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Bioptimal Vascular Introducer Kit
EUDAMEDClass IIa (EU MDR)
Ref 24-000029-03Model CPIK 8.5F-CROATIARef 24-000019-16Model CPIK8F- EUROPE
Identity
- Trade Name
- Bioptimal Vascular Introducer Kit EUDAMED
- Device Name
- Vascular Introducer Kit EUDAMED
- Model / Reference
- CPIK 8.5F-CROATIA EUDAMED24-000029-03 EUDAMEDCPIK8F- EUROPE EUDAMED24-000019-16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483512481 EUDAMED08886483509368 EUDAMED
- Basic UDI-DI
- B-08886483512481 EUDAMEDB-08886483509368 EUDAMED
- EMDN Code
- C0599 CARDIOVASCULAR INTRODUCER SHEATHS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bioptimal Vascular Introducer Kit by Bioptimal International Pte. Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08886483512481 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bioptimal International PTE. LTD.
- EUDAMED SRN
- SG-MF-000010306
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED c8edc2fb-72a9-4526-b7c5-03c5c1b64695 61 fields · synced Sep 17, 2026
- EUDAMED b3a305e1-2c22-4617-ac98-5a5d8cb43dff 61 fields · synced May 19, 2026