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Visiolite®Flex

by FIM Medical

Ref FF1165

Visiolite®Flex (FF1165) is a Class I device made by Fim Medical, registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI 376025345FF1165TW), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376025345FF1165TW Basic UDI-DI 03760253450683UDI-DIDate21 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  • Withdrawn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

Device name
Visiolite®Flex
Model / reference
FF1165
Primary DI / UDI-DI
03760253450683
Basic UDI-DI
376025345FF1165TW
EMDN code
Z1212012001 Visual functional assessment equipment
Device class
Class I
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000017090

Similar devices in this category

Other devices filed under VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT.

Other devices from Fim Medical

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Properties

Other properties (14, all answered No)