Identity
- Trade Name
- SoftPac EUDAMED
- Device Name
- SoftPac EUDAMED
- Model / Reference
- 955735 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07332414126247 EUDAMED
- Basic UDI-DI
- 7332414VA00003532 EUDAMED
- EMDN Code
- F040101 DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
SoftPac 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 | 7332414VA00003532 | 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 72e8c23e-0e33-4403-9b9b-c0022db5aedc 61 fields · synced Jul 30, 2026