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Bioptimal Vascular Introducer Kit
EUDAMEDClass IIa (EU MDR)
Ref 24-000026-05Model CPIK 8.5F
Identity
- Trade Name
- Bioptimal Vascular Introducer Kit EUDAMED
- Device Name
- Vascular Introducer Kit EUDAMED
- Model / Reference
- CPIK 8.5F EUDAMED24-000026-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483504738 EUDAMED
- Basic UDI-DI
- B-08886483504738 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-08886483504738 | 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 (1)
- EUDAMED 1cfdf6a0-861d-4f78-8fba-a115c0961427 61 fields · synced Jun 18, 2026