton, Roll	Dental	Class 1	872.6050	2008-11-24
FME	Gown, Examination	General Hospital	Class 1	880.6265	2007-12-07
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2013-03-19
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2008-11-24
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2008-11-24
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2015-04-10
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2017-05-19
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2007-12-07
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2007-12-07
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2008-11-24

Official Correspondent

Guo Rong

US Agent Details

Guo Rong Email: operations@gdmed.com Phone: (858) 8691098

Related Public Records

Same Entity

Jiangsu Guangda Medical Material Group 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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006847952. Last updated year: 2026. Please use registration number 3006847952 when referencing this establishment in official correspondence.