Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005599545

FEI Number

3005599545

Entity Name

PRIMED LIYANG MEDICAL PRODUCTS MANUFACTURING CO., LTD.

City/State/Country

Liyang Jiangsu, CN

Establishment Address

No. 88-8, Huashi Road, Daitou Town Industrial Park,, Liyang Jiangsu 213311, 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

PRIMED Sterilization Wrap PRIMAGARD PRIMASOFT PRIMED Surgical Masks PRIMED Procedure Masks PRIMED Sterilization Wrap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2013-01-18
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-08-27
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2013-03-13
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-08-19
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-11-18
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2000-12-12
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-12-13
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2002-01-09
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-09-11
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2014-11-19

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
3009540572	Gushi priMED Medical Products Manufacturing Co., Ltd.	Gushi County Henan, CN
9615270	PRIMED MEDICAL PRODUCTS INC.	Edmonton Alberta, CA

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

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3005090771	HUBEI WEIKANG PROTECTIVE PRODUCTS CO.LTD	XIANTAO Hubei, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005599545. Last updated year: 2026. Please use registration number 3005599545 when referencing this establishment in official correspondence.