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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 2 of 3

Device	Model / Reference	Registries	Class	Status
Bioptimal Central Venous Catheter and Catherization Kit	25-000100-03	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000007-17	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000202-00	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	24-000242-21	EUDAMED	Class III	Active
Bioptimal Embolectomy Catheter	EL1441	EUDAMED	Class IIa	Active
Bioptimal Central Venous Catheter and Catherization Kit	24-000242-23	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000009-24	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000046-48	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000004-87	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000019-42	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000053-15	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000004-89	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	24-000253-01	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000023-24	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000017-52	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000005-28	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000009-58	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000007-34	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000021-62	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000202-02	EUDAMEDFDA UDI	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000046-45	EUDAMED	Class III	Active
Bioptimal Angiographic Kit	22-000890-00	EUDAMED	Class IIa	Active
Bioptimal Embolectomy Catheter	EL3381	EUDAMED	Class IIa	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000025-40	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000070-29	EUDAMED	Class III	Active
Bioptimal Vascular Introducer Kit	24-000025-07	EUDAMED	Class IIa	Active
Bioptimal Thermodilution Catheter and Kits	21-000201-23	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000050-72	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000050-22	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000017-61	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000004-94	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000011-55	EUDAMED	Class III	Active
Bioptimal Bipolar Pacing Catheter	BP-0002-018	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000005-38	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	24-000242-29	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000009-64	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000021-57	EUDAMED	Class III	Active
Bioptimal Embolectomy Catheter	EC-0002-012	EUDAMED	Class IIa	Active
Bioptimal Thermodilution Catheter and Kits	21-000201-15	EUDAMEDFDA UDI	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000004-78	EUDAMED	Class III	Active
Bioptimal Bipolar Pacing Catheter	BP-0002-011	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000011-46	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000015-85	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000046-41	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000053-01	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000011-45	EUDAMED	Class III	Active
Bioptimal Vascular Introducer Kit	24-000026-05	EUDAMED	Class IIa	Active
Bioptimal Thermodilution Catheter and Kits	21-000152-27	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000070-28	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	24-000246-09	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