Identity
- Trade Name
- RAFALE EUDAMED
- Device Name
- Mobile radiologic units EUDAMED
- Model / Reference
- 10500652 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053307590790 EUDAMED
- Basic UDI-DI
- 805330759APP.RXMOBILIVV EUDAMED
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS 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
Rafale by Technix S.p.A. — 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 | 805330759APP.RXMOBILIVV | Class IIb | Active |
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Manufacturer
- Manufacturer
- Technix S.p.A.
- EUDAMED SRN
- IT-MF-000007797
Sources (1)
- EUDAMED 59f0d355-8ea7-474c-9580-0f7ea752cd32 61 fields · synced Jun 19, 2026