Identity
- Trade Name
- AK 98 EUDAMED
- Device Name
- AK 98 EUDAMED
- Model / Reference
- 956011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07332414201616 EUDAMED
- Basic UDI-DI
- 7332414VA0000012H EUDAMED
- EMDN Code
- Z12090201 HAEMODIALYSIS EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ak 98 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 | 7332414VA0000012H | 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 7f223ca8-fc79-4e84-b4d7-d49e700d72aa 61 fields · synced Jul 11, 2026