Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013529745

FEI Number

3013529745

Entity Name

JIANGXI BAOERAN BIOMEDICAL SCIENCE & TECHNOLOGY CO.,LTD

City/State/Country

Fuzhou Jiangxi, CN

Establishment Address

No.888 Gaoxin Wu Road, Fuzhou High-Tech Industrial Development Zone, Fuzhou Jiangxi 344000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jiangxi BaoErAn Biomedical Science & Technology Co.,Ltd (Owner Number: 10053499)

Owner / Operator Contact Address

No.888. Gaoxin five Road,, Fuzhou High-Tech Development Zone,, Fuzhou, CN-JX 344000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Single-use Sterile High-pressure Angiographic Syringes and Accessories

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	2025-12-12

Official Correspondent

Li Cai

US Agent Details

Ann Hamilton Ruben Business: Darco International Corporation Email: Ahr@Darcointernational.net Phone: (954) 3808595

Related Public Records

Same Entity

Jiangxi BaoErAn Biomedical Science & Technology 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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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 3013529745. Last updated year: 2026. Please use registration number 3013529745 when referencing this establishment in official correspondence.