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Sleep Breath Monitoring Software

by Asleep Inc EUDAMED

Active European Union

Ref Apnotrack

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880993333ApnoTrackEUP5 Basic UDI-DIDate5 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Sleep Breath Monitoring Software
Model / Reference
Apnotrack
Primary DI / UDI-DI
08809933330015
Basic UDI-DI
880993333ApnoTrackEUP5
EMDN Code
Z12080406 Apnoea monitors
Device Class
Class I
Special Device Type
Software
Market of Registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000054415
Authorised representative
SOAR & PARTNERS Sp. z o.o. PL-AR-000040956

Properties

Show 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