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SOMNOscreen plus RC easy (paediatric)

by SOMNOmedics AG Germany EUDAMED

Ref SSP500KModel SOMNOscreen plus EMDN Z12100501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42504134SOMNOscreenplusEQ 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  • Withdrawn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
SOMNOscreen plus, SSP500K
Primary DI / UDI-DI
04250413407156
Basic UDI-DI
42504134SOMNOscreenplusEQ
EMDN Code
Z12100501 Polysomnographs
Device Class
Class IIa
Medical Purpose
The SOMNOscreen™ plus 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.

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 04250413407156|42504134SOMNOSCREENPLUSEQ 61 fields · synced 25 Oct 2026