Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022121596

FEI Number

3022121596

Entity Name

ZHANGJIAGANG HUAWEI MEDICAL TECHNOLOGY CO.LTD.

City/State/Country

ZHANGJIAGANG Jiangsu, CN

Establishment Address

NORTH STREET, DAXIN TOWN, ZHANGJIAGANG Jiangsu 215636, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZHANGJIAGANG HUAWEI MEDICAL TECHNOLOGY CO.LTD. (Owner Number: 10084445)

Owner / Operator Contact Address

NORTH STREET, DAXIN TOWN, ZHANGJIAGANG, CN-JS 215636, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Positioner set Wraps/forearm wraps Wraps/wrist wraps Pressure therapy apparatus;medical brace Pressure therapy apparatus; arm wraps/medical thigh Belt set; sub belt assy Wrapscommercial brace wraps/upperarm Pump assy; aeroguage assy/wrist wrap pump/rav Foam dressing Exucare wraps Hemostatic foam disc/silicone foam Dressing with air bolster Aerobolster absorbent dressing Vein path needle guide Bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2022-02-23
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2022-02-23
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-02-23

Official Correspondent

VICTORIA YAH

US Agent Details

Fanfei Liu Email: U.S.agent@frosatechnology.com Phone: (346) 7358880

Related Public Records

Same Entity

ZHANGJIAGANG HUAWEI MEDICAL 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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Similar Registrations

Registration Number	Establishment Name	Location
3004632523	Eduard Gerlach Gmbh	Luebbecke North Rhine-Westphalia, DE
3038624835	DONGGUAN HEECOOL TECHNOLOGY CO., LTD.	Dongguan Guangdong, CN
3010364377	Flexor SA	Barbera del Valles Barcelona, ES
3016232365	SHENZHEN FOAMTECH CO., LTD	Shenzhen Guangdong, CN
2184046	OSBORN MEDICAL CORPORATION	CENTENNIAL, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022121596. Last updated year: 2026. Please use registration number 3022121596 when referencing this establishment in official correspondence.