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Somno Hd Psg

by SOMNOmedics AG Germany EUDAMED

Ref NGD201AModel SOMNO HD

EMDN Z12100501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42504134SOMNOHDND 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
SOMNO HD, NGD201A
Primary DI / UDI-DI
04250413410163
Basic UDI-DI
42504134SOMNOHDND
EMDN Code
Z12100501 Polysomnographs
Device Class
Class IIa
Medical Purpose
The SOMNO HD is a portable device for continuous recording of physiological signals. It can serve the physician as a polysomnography (PSG) system to assist in the diagnosis of sleep disorders, as well as a long-term EEG device.

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 27408f98-125a-4e92-8770-c99e173ec6e9 61 fields · synced 24 Oct 2026