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somnio

by mementor DE GmbH

Ref somnio

Active European Union

CE MDR

Valid until

19 Dec 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Berlin Cert GmbH

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 NumberPP12257SOMNIO57 Basic UDI-DI 1312257SOMNIO-V1067UDI-DIDate13 Jan 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • Z-22-103-S-IX Active

    Quality management system EU MDR

    Certifier
    Berlin Cert GmbH 0633
    Issued
    20 Dec 2024
    Expires
    19 Dec 2029

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
somnio
Primary DI / UDI-DI
1312257SOMNIO-V1067
Basic UDI-DI
PP12257SOMNIO57
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000007354

Other devices from mementor DE GmbH

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