Identity
- Trade Name
- SoftPac EUDAMED
- Device Name
- SoftPac Citrate EUDAMED
- Model / Reference
- 115789 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07332414120788 EUDAMED
- Basic UDI-DI
- 7332414VA0000342Y EUDAMED
- EMDN Code
- F040101 DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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 | 7332414VA0000342Y | 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 aca24bdd-a599-4b0b-9a88-f1c4f0c2fd31 61 fields · synced Aug 1, 2026