Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004547763

FEI Number

3004547763

Entity Name

ANJI ANSHEN SURGICAL DRESSINGS CO., LTD.

City/State/Country

Huzhou, Zhejiang, CN

Establishment Address

Tangpu Industrial Park, Anji Economic Development Zone, Huzhou, Zhejiang 313300, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Anji Anshen Surgical Dressings Co., Ltd. (Owner Number: 9076320)

Owner / Operator Contact Address

Tangpu Industrial Park Anji, Economic Development Zone, Huzhou, CN-ZJ 313300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nasopharyngeal airway Nasal strips First Aid Kit Without Drug Adhesive Tape Adhesive Bandage Tourniquet, Nonpneumatic Nonresorbable, Gauze/Sponge For External Use Splint Hydrophilic Wound Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2025-02-14
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-24
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2025-02-14
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2022-08-02
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2005-08-12
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2022-08-02
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2016-01-15
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2022-08-02
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-24
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2016-01-15

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Anji Anshen Surgical Dressings 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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

Similar Registrations

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3036715097	FUI-CHA CO.,LTD.	Taichung City, TW
3017937889	SHAOXING JIANCHENG MEDICAL PRODUCTS CO., LTD.	Shaoxing Zhejiang, CN
3025325119	SENTRONIC INTERNATIONAL CORP.	Taipei, TW
3008436219	JBC CORP	Virginia Beach, VA, US
2936999	Covidien	Lafayette, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004547763. Last updated year: 2026. Please use registration number 3004547763 when referencing this establishment in official correspondence.