What does Jiangsu Guangda Medical Material Group Co., Ltd. manufacture?

Registered with the FDA for 32 device types.

Is Jiangsu Guangda Medical Material Group Co., Ltd. still registered with the FDA?

Yes. The registration is current and expires 2026.

Jiangsu Guangda Medical Material Group Co., Ltd. → Supplier → Allomedo

Jiangsu Guangda Medical Material Group Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Bag, Ice, Pad, Eye and 30 other device types. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2007.

32device types registered with the FDA

5products catalogued under its own name

2510(k) clearances

Registration

FDA registration record for Jiangsu Guangda Medical Material Group Co., Ltd.
Status	Registered
Registration expires	2026
Registration number	3006847952
FEI number	3006847952
DUNS	421295761
Establishment type	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer

Chinese Registration

Chinese company register details for Jiangsu Guangda Medical Material Group Co., Ltd.
Chinese legal name	江苏广达医材集团有限公司
Source	Qichacha company register

Location

Address of Jiangsu Guangda Medical Material Group Co., Ltd.
City	Haian
Province	Jiangsu
Address	18 Baochang Road North
Postal code	226631
Country	China

What It Makes

Device types Jiangsu Guangda Medical Material Group Co., Ltd. is registered to make
Device type	Class	Listed under the names	Listed since	Chinese makers
Accessory, Surgical Apparel	Class 1	Face mask, Coverall	2008	439
Applicator, Absorbent Tipped, Sterile	Class 1	Cotton Tipped Applicators, Sterile	2013	100
Applicator, Ent	Class 1	Wood Applicator	2013	25
Bag, Ice	Class 1	Ice Bag	2013	86
Bandage, Elastic	Class 1	Bandage, Elastic	2007	280
Bedding, Disposable, Medical	Class 1	baby blanket; stretcher sheets	2008	308
Camera, Surgical And Accessories	Class 1	Cover	2017	22
Cap, Surgical	Class 1		2008	178
Cotton, Roll	Class 1	Cotton Ball; Cotton Roll	2008	107
Counter, Sponge, Surgical	Class 1		2007	17
Cover, Shoe, Operating-Room	Class 1		2007	176
Depressor, Tongue, Non-Surgical	Class 1	Tongue Depressors	2013	100
Device, Occlusion, Umbilical	Class 1	Device, Occlusion, Umbilical	2019	18
Dissector, Surgical, General & Plastic Surgery	Class 1		2008	14
Dissector, Tonsil	Class 1		2008	4
Drape, Surgical, Antimicrobial	Class 2	Drape, Surgical	2008	39
Drape, Surgical, Exempt	Class 2	Drape, Surgical, Exempt	2017	107
Dress, Surgical	Class 1	Medical Disposal Protective Clothing	2022	71
Dressing, Wound, Hydrophilic	Class 1		2008	195
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Class N	Face Mask	2020	182
Fiber, Medical, Absorbent	Class 1	Towel	2008	172
Gauze / Sponge,Nonresorbable For External Use	Class 1		2007	266
Gauze/Sponge, Internal, X-Ray Detectable	Class 1	Gauze/Sponge, Internal, X-RAY Detectable	2007	67
Gown, Examination	Class 1		2007	109
Gown, Surgical	Class 2	Gown, Surgical	2020	68
Mask, Surgical	Class 2	Mask, Surgical	2021	125
Non-Surgical Gown	Class 1		2007	318
Pad, Eye	Class 1		2008	100
Parenteral Administration Kit	Class 2	Insulin Injection Kit	2025	5
Sheet, Burn	Class 1		2008	20
Stabilizer, Heart	Class 1	Stabilizer, Heart	2015	9
Tape And Bandage, Adhesive	Class 1		2007	353

Own-Brand Listings

Devices catalogued by Jiangsu Guangda Medical Material Group Co., Ltd.
Product	Code	Catalogue numbers
GD	PUI	12
GD	GDY	8
GD	NAB	7
GD	KME	2
GD	FYF	1

Clearances

2 clearances name Jiangsu Guangda Medical Material Group Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Jiangsu Guangda Medical Material Group Co., Ltd. or its listings
Clearance	Decision date	Product code	Route	Held by
K201718	2021-04-15	FXX	Traditional	This company
K121152	2012-12-12	FYA	Abbreviated	This company
K001858	2000-08-17	KKX	Traditional	China Nantong Guangda Textile Co., Ltd.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Jiangsu Guangda Medical Material Group Co., Ltd.
Founded	2005
Employees	700
Main products	gauze sponges, lap sponges, surgical towels, medical face masks
Certifications	ISO 13485, EN ISO 11135:2014, FDA

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Jiangsu Guangda Medical Material Group Co., Ltd.