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Fluosoft

by Fluoptics SAS

Ref FS-CL

Fluosoft (FS-CL) is a Class IIa device made by Fluoptics SAS, registered in EUDAMED on 16 Jun 2023 (Basic UDI-DI ++B475FS800W4), withdrawn as of 23 Oct 2026.

Withdrawn Withdrawn in European Union.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Was authorized under CE MDR, withdrawn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Withdrawn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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B475FS800W4 Basic UDI-DI +B475FS-CL0UDI-DIDate16 Jun 2023RegisteredStatusWithdrawn 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  • Withdrawn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European Union — CE/MDR Withdrawn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

Model / reference
FS-CL
Primary DI / UDI-DI
+B475FS-CL0
Basic UDI-DI
++B475FS800W4
EMDN code
Z119082 Various bioimaging and radiotherapy instruments - software accessories
Device class
Class IIa
Special device type
Software
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000403

Similar devices in this category

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

Other devices from Fluoptics SAS

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Properties

Other properties (14, all answered No)