Identity
- Device Name
- FLUOBEAM LM system EUDAMED
- Model / Reference
- CS_FBLM EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B475CSFBLMS/CL0 EUDAMED
- Basic UDI-DI
- ++B475CSFBLMXC EUDAMED
- EMDN Code
- Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- FLUOBEAM LM including FLUOSOFT LM is indicated to visualize on a screen the flow, the distribution and/ or the accumulation of Indocyanine green (ICG) before, during and after surgery for the indications such as: • visualization of blood flow, • visualization of lymph flow, • visualization and identification of bile ducts during hepatobiliary surgery, • visualization and detection of primary liver tumors and/or hepatic metastases. FLUOBEAM LM including FLUOSOFT LM is indicated to facilitate the visualization of parathyroid glands by auto-fluorescence (natural fluorescence without ICG injection) during thyroid and parathyroid surgeries. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
FLUOBEAM LM system 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 | ++B475CSFBLMXC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fluoptics Sas
- EUDAMED SRN
- FR-PR-000002882
Sources (1)
- EUDAMED 57837dbe-0cef-4745-801f-0f10fe3eabaf 61 fields · synced May 23, 2026