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FUJIFILM FDX Visionary CS
EUDAMEDClass IIb (EU MDR)
Ref 95 02 000Model FDX Visionary CSRef 95 01 000Ref 95 02 000; 95 04 000; 95 07 000; 95 09 000Model ARCO FP-SRef 95 01 000; 95 03 000; 95 06 000; 95 08 000
Identity
- Trade Name
- FUJIFILM FDX Visionary CS EUDAMEDFDX Visionary CS EUDAMED
- Model / Reference
- FDX Visionary CS EUDAMED95 02 000 EUDAMED95 01 000 EUDAMEDARCO FP-S EUDAMED95 02 000; 95 04 000; 95 07 000; 95 09 000 EUDAMED95 01 000; 95 03 000; 95 06 000; 95 08 000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186670174 EUDAMED08055186670167 EUDAMED
- Basic UDI-DI
- B-08055186670174 EUDAMEDB-08055186670167 EUDAMED805518667FP-SFH EUDAMED
- Direct Marketing DI
- 08055186670174 EUDAMED08055186670167 EUDAMED
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMEDNetherlands 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
FUJIFILM FDX Visionary CS by A.T.S. Applicazione Tecnologie Speciali s.r.l. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08055186670174 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08055186670174 | Class IIb | Active |
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Manufacturer
- Manufacturer
- A.T.S. Applicazione Tecnologie Speciali s.r.l.
- EUDAMED SRN
- IT-MF-000010734
Sources (6)
- EUDAMED be64e8ea-0717-4383-bb37-be1d2b467555 61 fields · synced Oct 6, 2026
- EUDAMED 42547f26-70b5-4142-a30c-041c7af05693 61 fields · synced May 18, 2026
- EUDAMED 9a305807-e1d3-4c2e-b0a4-380e736b73e2-1 61 fields · synced Jul 9, 2026
- EUDAMED 9a305807-e1d3-4c2e-b0a4-380e736b73e2-2 61 fields · synced Jul 9, 2026
- EUDAMED b52151ab-26ed-4a5f-a21d-0ffcfe9ab733-1 61 fields · synced Jul 13, 2026
- EUDAMED b52151ab-26ed-4a5f-a21d-0ffcfe9ab733-2 61 fields · synced Jul 13, 2026