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SOMNOtouch wireless (ECG)

by SOMNOmedics AG

Ref WPG125Model SOMNOtouch wireless

SOMNOtouch wireless (ECG) (WPG125) is a Class IIa device made by SOMNOmedics AG, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 42504134SOTwirelessBG), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42504134SOTwirelessBG Basic UDI-DI 04250413407439UDI-DIDate5 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
SOMNOtouch wireless, WPG125
Primary DI / UDI-DI
04250413407439
Basic UDI-DI
42504134SOTwirelessBG
EMDN code
Z12100501 Polysomnographs
Device class
Class IIa
System or procedure pack
System
EU registration type
System or procedure pack
Medical purpose
The SOMNOtouch™ wireless 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

Other properties (2, all answered No)