Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015009200

FEI Number

3015009200

Entity Name

UNION MEDICAL SHENZHEN CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 603, Building 3, Fantasia MIC Plaza, Nanhai Avenue, Nanshan District, Shenzhen Guangdong 518062, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Union Medical Shenzhen Co., Ltd. (Owner Number: 10058690)

Owner / Operator Contact Address

Room 603, Building 3, Fantasia MIC Plaza, Nanhai Avenue, Nanshan District, Shenzhen, CN-GD 518062, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170279

PMA Number

N/A

All Registered Proprietary Names

Disposable High Pressure 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	2018-10-22

Official Correspondent

Leibo Xin

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

Union Medical Shenzhen Co., Ltd.

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

View Entity Profile →

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015009200. Last updated year: 2026. Please use registration number 3015009200 when referencing this establishment in official correspondence.