Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004859153

FEI Number

3004859153

Entity Name

HUAIAN ANGEL MEDICAL INSTRUMENT CO., LTD

City/State/Country

Huaian Jiangsu, CN

Establishment Address

19 East Zhuhai Road, Huaian Jiangsu 223001, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Huaian Angel Medical Instrument Co., Ltd (Owner Number: 10042862)

Owner / Operator Contact Address

19 East Zhuhai Road, Huaian, CN-JS 223001, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wound Drainage Set Stainless steel Trocar SURGICAL APPAREL Disposable Surgical Blades KN95 KN95 Medical mask (Flat type) Medical protective clothing Sterile Urinary Drainage Bags SPLINTER REMOVER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCI	Trocar, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2014-06-19
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-15
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-01-07
QKU	Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)	Unknown	Class N	N/A	2021-02-24
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	2021-02-24
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-24
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-24
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-01-10
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2022-09-13

Official Correspondent

No official correspondent registered.

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Huaian Angel Medical Instrument 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

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
3008902714	GARISH APPARELS	Wazirabad Punjab, PK
8040233	QSA SURGICAL (PVT) LTD.	SIALKOT Punjab, PK
9611283	DIMEDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3014615697	AMNOTEC INTERNATIONAL MEDICAL GMBH	Neuhausen ob Eck Baden-Wurttemberg, DE
9710524	ULTIMATE MEDICAL PRODUCTS LTD.	SHARJAH Ash Shariqah, AE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004859153. Last updated year: 2026. Please use registration number 3004859153 when referencing this establishment in official correspondence.