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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 3 of 3

Device	Model / Reference	Registries	Class	Status
Bioptimal Central Venous Catheter and Catherization Kit	24-000246-11	EUDAMED	Class III	Active
Bioptimal Angiographic Kit	22-000217-06	EUDAMED	Class IIa	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000015-80	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000048-70	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000100-27	EUDAMED	Class III	Active
Bioptimal Embolectomy Catheter	23-000006-18	EUDAMED	Class IIa	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000015-55	EUDAMED	Class III	Active
Bioptimal Bipolar Pacing Catheter	BP-0002-021	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000048-74	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000021-74	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000009-80	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000100-01	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000023-38	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000021-12	EUDAMED	Class III	Active
Bioptimal Thermodilution Catheter and Kits	21-000048-87	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000021-64	EUDAMED	Class III	Active
Bioptimal Embolectomy Catheter	EL1481	EUDAMED	Class IIa	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000025-63	EUDAMED	Class III	Active
Biotrans	22-000310-07	EUDAMED	Class IIa	Active
Bioptimal Thermodilution Catheter and Kits	21-000009-68	EUDAMED	Class III	Active
Accutrans	22-000948-22	EUDAMED	Class IIa	Active
Bioptimal Central Venous Catheter and Catherization Kit	25-000070-01	EUDAMED	Class III	Active
Bioptimal Bipolar Pacing Catheter	BP-0002-020	EUDAMED	Class III	Active
Bioptimal Central Venous Catheter and Catheterization Kit	25-000023-45	EUDAMED	Class III	Active

Related Companies

Authorised Representatives

Shanghai International Holding Corp. GmbH(Europe) DE

Importers

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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