Identity
- Trade Name
- EVO R+ FP EUDAMED
- Device Name
- Mobile equipment for radioscopy and radiography EUDAMED
- Model / Reference
- 8S-5-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053307590684 EUDAMED
- Basic UDI-DI
- 805330759STATIVIW7 EUDAMED
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC 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
Evo R+ Fp 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 | 805330759STATIVIW7 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Technix S.p.A.
- EUDAMED SRN
- IT-MF-000007797
Sources (1)
- EUDAMED 05862832-dad1-4e16-a943-d33e424ca2e4 61 fields · synced Jun 18, 2026