Identity
- Trade Name
- FLUOBEAM LS EUDAMED
- Device Name
- FLUOBEAM LS EUDAMED
- Model / Reference
- FBLS EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B475FBLS0 EUDAMED
- Basic UDI-DI
- ++B475FBLSB7 EUDAMED
- Direct Marketing DI
- +B475FBLS0 EUDAMED
- EMDN Code
- Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa 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
Fluobeam Ls 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 | ++B475FBLSB7 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fluoptics Sas
- EUDAMED SRN
- FR-MF-000000403
Sources (1)
- EUDAMED 464dcb7d-31cb-4f41-a4d3-04ad44b811de 61 fields · synced Jun 18, 2026