Bioptimal International PTE LTD

14 Kaki Bukit View, Singapore, Singapore, 415950

26 devices* 33 registrations
✕ Canada (Health Canada)
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Devices

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Showing 1–20 of 26 devices

Device Name US UK CA AU EU
Accutrans Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Angiographic kit Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
Bioptimal Angiographic Kit Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Bioptimal Bipolar Pacing Catheter Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Bioptimal Central Venous Catheter and Catherization Kit Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Bioptimal Central Venous Catheter and Catheterization Kit Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Bioptimal Embolectomy Catheter Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Bioptimal Thermodilution Catheter and Kits Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Bioptimal Vascular Introducer Kit Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Biosensors Flow Directed Polyurethane Thermodilution Catheter Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
Biosensors Flow Directed Polyurethane Thermodilution Catheter Pacing Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
Biotrans Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Bipolar Pacing Catheter Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Central Venous Catheter and Catheterization Kit Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Embolectomy Catheter Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Introducer Set Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
Pressure Monitoring Systems and Kits - ACCUTRANS Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Pressure Monitoring Systems and Kits - BIOTRANS Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Pressure Monitoring Systems and Kits -CATRANS Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
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