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RheelaxX

by Yaer SARL EUDAMED

Active European Union

Ref 3770029747022, 3770029747008, 3770029747039

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3770029747RHEA4 Basic UDI-DIDate19 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
RheelaxX orthopedic insoles
Model / Reference
3770029747022, 3770029747008, 3770029747039
Primary DI / UDI-DI
03770029747022, 03770029747008, 03770029747039
Basic UDI-DI
3770029747RHEA4
EMDN Code
Y061203 Orthoses, foot (including insoles and inserts)
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000045665

Other devices from Yaer SARL

Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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