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HomeSleepTest (REM+) audio + OtwoFellow (Size S, L & XL)

by SOMNOmedics AG

Ref HSTRA110Model HomeSleepTest

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42504134HomeSleepTestYC Basic UDI-DI 04250413406692UDI-DIDate10 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
HomeSleepTest, HSTRA110
Primary DI / UDI-DI
04250413406692
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

Other properties (1)

  • Sterile: No