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Bioptimal Central Venous Catheter and Catheterization Kit
EUDAMEDClass III (EU MDR)
Ref 25-000007-34Model CVN-401-20
Identity
- Trade Name
- Bioptimal Central Venous Catheter and Catheterization Kit EUDAMED
- Device Name
- Central Venous Catheter and Catheterization Kit EUDAMED
- Model / Reference
- CVN-401-20 EUDAMED25-000007-34 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483531444 EUDAMED
- Basic UDI-DI
- B-08886483531444 EUDAMED
- EMDN Code
- C01020201 CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Greece 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bioptimal Central Venous Catheter and Catheterization Kit by Bioptimal International Pte. Ltd. — Class III — MDD — listed in EUDAMED
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-08886483531444 | Class III | 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 022e2189-a1da-4c5b-8be2-ab5ef0133ff3 61 fields · synced Jun 18, 2026