Identity
- Trade Name
- BiCart 1250 EUDAMED
- Device Name
- BiCart EUDAMED
- Model / Reference
- 955845 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07332414127169 EUDAMED
- Basic UDI-DI
- 7332414VA0000393A EUDAMED
- EMDN Code
- F040201 DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
BiCart 1250 by Vantive Health GmbH — Class IIb — 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 | 7332414VA0000393A | Class IIb | 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 bcc7c54e-25e2-49cf-8472-d8359bbf6fc4 61 fields · synced Jul 14, 2026