Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008496528

FEI Number

3008496528

Entity Name

BIOXIN MEDICAL CO., LTD

City/State/Country

Weihai Shandong, CN

Establishment Address

No. 288-13 Shanhai Road, Torch Hi-tech Science Park, Weihai Shandong 264209, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

BIOPTIMAL INTERNATIONAL PTE LTD (Owner Number: 9004883)

Owner / Operator Contact Address

14 Kaki Bukit View, Singapore, SG-04 415950, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bioptimal Pulmonary Artery Monitoring Catheter Safetywedge¿ Relief and Accessories Thermodilution Catheter Biotrans¿ Pressure Monitoring Kits Biotrans¿ Reusable Sensor Base Thermodilution Catheter and Catheter and Accessories Heparin Coated Thermodilution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2026-06-02
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2026-06-02
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2007-11-29
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2010-01-07
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-11-29
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-11-29
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2010-07-26
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-11-29

Official Correspondent

John Yong Ji Min

US Agent Details

Dennis Bassett Business: BIOMEDICAL SALES INTERNATIONAL, INC. Email: dwbassett@cs.com Phone: (513) 2586555

Related Public Records

Same Entity

BIOPTIMAL INTERNATIONAL PTE LTD

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8043983	Bioptimal International Pte. Ltd.	SINGAPORE South East, SG

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Similar Registrations

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3038791046	LIQUET MEDICAL INC.	Glen Allen, VA, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3012931345	Stryker Neurovascular	Salt Lake City, UT, US
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
9616683	TELEFLEX MEDICAL	ANNACOTTY Limerick, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008496528. Last updated year: 2026. Please use registration number 3008496528 when referencing this establishment in official correspondence.