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BIOPTIMAL INTERNATIONAL PTE. LTD.

Last updated May 30, 2026

Part of Bioptimal International Pte. Ltd.

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 1 of 4

Device	Model / Reference	Registries	Class	Status
BIOTRANS™ Pressure Monitoring Kits	BTR 6012-3(USA)	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD1602NX-ARG(497527)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT12	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR-1 W/O IFU (BNS)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	SHEATHED SYRINGE ADD-ON KIT (VA SLC)	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD1704NDC-ARG(497534)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	DEADENDER PKG/4 WITH CAP (BNS)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	91063 DUAL PRESSURE KIT - CHILDREN'S MER	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	CCF-ICU ADD-ON KIT-CC91038	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	MED-LOC LOCKING CANNULA-USA	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR-6012-MV (VA SLC)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR2-6012-3 (USA)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	CCF-ICU TRIFURCATED KIT-CC91037	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR40 LS2-S (USA)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	MV2-T SITE ADD ON KIT (USA)	FDA UDI	Class II	Unknown
Thermodilution Catheter and Accessories	TD1604ND-ARG(497537)	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD1702NX-ARG(497523)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT-36	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	CCF-LEFT HEART SET-CC91010	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT06 (BNS-W/O LABEL)-USA	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT12	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	PT06 (BNS-W/O LABEL)-USA	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	PT06	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	COVERED NEEDLELESS CANNULA (USA)	FDA UDI	Class II	Unknown
Thermodilution Catheter and Accessories	CL1702NX-ARG(497540)	FDA UDI	Class II	Unknown
BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables	BT-201 (BIOTRANS II STRUCTURAL PACK)	FDA UDI	Class II	Unknown
Biosensors Embolectomy Catheter	EL3260	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR W/O IFU-BULK PACK(NON-STERILE)	FDA UDI	Class II	Active
Embolectomy Catheter	EL3340	FDA UDI	Class II	Active
Inline Sensor Assembly and Inline Temperature Sensor	INLINE TEMPERATURE SENSOR (ILS-1)	FDA UDI	Class II	Active
Central Venous Catheter Kit	CV-501-16	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD1755ND-ARG(497520)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR-3 W/O IFU-BULK PACK (NON-STERILE)	FDA UDI	Class II	Unknown
Thermodilution Catheter and Accessories	TD2602NXF-MERIT(EUROPE)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR GREEN- CCF	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR3-6012-3 (USA)	FDA UDI	Class II	Active
BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables	BT-201 (BIOTRANS II CCF)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR40 LS2-S (USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BTR-6012-MV (VA SLC)	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	BTR3-4812-3-BP2-S (USA)	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD2755NX-CCF	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	PT24(BNS)-USA	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	3-WAY STOPCOCK WHITE PKG	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	PT06M (BNS-W/O LABEL)-USA	FDA UDI	Class II	Active
Thermodilution Catheter and Accessories	TD2604NX (BNS)-CMS USA	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	PT-48	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	BP3 LS3-MV (USA)	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	3-WAY STOPCOCK WHITE PKG	FDA UDI	Class II	Active
BIOTRANS™ Pressure Monitoring Kits	MV-1	FDA UDI	Class II	Unknown
BIOTRANS™ Pressure Monitoring Kits	CCF-MEAN SET-CC91016	FDA UDI	Class II	Active

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