Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010370474

FEI Number

3010370474

Entity Name

WUHAN HUAWEI TECHNOLOGY CO., LTD

City/State/Country

Wuhan Hubei, CN

Establishment Address

B-F11-3, Yangluo Port, Huazhong Internation Industrial Park, Wuhan Hubei 430415, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Wuhan huawei technology co., Ltd (Owner Number: 10043381)

Owner / Operator Contact Address

B-F11-3,Yangluo port, Huazhong Internation Industrial Park, Wuhan, CN-HB 430415, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

silk tape;paper tape; zinc oxide adhesive plaster;PU film tape; nonwoven fixing tape roll; band aid tape roll cannula fixing tape, cannula fixing dressing,catheter fixing dressing surgical incise film surgical incise adhesive dressing surgical incise dressing surgical adhesive dressing surgical incise adhesive film Medical Isolation Mask first aid kit, wound dressing kit, surgical kit,bangdage kit, Nursing kit, healthcare kit silicone scar sheet silicone scar patch silicone scar gel sheet face mask bandage; Carboxymethyl hemostatic gauze; Chitosan hemostiatic gauze; Kaolin hemostatic gauze; Zeolite hemostatic gauze Calcium Alginate Dressing Acne patch,blister patch, foot patch,heel patch Hydrogel Dressings, Alginate Dressings, Non-Adherent Dressings; Oil Emulsion Dressing, Petrolatum Dressing Hydrogel wound dressing and burn dressing Biological Wound Dressings, Synthetic Wound Dressings,Film Dressings Island Dressing; Dressing,wound,hydrogel w/out drug and/or biologic, Burn Dressing, Non-Adherent Pad STERILE AND NON-STERILE PADS Vaseline Gauze Swabs, Paraffin Gauze Swabs; Wound Dressing, Transparent Wound Dressing,STERILE AND NON-STERILE DRESSING Hydrocolloid Dressings, Collagen Dressings; Burn Dressing, Burn Gel, Burn Relieve, Calcium Alginate Wound Dressings Sterile Absorbent Compress; Emergency Trauma Dressing, Wound Closures,; Foam Dressings, Growth Factors Isolation Gown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-02-11
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2023-07-18
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-06
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2022-10-25
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2023-07-26
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	2020-04-10
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2022-11-16
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2018-06-13
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2018-12-24
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-10

Official Correspondent

Remey Chi

US Agent Details

James H. Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

Wuhan huawei 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010370474. Last updated year: 2026. Please use registration number 3010370474 when referencing this establishment in official correspondence.