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FLUOBEAM 800 system

by Fluoptics SAS 3 variants

Ref CS_FB800_IS

FLUOBEAM 800 system (CS_FB800_IS) is a Class IIa device made by Fluoptics SAS, registered in EUDAMED on 2 May 2024 (Basic UDI-DI ++B475CSFB800NK), withdrawn as of 24 Oct 2026.

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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++B475CSFB800NK Basic UDI-DI +B475CSFB800IS/CL0UDI-DIDate2 May 2024RegisteredStatusWithdrawn No longer placed on the EU market

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device name
FLUOBEAM 800 system
Model / reference
CS_FB800_IS
Primary DI / UDI-DI
+B475CSFB800IS/CL0
Basic UDI-DI
++B475CSFB800NK
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 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.

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)