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FLUOBEAM LS system

by Fluoptics SAS France EUDAMED

Ref CS_FBLS_IS

EMDN Z119080

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B475CSFBLSXQ Basic UDI-DIDate21 Oct 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
FLUOBEAM LS system
Model / Reference
CS_FBLS_IS
Primary DI / UDI-DI
+B475CSFBLSIS0
Basic UDI-DI
++B475CSFBLSXQ
EMDN Code
Z119080 Various bioimaging and radiotherapy instruments - hardware accessories
Device Class
Class IIa
Medical Purpose
FLUOBEAM LS including FLUOSOFT LS is indicated to facilitate the visualization of parathyroid glands by auto-fluorescence (natural fluorescence without ICG injection) during thyroid and parathyroid surgeries. FLUOBEAM LS including FLUOSOFT LS 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, vessels and tissue perfusion • visualization of lymphatic system, including lymph node and vessels • visualization of malignant tissues

Manufacturer details

EUDAMED SRN
FR-PR-000002882

Other devices from Fluoptics SAS

See all devices from Fluoptics SAS →

Properties & raw data

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

Sources (1)

  • EUDAMED acd48a67-9997-490c-b517-1c4807dce0ed 61 fields · synced 24 Oct 2026