Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012911667

FEI Number

3012911667

Entity Name

YANCHENG JINGWEI CHEMICALS CO., LTD

City/State/Country

Yancheng Jiangsu, CN

Establishment Address

A13-601/604 Guofei Shangcheng, 14 Middle Qingnian Road, Yancheng Jiangsu 224005, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Yancheng Jingwei Chemicals Co., Ltd (Owner Number: 10055053)

Owner / Operator Contact Address

A13-601/604 Guofei Shangcheng, 14 Middle Qingnian Road, Yancheng, CN-JS 224005, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Slide Storage Box Plastic Embedding Cassette GOWN EXAMINATION NON-SURGICAL , ISOLATION GOWN Glass Test Tube; Plastic Pasteur Pipette; Plastic Test Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2017-05-31
KER	Container, Embedding	Pathology	Class 1	864.3010	2017-05-31
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-11-17
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-11-17
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2017-05-31

Official Correspondent

Bo Zhou

US Agent Details

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

Related Public Records

Same Entity

Yancheng Jingwei Chemicals 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012911667. Last updated year: 2026. Please use registration number 3012911667 when referencing this establishment in official correspondence.