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FLUOBEAM 800 system
EUDAMEDClass IIa (EU MDR)
Ref CS_FB800_PC_ARef CS_FB800_PCRef FB800-CLRef CS_FB800_DURef CS_FB800_A
Identity
- Trade Name
- FLUOBEAM 800 EUDAMED
- Device Name
- FLUOBEAM 800 system EUDAMEDFLUOBEAM 800 EUDAMED
- Model / Reference
- CS_FB800_PC_A EUDAMEDCS_FB800_PC EUDAMEDFB800-CL EUDAMEDCS_FB800_DU EUDAMEDCS_FB800_A EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B475CSFB800PCA/CL0 EUDAMED+B475CSFB800PCS/CL0 EUDAMED+B475FB800CL0 EUDAMED+B475CSFB800DU/CL0 EUDAMED+B475CSFB800A/CL0 EUDAMED
- Basic UDI-DI
- ++B475CSFB800NK EUDAMED++B475FB800SD EUDAMED
- Direct Marketing DI
- +B475FB800CL0 EUDAMED
- EMDN Code
- Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
- Medical Purpose
- FLUOBEAM 800 including FLUOSOFT 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 800 including FLUOSOFT 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
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 800 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 | ++B475CSFB800NK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fluoptics Sas
- EUDAMED SRN
- FR-PR-000002882
Sources (5)
- EUDAMED 3b5e32b8-9f45-49ec-829b-c1842df88524 61 fields · synced Jul 24, 2026
- EUDAMED f28c1c3c-b9b2-4f48-ac70-2f9414f2ef19 61 fields · synced May 16, 2026
- EUDAMED 59e5fb4d-9f50-4b5b-a3d3-77479052e3da 61 fields · synced May 18, 2026
- EUDAMED 92d5400b-c370-4721-8ad7-d556b542d570 61 fields · synced May 18, 2026
- EUDAMED 2983b1e6-b497-4cff-80d8-279404a60283 61 fields · synced Jul 9, 2026