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FLUOBEAM LS system

by Fluoptics SAS 3 variants

Ref CS_FBLS_PC

FLUOBEAM LS system (CS_FBLS_PC) is a Class IIa device made by Fluoptics SAS, registered in EUDAMED on 21 Oct 2024 (Basic UDI-DI ++B475CSFBLSXQ), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B475CSFBLSXQ Basic UDI-DI +B475CSFBLSPC0UDI-DIDate21 Oct 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
FLUOBEAM LS system
Model / reference
CS_FBLS_PC
Primary DI / UDI-DI
+B475CSFBLSPC0
Basic UDI-DI
++B475CSFBLSXQ
EMDN code
Z119080 Various bioimaging and radiotherapy instruments - hardware accessories
Device class
Class IIa
System or procedure pack
System
EU registration type
System or procedure pack
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

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

Other properties (2, all answered No)