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SOMNOtouch RESP Respiratory Screening

by SOMNOmedics AG Germany EUDAMED

Ref TOR100Model SOMNOtouch RESP

EMDN Z12100501

Regulatory status

as of 24 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, TOR100
Primary DI / UDI-DI
04250413404001
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 d1b331d4-c464-47f9-a44c-4bdb9337516c 61 fields · synced 24 Oct 2026