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HomeSleepTest (REM+) audio

by SOMNOmedics AG Germany EUDAMED

Ref HSTRA101Model HomeSleepTest

EMDN Z1203020202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42504134HomeSleepTestYC 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 25 Oct 2026

Model / Reference
HomeSleepTest, HSTRA101
Primary DI / UDI-DI
04250413406678
Basic UDI-DI
42504134HomeSleepTestYC
EMDN Code
Z1203020202 Transportable/portable multi–parameter patient monitors
Device Class
Class IIa
Medical Purpose
The HomeSleepTest is a portable, miniaturized multi-channel data acquisition and real time therapy system for recording of physiological signals and influencing sleep in the hospital or home environment. The HomeSleepTest assists the physician in the diagnosis and treatment of sleep, mental and neurological 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 04250413406678|42504134HOMESLEEPTESTYC 61 fields · synced 25 Oct 2026