Data / Medical devices / China / Suzhou Sunmed Co., Ltd

Suzhou Sunmed Co., Ltd: FDA-registered device maker in SUZHOU CITY Jiangsu, China, 1 510(k) clearance

Name: Suzhou Sunmed Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Suzhou Sunmed Co., Ltd is registered with the FDA (registration 3005533873) in SUZHOU CITY Jiangsu, China. It lists 28 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 13, 2007. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3005533873
Address: No.88 Shishan Road, SUZHOU CITY Jiangsu, China, 215011
Owner or operator: SUZHOU SUNMED CO., LTD (10046764)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: May 8, 2014
Registered through: 2027
Brand names listed: Absorbent gauze products, Alcohol Pad, Ankle Support, Arthritis gloves; Compress gloves, Cold And Hot Therapy Pack, Heat Pack, Compression Night Garment, Compression Day Garment, Compression Garment Socking, CuraBlue Silver Foam, Dressing Kit and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Manufacturer	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Manufacturer	accessdata.fda.gov
Bag, Ice	KYR	1	Manufacturer	accessdata.fda.gov
Band Or Belt, Pelvic Support	ISR	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Manufacturer	accessdata.fda.gov
Dispenser, Solid Medication	NXB	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Manufacturer	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Exporter to the US, Manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Manufacturer	accessdata.fda.gov
Finger Cot	LZB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
First Aid Kit Without Drug	OHO	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Insoles, Medical	KYS	1	Manufacturer	accessdata.fda.gov
Joint, Ankle, External Brace	ITW	1	Manufacturer	accessdata.fda.gov
Joint, Knee, External Brace	ITQ	1	Manufacturer	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Manufacturer	accessdata.fda.gov
Shoe, Cast	IPG	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-Sterile	NOC	1	Manufacturer	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)	FQL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Suit, Surgical	FXO	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 13, 2007	K060832	RETRO-TECH DRESSING	FRO	Substantially Equivalent	Retro-Tech, LLC	accessdata.fda.gov

Compare with other makers

Updated March 13, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.