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Bioptimal International Pte. Ltd.

Singapore·SG-MF-000010306

Last updated September 17, 2026

Information

Country: Singapore
Address: 14 Kaki Bukit View, Singapore, Singapore
Website: www.bioptimalg.com/en
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Francis Joey Eduave
EUDAMED SRN: SG-MF-000010306
FDA FEI Number: 3016261803
DUNS Number: —

Catalogue (124)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF)	K252702	FDA 510(k)	Class II	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000011-05	EUDAMED	Class III	Active
Accutrans	22-000948-27	EUDAMED	Class IIa	Active
Bioptimal Thermodilution Catheter and Kits	21-000063-11	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000202-10	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000001-68	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000201-17	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000019-75	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000003-57	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000201-16	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000202-22	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000001-69	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000100-42	EUDAMED	Class III	Active
Bioptimal Bipolar Pacing Catheter	BP-0002-007	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000025-41	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000015-56	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000025-26	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	24-000246-13	EUDAMED	Class III	Active
Accutrans	22-000948-21	EUDAMEDFDA UDI	Class IIa	Active
Bioptimal Central Venous Catheter and Catherization Kit	24-000246-12	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000050-26	EUDAMED	Class III	Active
Bioptimal Bipolar Pacing Catheter	BP-0003-003	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000017-42	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000100-08	EUDAMED	Class III	Active
Biotrans	22-000310-06	EUDAMED	Class IIa	Active
Bioptimal Central Venous Catheter and Catheterization Kit	24-000251-03	EUDAMEDFDA UDI	Class III	Active
Bioptimal Vascular Introducer Kit	24-000029-03	EUDAMED	Class IIa	Active
Bioptimal Bipolar Pacing Catheter	BP-0002-022	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000011-60	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000017-59	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000201-25	EUDAMED	Class III	Active
Bioptimal Vascular Introducer Kit	24-000031-05	EUDAMED	Class IIa	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000015-43	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000100-10	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000011-48	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000021-66	EUDAMED	Class III	Active
Accutrans	22-000948-23	EUDAMED	Class IIa	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000023-33	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000019-21	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000017-80	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000009-45	EUDAMED	Class III	Active
Bioptimal Embolectomy Catheter	EL1681	EUDAMED	Class IIa	Active
Bioptimal Thermodilution Catheter and Kits	21-000153-31	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	24-000246-10	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000019-49	EUDAMED	Class III	Active
Accutrans	22-000948-32	EUDAMED	Class IIa	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000004-99	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000048-75	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000017-27	EUDAMED	Class III	Active
Bioptimal Bipolar Pacing Catheter	BP-0002-005	EUDAMED	Class III	Active

Related Companies

Authorised Representatives

Shanghai International Holding Corp. GmbH(Europe) DE

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Bioptimal International Pte. Ltd. US