Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007084575

FEI Number

3007084575

Entity Name

ShanDong WeiGao Group Medical Polymer Co., Ltd

City/State/Country

Weihai Shandong, CN

Establishment Address

No.1 Weigao Road, Torch Hi-tech Science Park, Weihai Shandong 264210, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Weigao Group Company Limited (Owner Number: 10025293)

Owner / Operator Contact Address

No.1 Weigao Road, Torch Hi-tech Science Park, 264210 Weihai, Shandong Province, PEOPLE'S REPUBLIC OF CHINA, Weihai, CN-SD 264210, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterile High Pressure Angiographic Syringes for Single Use Disposable Angiographic Syringes Patient Safe Luer Cap ORAL/ENTERAL SYRINGE Patient Safety Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2010-06-11
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2019-04-12
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-03-08
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2011-12-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-07-24

Official Correspondent

Lina Liu

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Weigao Group Company Limited

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007616112	Weihai Jierui Medical Products Co., Ltd.	WEIHAI Shandong, CN
3006562124	FOOSIN MEDICAL SUPPLIES INC.LTD	WEIHAI Shandong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

Similar Registrations

Registration Number	Establishment Name	Location
3003786696	IMAXEON PTY LTD	Rydalmere New South Wales, AU
1518293	Liebel-Flarsheim Company LLC	Cincinnati, OH, US
9616990	NEMOTO KYORINDO CO., LTD.	KAWAGUCHI-SHI Saitama, JP
3015309643	Merit Medical UK Limited	Earley Reading, GB
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007084575. Last updated year: 2026. Please use registration number 3007084575 when referencing this establishment in official correspondence.