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SleepQ

by WELT Corp. South Korea EUDAMED

Ref WELT-IP-DEModel WELT-IP

EMDN Z129092

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880954820SLEEPQTN Basic UDI-DIDate26 Aug 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

Device Name
Insomnia DTx
Model / Reference
WELT-IP, WELT-IP-DE
Primary DI / UDI-DI
08809548200086
Basic UDI-DI
880954820SLEEPQTN
EMDN Code
Z129092 Various instruments for functional exploration and therapeutic interventions - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000040293
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from WELT Corp.

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 40fe18c8-7ee6-4d67-9eee-98483c7e1ba8 61 fields · synced 22 Oct 2026