Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040389290

FEI Number

3040389290

Entity Name

HUAIYIN MEDICAL INSTRUMENTS CO., LTD.

City/State/Country

Huai an City Jiangsu, CN

Establishment Address

Factory Building 2, No. 106, Chaoyang West Road, Qingjiangpu District, Huai an City Jiangsu 223001, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Huaiyin Medical Instruments Co., Ltd. (Owner Number: 10093906)

Owner / Operator Contact Address

Factory Building 2, No. 106, Chaoyang West Road, Qingjiangpu District, Huai an City, CN-JS 223001, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterile Disposable Surgical Blade with/without Plastic Handle (Stainless Steel) Sterile disposable surgical blade; Sterile disposable surgical blade with plastic handle Sterile Disposable Surgical Blade with/without Plastic Handle (Carbon Steel)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2025-08-01

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Huaiyin Medical Instruments Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
3014649053	Sterilance Medical (Suzhou) Inc.	Suzhou Jiangsu, CN
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
3009968482	HU-FRIEDY MFG CO., LLC	Des Plaines, IL, US
3016844398	AG MARKETING & DEVELOPMENT GROUP INC DBA AGMD GROUP	Brampton Ontario, CA
3004168759	CENTRAL SURGICAL CO. PVT. LTD.	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040389290. Last updated year: 2026. Please use registration number 3040389290 when referencing this establishment in official correspondence.