Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005533873

FEI Number

3005533873

Entity Name

SUZHOU SUNMED CO., LTD

City/State/Country

SUZHOU CITY Jiangsu, CN

Establishment Address

NO.88 SHISHAN ROAD,, SUZHOU CITY Jiangsu 215011, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SUZHOU SUNMED CO., LTD (Owner Number: 10046764)

Owner / Operator Contact Address

NO.88 SHISHAN ROAD,, SUZHOU CITY, CN-JS 215011, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Emergency blanket; Fire blanket adjustable orthopedic knee braces post op shoe, heel wedge shoe, offloading shoe, soft night splint, hard night splint, cast shoe, shoe balancer Non-Adherent Pad Dressing Kit Ankle Support GEL TOE SEPERATOR, GEL BUNION GUARD ,GEL HEEL CUP, GEL CUSHIONS ,BUNION TOE SPREADER,HEEL LINERS Waist Support Arthritis gloves; Compress gloves First Aid Kit Gloves disposable face mask Absorbent gauze products First Aid Bandage Sterile Wound Plaster Wound Dressing; RTD Wound Dressing Cold And Hot Therapy Pack, Heat Pack disposable face mask RTD Wound Dressing; RTD Wound Dressing; DermaBlue Foam; Gentell Blue Foam Dressing; Vitale RTD Wound Dressing; CuraBlue Silver Foam Instant Cold Pack Shin Support,Thigh Support GEL CORN PROTECTORS, GEL TOE PROTECTOR, TOE BANDAGES, TOE WRAPS Pill Box Wipes Alcohol Pad Padded Splint disposable face mask Non-woven Swabs penrose tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2025-06-13
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2020-08-06
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2014-05-08
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2016-03-07
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2015-12-08
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2016-03-07
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2024-08-09
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2018-05-15
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2018-05-15
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2014-05-08
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2014-05-08
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2018-05-15
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-05-08
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-11-21
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2018-05-15
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2015-12-08
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2016-03-07
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2016-11-19
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2023-01-05
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-23
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2014-05-08
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2022-05-24

Official Correspondent

Irene Pang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

SUZHOU SUNMED 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005533873. Last updated year: 2026. Please use registration number 3005533873 when referencing this establishment in official correspondence.