Skip to content

Omega

by Sanita Consumer Products 3 variants

Ref UP070104

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 Number6222022108623NG Basic UDI-DI 6222022108623UDI-DIDate18 Aug 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  • Withdrawn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
UP Omega XLRG 90x180 30 x4
Model / Reference
UP070104
Primary DI / UDI-DI
6222022108623
Basic UDI-DI
6222022108623NG
EMDN Code
T04010201 Untuckable underpads
Device Class
Class I
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
EG-MF-000057771
Authorised representative
EUROMED Authorized Services Kft HU-AR-000051628

Other devices from Sanita Consumer Products

See all devices from Sanita Consumer Products →

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