Skip to content

SOMNOwatch plus ACTI + Respiratory Screening

by SOMNOmedics AG Germany EUDAMED

Ref SOWP320Model SOMNOwatch plus EMDN Z1203020202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42504134SOMNOwatchplusAK Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
SOMNOwatch plus, SOWP320
Primary DI / UDI-DI
04250413406111
Basic UDI-DI
42504134SOMNOwatchplusAK
EMDN Code
Z1203020202 Transportable/portable multi–parameter patient monitors
Device Class
Class IIa
Medical Purpose
The SOMNOwatch™ plus is a portable, miniaturized multi-channel measuring system for recording physiological signals on an outpatient basis. The SOMNOwatch™ plus helps the doctor to diagnose sleep disorders.

Manufacturer details

EUDAMED SRN
DE-PR-000042026

Other devices from SOMNOmedics AG

See all devices from SOMNOmedics AG →

Properties & raw data

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

Sources (1)

  • EUDAMED 04250413406111|42504134SOMNOWATCHPLUSAK 61 fields · synced 25 Oct 2026