Identity
- Trade Name
- PRISMAFLEX SET EUDAMED
- Device Name
- Prismaflex HP-X Set EUDAMED
- Model / Reference
- 114877MDR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07332414201333 EUDAMED
- Basic UDI-DI
- 7332414VA00002937 EUDAMED
- EMDN Code
- C03010101 EXTRACORPOREAL CIRCULATION CIRCUITS 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prismaflex Set by Vantive Health GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7332414VA00002937 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Vantive Health GmbH
- EUDAMED SRN
- CH-MF-000038981
- Authorised Representative
- Vantive S.r.l. IT-AR-000041309
Sources (1)
- EUDAMED 29ae2a77-e061-48a5-9b79-d9a108bfb38a 61 fields · synced Jun 18, 2026