Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043983

FEI Number

3016261803

Entity Name

Bioptimal International Pte. Ltd.

City/State/Country

SINGAPORE South East, SG

Establishment Address

14 Kaki Bukit View, SINGAPORE South East 415950, SG

Establishment Type(s)

Manufacture Medical Device

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

K002786

PMA Number

N/A

All Registered Proprietary Names

Bioptimal Embolectomy Catheter Inline Sensor Assembly and Accutrans¿ Disposable Pressure Monitoring System Silicon Foley Catheter Bioport System Bioptimal Bipolar Pacing Catheter Biotrans¿ Reusable Sensor Base Bioptimal Pulmonary Artery Monitoring Catheter Catheter and Accessories Heparin Coated Thermodilution Bioptimal Central Venous Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2007-11-29
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-11-29
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-11-29
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2020-09-13
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-11-29
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2025-06-16
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-11-29
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2026-06-02
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2026-06-02
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-11-29
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-11-29

Official Correspondent

No official correspondent registered.

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
3008496528	BIOXIN MEDICAL CO., LTD	Weihai Shandong, CN

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043983. Last updated year: 2026. Please use registration number 8043983 when referencing this establishment in official correspondence.