Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014383302

FEI Number

3014383302

Entity Name

YANCHENG HUIDA MEDICAL INSTRUMENTS CO., LTD

City/State/Country

Yancheng Jiangsu, CN

Establishment Address

(No.2, kuiyuan Road) Xuefu Town, Yandu District, Yancheng Jiangsu 224035, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Yancheng Huida Medical Instruments Co., Ltd (Owner Number: 10057346)

Owner / Operator Contact Address

(No.2, kuiyuan Road)Xuefu Town, Yandu District, Yancheng, CN-JS 224035, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cervical Brush without medium or with AMIES, STUART, CARY BLAIR, or viral transport media Plastic or wooden stick, viscose, cotton or Nylon flocked head, Plastic or wooden stick, viscose, cotton or Nylon flocked head, without medium or with AMIES, STUART, CARY BLAIR, or viral transport media Forcep Cutting Board Microscope slide 95 Respirator,Disposable Medical Face Mask 95 Respirator,Disposable Medical Face Mask Disposable surgical blades with/without handle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEE	Brush, Biopsy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-03-11
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-05-11
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2020-05-11
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2025-09-12
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2025-09-11
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2025-03-12
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	2020-04-06
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-06
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2018-03-26

Official Correspondent

Zhipei Yang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Yancheng Huida Medical Instruments 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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
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

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3017178443	Guangzhou Aoqun New Materials Co.,Ltd	Guangzhou Guangdong, CN
1220592	HOBBS MEDICAL, INC.	Stafford Springs, CT, US
2023790	Medical Packaging Corporation	Camarillo, CA, US
1320894	CONMED CORPORATION	Utica, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014383302. Last updated year: 2026. Please use registration number 3014383302 when referencing this establishment in official correspondence.