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Bioptimal Central Venous Catheter and Catheterization Kit
EUDAMEDClass III (EU MDR)
Ref 25-000023-45Model CVN-402-16
Identity
- Trade Name
- Bioptimal Central Venous Catheter and Catheterization Kit EUDAMED
- Device Name
- Central Venous Catheter and Catheterization Kit EUDAMED
- Model / Reference
- CVN-402-16 EUDAMED25-000023-45 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483510654 EUDAMED
- Basic UDI-DI
- B-08886483510654 EUDAMED
- EMDN Code
- C01020202 CENTRAL VENOUS DOUBLE-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
Category: Central venous catheterization kit, short-term
Bioptimal Central Venous Catheter and Catheterization Kit by Bioptimal International Pte. Ltd. — Class III — MDD — listed in EUDAMED
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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-08886483510654 | 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 10e79cb2-ba8b-4917-94ab-b7a101e94efd 61 fields · synced Jun 18, 2026