Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026309985

FEI Number

3026309985

Entity Name

ZHIDE MINGCHUANG BIOTECHNOLOGY (WUXI) CO., LTD.

City/State/Country

Wuxi Jiangsu, CN

Establishment Address

Room 201, Building C, Xingye Building, NO.97-1 Linghu Avenue, Xinwu District,, Wuxi Jiangsu 214028, CN

Establishment Type(s)

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

Owner / Operator

Zhide Mingchuang Biotechnology (Wuxi) Co., LTD. (Owner Number: 10091571)

Owner / Operator Contact Address

Room 201, Building C, Xingye Building, NO.97-1 Linghu Avenue, Xinwu District,, Wuxi, CN-JS 214028, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PFQ	Mmp-9 Test System	Clinical Chemistry	Class 1	862.1540	2024-10-16

Official Correspondent

JING LI

US Agent Details

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

Related Public Records

Same Entity

Zhide Mingchuang Biotechnology (Wuxi) Co., LTD.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026309985. Last updated year: 2026. Please use registration number 3026309985 when referencing this establishment in official correspondence.