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HomeSleepTest REM+ (HST REM+) + Tablet + OtwoFellow (size XL)

EUDAMED

Class IIa (EU MDR)

Ref HSTR114Model HomeSleepTest

by SOMNOmedics AG

Identity

Trade Name
HomeSleepTest REM+ (HST REM+) + Tablet + OtwoFellow (size XL) EUDAMED
Model / Reference
HomeSleepTest EUDAMED
HSTR114 EUDAMED

Identifiers

Primary DI / UDI-DI
04250413406845 EUDAMED
Basic UDI-DI
42504134HomeSleepTestYC EUDAMED
EMDN Code
Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED

Classification

Device Class
Class IIa EUDAMED
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. EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

HomeSleepTest REM+ (HST REM+) + Tablet + OtwoFellow (size XL) by SOMNOmedics AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
SOMNOmedics AG
EUDAMED SRN
DE-PR-000042026

Sources (1)

  • EUDAMED be2435a7-784b-43b6-87e4-0bb94f22ce56 61 fields · synced Jul 17, 2026