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DormiApnea

by Sleepacta Srl

Ref 111914608371-1.0.0

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberPP13374SLEEP78 Basic UDI-DI PP 13374 SLEEP 78 APNEA1.0.0UDI-DIDate12 Jul 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
111914608371-1.0.0
Primary DI / UDI-DI
PP 13374 SLEEP 78 APNEA1.0.0
Basic UDI-DI
PP13374SLEEP78
Direct Marketing DI
PP 13374 SLEEP 78 APNEA1.0.0
EMDN Code
Z12030292 Vital signs monitoring instruments - medical device software
Device Class
Class I
Special Device Type
Software
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000041068

Other devices from Sleepacta Srl

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