Identity
- Trade Name
- RAFALE BDR 32 EUDAMED
- Device Name
- Mobile radiologic units EUDAMED
- Model / Reference
- 10500502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053307590844 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 Bdr 32 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 0b54cf6d-6880-400b-8f96-aaa482ca036b 61 fields · synced Jul 10, 2026