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Omox Zip Shoulder Immo L

by Mediroyal Nordic AB

Ref MR01163000609Model MR1163

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number73400329MR11636H Basic UDI-DI 07340032912791UDI-DIDate5 May 2026RegisteredStatusActive

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  • Withdrawn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
Omox Zip Shoulder Immo
Model / Reference
MR1163, MR01163000609
Primary DI / UDI-DI
07340032912791
Basic UDI-DI
73400329MR11636H
Direct Marketing DI
07340032912791
EMDN Code
Y060621 Shoulder orthoses
Device Class
Class I
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000007821

Other devices from Mediroyal Nordic AB

See all devices from Mediroyal Nordic AB →

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