Identity
- Trade Name
- BiCart Select combi-pak EUDAMED
- Device Name
- Bicart Select combi-pak EUDAMED
- Model / Reference
- 955848 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 37332414127191 EUDAMED
- Basic UDI-DI
- 7332414VA00003838 EUDAMED
- Unit of Use DI
- 77332414127526 EUDAMED
- EMDN Code
- F040201 DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER EUDAMED
Classification
- Device Class
- Class IIb 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 Select combi-pak 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 | 7332414VA00003838 | 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 13c28430-d6eb-4c11-b05f-661e645be2f6 61 fields · synced Jul 15, 2026