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SOMNOtouch RESP (PLM)

by SOMNOmedics AG Germany EUDAMED

Ref TOR120Model SOMNOtouch RESP

EMDN Z12100501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42504134SOMNOtouchRESPZS Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
SOMNOtouch RESP, TOR120
Primary DI / UDI-DI
04250413405312
Basic UDI-DI
42504134SOMNOtouchRESPZS
EMDN Code
Z12100501 Polysomnographs
Device Class
Class IIa
Medical Purpose
The SOMNOtouch™ RESP is a portable device for recording physiological signals, which serves the physician as a Polygraphy (PG) or Polysomnography (PSG) system to assist in the diagnosis of sleep disorders.

Manufacturer details

EUDAMED SRN
DE-PR-000042026

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Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 67fefd76-bb09-4063-8c7c-1675076785cd 61 fields · synced 24 Oct 2026