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T3s Recorder EU

by Nox Medical Iceland EUDAMED

Ref 561011Model ASDB1SEU

EMDN Z12100501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-15694311111436 Basic UDI-DIDate29 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
ASDB1SEU, 561011
Primary DI / UDI-DI
15694311111436
Basic UDI-DI
B-15694311111436
EMDN Code
Z12100501 Polysomnographs
Device Class
Class IIa
Market of Registration
Iceland

Manufacturer details

EUDAMED SRN
IS-MF-000000950

Other devices from Nox Medical

See all devices from Nox Medical →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 17adbfde-4bcd-4fb2-a5b0-82e1b8591908 61 fields · synced 23 Oct 2026