Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007480628

FEI Number

3007480628

Entity Name

Jiangsu Huida Medical Instruments Co., Ltd

City/State/Country

Yancheng Jiangsu, CN

Establishment Address

West Industrial Park Yandong, Yancheng Jiangsu 224050, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Huida Medical Instruments Co., Ltd. (Owner Number: 10035865)

Owner / Operator Contact Address

West Industrial Park, Yandong, Yancheng, CN-JS 224050, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Plastic Embedding Cassette Surtrace Bio I Cassettes Surtrace Biopsy I Cassettes Sterile Transport Tube Coclue Microscope Slides, Coclue Plus Microscope Slides, Microscope slides, Microscope slide (Adhesive) Glass Disposable Culture Tube Plastic Test Tube Plastic Pasteur Pipette Glass Test Tube Nonresorbable gauze Microscope coverslips Slide Storage Box

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KER	Container, Embedding	Pathology	Class 1	864.3010	2015-03-24
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2020-06-25
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2011-03-29
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2012-12-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-09-26
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2011-03-29
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2015-04-23

Official Correspondent

Cathy Yin

US Agent Details

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

Related Public Records

Same Entity

Jiangsu Huida 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-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.

Similar Registrations

Registration Number	Establishment Name	Location
2518071	POLYSCIENCES, INC.	WARRINGTON, PA, US
3013530901	HANGZHOU ROLLMED CO.,LTD.	Hangzhou Zhejiang, CN
1055757	General Data Healthcare	Cincinnati, OH, US
3010420046	CITOTEST Labware Manufacturing CO., LTD.	Haimen Jiangsu, CN
3003701178	SIAM INTERMAGNATE CO., LTD.	BANGKOK Krung Thep Maha Nakhon, TH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007480628. Last updated year: 2026. Please use registration number 3007480628 when referencing this establishment in official correspondence.