Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003829571

FEI Number

3003829571

Entity Name

WUXI YUSHOU MEDICAL APPLIANCES CO., LTD

City/State/Country

Wuxi City Jiangsu, CN

Establishment Address

No.115 Nongxinhe Road, Dongbeitang, Xishan District, Wuxi City Jiangsu 214191, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WUXI YUSHOU MEDICAL APPLIANCES CO., LTD (Owner Number: 9080780)

Owner / Operator Contact Address

No.115 Nongxinhe Road, Dongbeitang, Xishan District, WUXI CITY, CN-JS 214191, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

YM70-80 Piston Syringe Multiple

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2014-01-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-01-16
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2026-03-16
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2021-08-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-11-06
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2007-05-31
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2011-01-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-12-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-12-21
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2016-12-25
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-07-26
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2014-01-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-01-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-08-03

Official Correspondent

ZHILING FENG

US Agent Details

Jun Peng Business: P&L Scientific Inc. Email: jpeng@plscientificinc.com Phone: (305) 3456018

Related Public Records

Same Entity

WUXI YUSHOU MEDICAL APPLIANCES 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
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
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003829571. Last updated year: 2026. Please use registration number 3003829571 when referencing this establishment in official correspondence.