Identity
- Trade Name
- FLUOSOFT EUDAMED
- Device Name
- FLUOSOFT EUDAMED
- Model / Reference
- FS-CL EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B475FS-CL0 EUDAMED
- Basic UDI-DI
- ++B475FS800W4 EUDAMED
- EMDN Code
- Z119082 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
Fluosoft by Fluoptics Sas — Class IIa — 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 | ++B475FS800W4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fluoptics Sas
- EUDAMED SRN
- FR-MF-000000403
Sources (1)
- EUDAMED cc90eae0-f5ab-49fc-aa47-e223c9ae08c6 61 fields · synced Jun 18, 2026