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Bioptimal Central Venous Catheter and Catherization Kit
EUDAMEDClass III (EU MDR)
Ref 25-000053-01Model CV-503-13(EUROPE)
Identity
- Trade Name
- Bioptimal Central Venous Catheter and Catherization Kit EUDAMED
- Device Name
- Central Venous Catheter and Catherization Kit EUDAMED
- Model / Reference
- CV-503-13(EUROPE) EUDAMED25-000053-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483506671 EUDAMED
- Basic UDI-DI
- B-08886483506671 EUDAMED
- EMDN Code
- C01020203 CENTRAL VENOUS MULTI-LUMEN (>2) 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 Catherization 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-08886483506671 | 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 3c8eabc5-e078-43e7-b2ea-3c10b500fdff 61 fields · synced Jun 19, 2026