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Omnitex

by Sharon Services (UK) Ltd. 20 variants

Ref MK-OX-50TBModel Type IIR Surgical Face Masks

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506064521SUFM018U Basic UDI-DI 05060645210528UDI-DIDate22 May 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  • Withdrawn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

Device Name
Type IIR Surgical Face Masks
Model / Reference
Type IIR Surgical Face Masks, MK-OX-50TB
Primary DI / UDI-DI
05060645210528
Basic UDI-DI
506064521SUFM018U
Direct Marketing DI
05060645210528
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
UK-MF-000047592
Authorised representative
Sharon Services Europe B.V. NL-AR-000047497

Other devices from Sharon Services (UK) Ltd.

See all devices from Sharon Services (UK) Ltd. →

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