Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003967959

FEI Number

3003967959

Entity Name

ANJI HUIFENG SURGICAL DRESSINGS CO., LTD.

City/State/Country

ANJI COUNTY Zhejiang, CN

Establishment Address

XIAOSHU INDUSTRIAL ZONE, ANJI COUNTY Zhejiang 313307, CN

Establishment Type(s)

Reprocess Single-Use Device,Remanufacture Medical Device,Sterilize Medical Device for Another Party (Contract Sterilizer),Foreign Private Label Distributor,Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

ANJI HUIFENG SURGICAL DRESSINGS CO., LTD. (Owner Number: 9055309)

Owner / Operator Contact Address

XIAOSHU INDUSTRIAL ZONE, ANJI COUNTY, CN-ZJ 313307, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FIBER, MEDICAL, ABSORBENT Bandage Cast Shield, protective, personnel MASK Non-surgical gown Bandage,Elastic BAND OR BELT, PELVIC SUPPORT STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2003-03-03
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2020-04-01
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-04-01
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2020-05-19
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-01
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2003-03-25
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2021-05-20
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2022-09-20

Official Correspondent

JIANG XIAO

US Agent Details

Jie TAn Business: Welmed, Inc Email: tanjie@welmed.us Phone: (847) 8308312

Related Public Records

Same Entity

ANJI HUIFENG SURGICAL DRESSINGS CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003967959. Last updated year: 2026. Please use registration number 3003967959 when referencing this establishment in official correspondence.