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Sleepiz One+

by Sleepiz AG Switzerland EUDAMED

Ref 09

EMDN Z12030282

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7649996477NGCS012U Basic UDI-DIDate1 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
09
Primary DI / UDI-DI
07649996477095
Basic UDI-DI
7649996477NGCS012U
Direct Marketing DI
07649996477095
EMDN Code
Z12030282 Vital signs monitoring instruments - software accessories
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000011783
Authorised representative
MED-RAS GmbH Regulatory Affairs Service DE-AR-000006211

Other devices from Sleepiz AG

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 32fe90e9-1b13-459c-b4df-d0a9ef0d43f1 61 fields · synced 22 Oct 2026