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FLUOBEAM LM system

by Fluoptics SAS France EUDAMED

Ref CS_FBLM_PC

EMDN Z119080

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B475CSFBLMXC Basic UDI-DIDate2 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
FLUOBEAM LM system
Model / Reference
CS_FBLM_PC
Primary DI / UDI-DI
+B475CSFBLMPCS/CL0
Basic UDI-DI
++B475CSFBLMXC
EMDN Code
Z119080 Various bioimaging and radiotherapy instruments - hardware accessories
Device Class
Class IIa
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.

Manufacturer details

EUDAMED SRN
FR-PR-000002882

Other devices from Fluoptics SAS

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Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 094b8093-9ae3-4280-abdb-e750e01d245f 61 fields · synced 23 Oct 2026