Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013919644

FEI Number

3013919644

Entity Name

HENAN ZHENDE MEDICAL PRODUCTS CO., LTD

City/State/Country

Xuchang Henan, CN

Establishment Address

Baihua Road West, North Side of Jinhui Road, Industry Cluster District, Yanling County, Xuchang Henan 461200, CN

Establishment Type(s)

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

Owner / Operator

Henan Zhende Medical Products Co., Ltd (Owner Number: 10055799)

Owner / Operator Contact Address

Baihua Road West, North Side of Jinhui Road, Industry Cluster District, Yanling County, Xuchang, CN-HA 461200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2019-01-15
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2019-08-04
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2017-12-13

Official Correspondent

Guoliu Zhao

US Agent Details

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

Related Public Records

Same Entity

Henan Zhende Medical Products 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 3013919644. Last updated year: 2026. Please use registration number 3013919644 when referencing this establishment in official correspondence.