Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009114792

FEI Number

3009114792

Entity Name

XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,LTD.

City/State/Country

Xuchang Henan, CN

Establishment Address

No.3 Weilai Road, Industry Cluster District, Yanling County, Area B, Baihua Road East, South Side of Erji river, Industry Cluster District Yanling County, Xuchang Henan 461200, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Xuchang Zhengde Environstar Medical Products Co.,Ltd. (Owner Number: 10037096)

Owner / Operator Contact Address

No.3 Weilai 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

Gauze Elastic Bandage Isolation Gown

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	2012-01-07
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2022-12-08
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2013-08-06
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2012-01-07
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-09
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2012-01-07

Official Correspondent

Ming Chen

US Agent Details

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

Related Public Records

Same Entity

Xuchang Zhengde Environstar Medical Products 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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009114792. Last updated year: 2026. Please use registration number 3009114792 when referencing this establishment in official correspondence.