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FUJIFILM FDX Visionary CS
EUDAMEDClass IIb (EU MDR)
Ref 95 05 000Model FDX Visionary CS
Identity
- Trade Name
- FUJIFILM FDX Visionary CS EUDAMED
- Model / Reference
- FDX Visionary CS EUDAMED95 05 000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186670150 EUDAMED
- Basic UDI-DI
- B-08055186670150 EUDAMED
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS 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
FUJIFILM FDX Visionary CS by A.T.S. Applicazione Tecnologie Speciali s.r.l. — 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-08055186670150 | Class IIb | Active |
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Manufacturer
- Manufacturer
- A.T.S. Applicazione Tecnologie Speciali s.r.l.
- EUDAMED SRN
- IT-MF-000010734
Sources (1)
- EUDAMED eaf6cb1c-2e0a-4fc1-ba12-4a4593c7300a 61 fields · synced Jun 19, 2026