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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 2 of 4

Device	Model / Reference	Registries	Class	Status
BIOTRANS™ Pressure Monitoring Kits	LS2 - T SITE ADD-ON KIT	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD2755NDFX-BSI	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	CL1702NX-ARG(497540)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	MV-1	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR-40-LS3-S (USA)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT72M (BNS-W/O LABEL)-USA	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	MED-LOC LOCKING CANNULA-USA	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BP3-LS3-S ADD-ON KIT(USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BP3 LS2-S Add-on Kit (USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR40 MV2-N SYRINGE KIT(USA)	FDA UDI	Class II	Unknown
Thermodilution Catheter and Accessories	TD2704NFX (BNS) - CMS USA	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	NORFOLK CHILDRENS ARTERIAL LINE SET	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD1755NSD-ARG(497531)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT24 (BNS-W/O LABEL)-USA	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	EXTENSION TUBING SET (CCF)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR60-40DL KIT (USA)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	LS2-MV (USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR40 MV3-N	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR-1 W/O IFU (BNS)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR1 (USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	PT24	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR1 (USA)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT-72	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	LS2-MV (USA)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	SBC-3 CANNULA LL WITH 3CC SYRINGE (USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR40 MV2-N SYRINGE KIT(USA)	FDA UDI	Class II	Active
Biosensors Embolectomy Catheter	EL1440 (VP CAP)	FDA UDI	Class II	Unknown
Thermodilution Catheter and Accessories	TD1704NX-ARG(497526)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	CCF MV ADD-ON CLOSED BLOOD DRAW SET -USA	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD1602NX-ARG(497527)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR BIOTRANS DOME W/O FLUSH DEVICE(USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	MV3-N ADD ON KIT	FDA UDI	Class II	Unknown
BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables	BT-201 (CAT#5867983)-GE	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR40 LS2-MV	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	070522RD01 (BNS)-CARDIOMED	FDA UDI	Class II	Active
Biosensors Embolectomy Catheter	EL3260	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT72M (BNS-W/O LABEL)-USA	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	LS2 ADD-ON KIT-USA	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR BIOTRANS DOME W/O FLUSH DEVICE(USA)	FDA UDI	Class II	Active
Biosensors Embolectomy Catheter	EL 1680 (VP CAP)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR W/O IFU-BULK PACK(NON-STERILE)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	91062 SINGLE LINE KIT - CHILDREN'S MERCY	FDA UDI	Class II	Unknown
Biosensors Embolectomy Catheter	EL 1480 (VP CAP)	FDA UDI	Class II	Unknown
Biosensors Embolectomy Catheter	EL 1780 (VP CAP)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BP3-LS3-S ADD-ON KIT(USA)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT24	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	MV2-T SITE ADD ON KIT (USA)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	SBC-3 CANNULA LL WITH 3CC SYRINGE (USA)	FDA UDI	Class II	Active
BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables	CM-BT201 (MEDTRANS II)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR2-6012-MV (VA SLC)	FDA UDI	Class II	Active

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