Jiangsu Xuhe Medical Technology Co., Ltd.

FDA Device Registration & Listing · Zhangjiagang City, Jiangsu, CN · Registration 3017937325

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
3017937325
FEI Number
3017937325
Entity Name
Jiangsu Xuhe Medical Technology Co., Ltd.
City/State/Country
Zhangjiagang City, Jiangsu, CN
Establishment Address
No.98 Renmin Road, Changfeng, Leyu Town, Zhangjiagang City, Jiangsu 215600, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Jiangsu Xuhe Medical Technology Co., Ltd. (Owner Number: 10080186)
Owner / Operator Contact Address
No.98 Renmin Road, Changfeng, Leyu Town, Zhangjiagang City,, CN-JS 215600, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Surgical Drape Exempt Table and attachments, operating-room Stockinettes

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2021-02-01
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2022-05-20
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2021-01-18
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2021-01-18
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2021-02-01
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2021-01-18
FQM Bandage, Elastic General Hospital Class 1 880.5075 2024-04-18
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2021-02-01

Official Correspondent

Su Jie

US Agent Details

ZHENG XU Email: cathygeng2007@gmail.com Phone: (248) 5508758

Related Public Records

Same Entity

Jiangsu Xuhe Medical Technology 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
K914369 Deroyal Industries, Inc. QUALTEX MAGNETIC INSTRUMENT DRAPE 1991-12-02
K812809 Abco Dealers, Inc. STERILE ADHERENT DRAPES 1981-11-06
K910084 Biocor Medical, Inc. SURGICAL DRAPE 1991-03-19
K812396 Northwest Surgical Concepts, Inc. ARTHRO-PREP REST 1981-11-20

Similar Registrations

Registration Number Establishment Name Location
3030954512 MMI NORTH AMERICA, INC. Jacksonville, FL, US
1836161 ASPEN SURGICAL PRODUCTS, INC. Caledonia, MI, US
2022435 Sterigenics U.S., LLC Tustin, CA, US
2648727 CUSTOMED, INC. Fajardo, PR, US
1061124 Sterigenics U.S., LLC Charlotte, NC, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017937325. Last updated year: 2026. Please use registration number 3017937325 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.