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BIOPTIMAL INTERNATIONAL PTE. LTD.

Last updated May 30, 2026

Part of Bioptimal International Pte. Ltd.

What BIOPTIMAL INTERNATIONAL PTE. LTD. makes

BioOptimal International Pte. Ltd. manufactures invasive blood pressure monitoring systems, including reusable external transducers and disposable transducer sets. Their portfolio also includes pulmonary artery balloon catheters, both electrical and non-electrical, for hemodynamic monitoring. Thrombectomy balloon catheters and short-term central venous catheterization kits are part of their product line, designed for critical care and interventional procedures.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: biosensors.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +6562135777
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 595182247

Catalogue (197)

Page 4 of 4

Device	Model / Reference	Registries	Class	Status
Thermodilution Catheter and Accessories	TD1755NSD-ARG(497531)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	CCF-QUAD CUSTOM SET-CC91015	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR-3 (BNS)-CARDIOMED	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR-40-LS3-S (USA)	FDA UDI	Class II	Unknown
Biosensors Embolectomy Catheter	EL 1580 (VP CAP)	FDA UDI	Class II	Active
BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables	BT-201 (BIOTRANS II STRUCTURAL PACK)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	LS2 ADD-ON KIT-USA	FDA UDI	Class II	Active
BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables	CM-BT201 (MEDTRANS II)	FDA UDI	Class II	Active
Biosensors Embolectomy Catheter	EL3280	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT06M (BNS-W/O LABEL)-USA	FDA UDI	Class II	Unknown
Biosensors Embolectomy Catheter	EL 1480 (VP CAP)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR 6012-3(USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	CCF-CARDIO ICU TRI-FUR KIT CC91039	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT-60	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR-2448-3-BP2 (USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	CHKD TRIPLE KIT-USA	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD1755ND-ARG(497520)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	CHKD TRIPLE KIT-USA	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR-30 (N/S & BULK PACK)-CARDIOMED	FDA UDI	Class II	Unknown
Biosensors Embolectomy Catheter	EL 1680 (VP CAP)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	LS2 - T SITE ADD-ON KIT	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	91063 DUAL PRESSURE KIT - CHILDREN'S MER	FDA UDI	Class II	Active
Biosensors Embolectomy Catheter	EL 1780 (VP CAP)	FDA UDI	Class II	Unknown
Central Venous Catheter Kit	CV-802-20	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR-3(USA)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR-3(USA)	FDA UDI	Class II	Unknown
Thermodilution Catheter and Accessories	TD1704ND-ARG(497521)	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD1704NDC-ARG(497534)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR 24-40(USA)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR60-40DL KIT (USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR2-6012-3 (USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	SHEATHED SYRINGE ADD-ON KIT (VA SLC)	FDA UDI	Class II	Unknown
Thermodilution Catheter and Accessories	TD2704NXF-BSI	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR40 LS2-MV	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD2704NXF-BSI	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	CCF-SINGLE LINE ADD-ON SET-CC91013	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	NORFOLK CHILDRENS ARTERIAL LINE SET	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR40 MV3-N Syringe Kit	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	COVERED NEEDLELESS CANNULA (USA)	FDA UDI	Class II	Active
Biosensors Embolectomy Catheter	EL1440 (VP CAP)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR 6012-3 DL (USA)	FDA UDI	Class II	Active
Biosensors Embolectomy Catheter	EL3380	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD1704NXC-ARG(497536)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR-30 (N/S & BULK PACK)-CARDIOMED	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR-3-91077 McALLEN CV KIT	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD1604ND-ARG(497537)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR40 MV3-N	FDA UDI	Class II	Unknown

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