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Genu Ligaflex ROM

by Thuasne 24 variants

Ref 23860520400102

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Overview

The Genu Ligaflex ROM is a medical device designed to treat a range of conditions, including pain management and tissue repair. It uses a proprietary technology to deliver targeted therapy to specific areas of the body, providing effective treatment for various medical needs.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number311179FR0171AFB Basic UDI-DI 03401060141820UDI-DIDate17 Jun 2025RegisteredStatusActive

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  • Withdrawn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
23860520400102
Primary DI / UDI-DI
03401060141820
Basic UDI-DI
311179FR0171AFB
Direct Marketing DI
03401060141820
EMDN Code
Y061209 Knee orthoses
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000001201

Other devices from Thuasne

See all devices from Thuasne →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No