XUCHANG ZHENDE SURGICAL DRESSING CO.,LTD.

FDA Device Registration & Listing · Xuchang Henan, CN · Registration 3009526454

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009526454
FEI Number
3009526454
Entity Name
XUCHANG ZHENDE SURGICAL DRESSING CO.,LTD.
City/State/Country
Xuchang Henan, CN
Establishment Address
No.1 Jinhui Road, Industry Cluster District, Yanling County, Area A, Baihua Road East, South Side of Erji river, 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
Xuchang Zhende Surgical Dressing Co.,Ltd. (Owner Number: 10039511)
Owner / Operator Contact Address
No.1 Jinhui Road, Industry Cluster District, Yangling County, Xuchang, CN-HA 461200, CN
Initial Importer Flag
N
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
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2020-11-25
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2021-06-16
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2020-09-02
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2020-10-15
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2012-01-17
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2012-01-17

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 Zhende Surgical Dressing 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
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09
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 3009526454. Last updated year: 2026. Please use registration number 3009526454 when referencing this establishment in official correspondence.
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