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Omnitex

by Sharon Services (UK) Ltd. 20 variants

Ref OX-BIB100-ADModel Disposable Bibs / clothing protectors

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506064521BIB01US Basic UDI-DI 05060645212614UDI-DIDate24 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  • Withdrawn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
Disposable Bibs / clothing protectors
Model / Reference
Disposable Bibs / clothing protectors, OX-BIB100-AD
Primary DI / UDI-DI
05060645212614
Basic UDI-DI
506064521BIB01US
Direct Marketing DI
05060645212614
EMDN Code
T99 Protective devices and aids for incontinence (excluding personal protective equipment - PPE) - other
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