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Flexsoft

by Orthosoft 2 variants

Ref FL12D, FL12G, FL11GModel FLEXSOFT

Flexsoft (FL12D) is a Class I device made by Orthosoft, registered in EUDAMED on 13 Apr 2022 (Basic UDI-DI 37602703434010449376H), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37602703434010449376H Basic UDI-DI Date13 Apr 2022RegisteredStatusActive

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  • Withdrawn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
FLEXSOFT, FL12D, FL12G, FL11G
Primary DI / UDI-DI
03760270340264, 03760270340240, 03760270340257
Basic UDI-DI
37602703434010449376H
EMDN code
Y060612 Wrist-hand orthoses
Device class
Class I
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000216

Similar devices in this category

Other devices filed under WRIST-HAND ORTHOSES.

Other devices from Orthosoft

See all devices from Orthosoft →

Properties

Other properties (14, all answered No)