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Bioptimal Central Venous Catheter and Catherization Kit
EUDAMEDClass III (EU MDR)
Ref 25-000009-64Model CVN-501-20 (Europe)
Identity
- Trade Name
- Bioptimal Central Venous Catheter and Catherization Kit EUDAMED
- Device Name
- Central Venous Catheter and Catherization Kit EUDAMED
- Model / Reference
- CVN-501-20 (Europe) EUDAMED25-000009-64 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483510647 EUDAMED
- Basic UDI-DI
- B-08886483510647 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
Category: Central venous catheterization kit, short-term
Bioptimal Central Venous Catheter and Catherization 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-08886483510647 | 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 8fef0e24-b3a0-4106-94d8-4eae11ac3f1b 61 fields · synced Jun 18, 2026