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Fluocart

by Fluoptics SAS

Ref FK-CL

Fluocart (FK-CL) is a Class I device made by Fluoptics SAS, registered in EUDAMED on 16 Jul 2026 (Basic UDI-DI ++B475FK9Y), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B475FK9Y Basic UDI-DI +B475FKCL0UDI-DIDate16 Jul 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
FK-CL
Primary DI / UDI-DI
+B475FKCL0
Basic UDI-DI
++B475FK9Y
Direct marketing DI
+B475FKCL0
EMDN code
Z119080 Various bioimaging and radiotherapy instruments - hardware accessories
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
FR-MF-000000403

Similar devices in this category

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

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Properties

Other properties (14, all answered No)