FLUOBEAM LX system

EUDAMED

Class IIa (EU MDR)

Ref CS_FBLX_DURef CS_FBLX_ARef CS_FBLXRef CS_FBLX_PCRef CS_FBLX_IS

Identity

Device Name: FLUOBEAM LX system EUDAMED
Model / Reference: CS_FBLX_DU EUDAMED
CS_FBLX_A EUDAMED
CS_FBLX EUDAMED
CS_FBLX_PC EUDAMED
CS_FBLX_IS EUDAMED

Primary DI / UDI-DI: +B475CSFBLXDU/CL0 EUDAMED
+B475CSFBLXA/CL0 EUDAMED
+B475CSFBLXS/CL0 EUDAMED
+B475CSFBLXPCS/CL0 EUDAMED
+B475CSFBLXIS/CL0 EUDAMED
Basic UDI-DI: ++B475CSFBLXY2 EUDAMED
EMDN Code: Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED

Device Class: Class IIa EUDAMED
Medical Purpose: FLUOBEAM LX including FLUOSOFT LX is indicated to facilitate the visualization of parathyroid glands by auto-fluorescence (natural fluorescence without ICG injection) during thyroid and parathyroid surgeries. FLUOBEAM LX including FLUOSOFT LX 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. EUDAMED

Sterile

EUDAMED

FLUOBEAM LX system by Fluoptics Sas — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	++B475CSFBLXY2	Class IIa	Active

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