Identity
- Trade Name
- AQUATHERM EUDAMED
- Device Name
- AQUATHERM EUDAMED
- Model / Reference
- AQUATHERM EUDAMED7674 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053847360099 EUDAMED
- Basic UDI-DI
- B-08053847360099 EUDAMED
- EMDN Code
- Z12040208 BODY THERMOREGULATION EQUIPMENT 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aquatherm by GINEVRI srl — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08053847360099 | Class IIb | Active |
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Manufacturer
- Manufacturer
- GINEVRI srl
- EUDAMED SRN
- IT-MF-000034527
Sources (1)
- EUDAMED 641789a0-8bce-446c-8a42-d953e5df3a28 61 fields · synced Jun 19, 2026