Identity
- Trade Name
- TherMax EUDAMED
- Device Name
- TherMax Blood Warmer Disposable EUDAMEDTherMax EUDAMED
- Model / Reference
- 955516MDR EUDAMED955670 EUDAMED955515MDR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07332414202309 EUDAMED07332414125325 EUDAMED07332414202255 EUDAMED
- Basic UDI-DI
- 7332414VA00004433 EUDAMED7332414VA0000112L EUDAMED
- EMDN Code
- Z12090385 HAEMOFILTRATION INSTRUMENTS - CONSUMABLES EUDAMEDZ12090380 HAEMOFILTRATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass 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
TherMax by Vantive Health GmbH — Class IIa — 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 | 7332414VA00004433 | Class IIa | 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 (3)
- EUDAMED 6fda6da3-1ccf-4b05-8291-a077891806b7 61 fields · synced Jul 17, 2026
- EUDAMED 40168242-e8c3-4a80-8824-950d9b2e2ab6 61 fields · synced May 18, 2026
- EUDAMED 99fa72a7-c9f1-4334-a630-52fdc7f24934 61 fields · synced Jul 15, 2026