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Standard Thumb and Wrist Support- SIZE1

by Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇

Ref ARH5021-S/M/L

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number868085311ARMALLL6 Basic UDI-DI 08680853107143UDI-DIDate28 Nov 2024RegisteredStatusActive

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  • Withdrawn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
Armall
Model / Reference
ARH5021-S/M/L
Primary DI / UDI-DI
08680853107143
Basic UDI-DI
868085311ARMALLL6
Direct Marketing DI
08680853107143
EMDN Code
Y060609 Wrist (forearm) orthoses
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000030874

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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