Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009540572

FEI Number

3009540572

Entity Name

Gushi priMED Medical Products Manufacturing Co., Ltd.

City/State/Country

Gushi County Henan, CN

Establishment Address

Plant 18#, 20# Taiwanese Industry Park, Gushi County Henan 465200, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PRIMED Medical Products Inc. (Owner Number: 9030179)

Owner / Operator Contact Address

200, 2003 - 91 Street SW, EDMONTON, CA-AB T6X 0W8, CA

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
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2014-11-19
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2013-03-13
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2008-07-09
FME	Gown, Examination	General Hospital	Class 1	880.6265	2006-02-17

Official Correspondent

Kam Ching

US Agent Details

Robert Duffy Business: Medical Device Post-Production Services Inc. Email: bob.duffy@mdpps-inc.com Phone: (858) 2318858

Related Public Records

Same Entity

PRIMED Medical Products Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013260641	priMED Jiujiang Medical Products Manufacturing Co., Ltd	Jiujiang Jiangxi, CN
3017229009	PRIMED Medical Products Manufacturing Ltd.	Cambridge Ontario, CA
3020755815	PRIMED Laos Medical Products Manufacturing Sole Co., Ltd.	Vientiane Capital Viangchan (Prefecture), LA
3005599545	PRIMED LIYANG MEDICAL PRODUCTS MANUFACTURING CO., LTD.	Liyang Jiangsu, CN
9615270	PRIMED MEDICAL PRODUCTS INC.	Edmonton Alberta, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009540572. Last updated year: 2026. Please use registration number 3009540572 when referencing this establishment in official correspondence.