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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 3 of 4

Device	Model / Reference	Registries	Class	Status
BIOTRANS™ Pressure Monitoring Kits	MV3-N ADD ON KIT	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR40 LS3-MV (USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	91062 SINGLE LINE KIT - CHILDREN'S MERCY	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD2755NX-CCF	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BP3 LS3-MV (USA)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR-2448-3-BP2 (USA)	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD2704NCFX-BSI	FDA UDI	Class II	Active
Biosensors Embolectomy Catheter	EL3280	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR2-6012-MV (VA SLC)	FDA UDI	Class II	Unknown
Thermodilution Catheter and Accessories	TD2704NFX (BNS) - CMS USA	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BP3 LS2-S Add-on Kit (USA)	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD2704NCFX-BSI	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	CCF-TRIFURCATED SGL LINE SET-CC91014	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD2755NDFX-BSI	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	CCF ADD ON KIT -CC91092	FDA UDI	Class II	Active
BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables	BT-201 (BIOTRANS II CCF)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	91065 NICU KIT - CHILDREN'S MERCY HOSPI	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR3-4812-3-BP2-S (USA)	FDA UDI	Class II	Unknown
Biosensors Central Venous Catheter Kit	CVR-501-16	FDA UDI	Class II	Active
Biosensors Embolectomy Catheter	EL 1580 (VP CAP)	FDA UDI	Class II	Unknown
Thermodilution Catheter and Accessories	TD1704NX-ARG(497526)	FDA UDI	Class II	Active
Inline Sensor Assembly and Inline Temperature Sensor	INLINE TEMPERATURE SENSOR (ILS-1)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR-3-91077 McALLEN CV KIT	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	PT12 (BNS-W/O LABEL)-USA	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT-72	FDA UDI	Class II	Active
ACCUTRANS™ Disposable Pressure Monitoring System	AT 4812-3	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	DEADENDER PKG/4 WITH CAP (BNS)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT12 (BNS-W/O LABEL)-USA	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR40 LS3-MV (USA)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR40 MV3-N Syringe Kit	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR-3 W/O IFU-BULK PACK (NON-STERILE)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT06	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR 6012-3 DL (USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	PT-36	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR3-6012-3 (USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	91065 NICU KIT - CHILDREN'S MERCY HOSPI	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	PT-60	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR 24-40(USA)	FDA UDI	Class II	Unknown
Thermodilution Catheter and Accessories	TD1704NXC-ARG(497536)	FDA UDI	Class II	Unknown
Biosensors Embolectomy Catheter	EL3380	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR-3 (BNS)-CARDIOMED	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR-4812-3 (CAT#5510219)-GE	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD1702NX-ARG(497523)	FDA UDI	Class II	Unknown
Thermodilution Catheter and Accessories	TD1704NDX-ARG(497539)	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD1704NDX-ARG(497539)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	PT-48	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD2604NX (BNS)-CMS USA	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	CCF-STD SGL LINE MEAN SET-CC91021	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD1704ND-ARG(497521)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	CCF-SWAN SET-CC91011	FDA UDI	Class II	Active

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