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SOMNOmedics AG

Germany·DE-MF-000006921

Last updated September 17, 2026

Information

Country: Germany
Address: 63, Am Sonnenstuhl , Randersacker, Germany
Website: somnomedics.de
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: —
EUDAMED SRN: DE-MF-000006921
FDA FEI Number: 3006258337
DUNS Number: 314112173

Catalogue (376)

Page 3 of 8

Device	Model / Reference	Registries	Class	Status
HomeSleepTest REM+ (HST REM+) + Tablet + OtwoFellow (size S, L & XL)	HSTR110	EUDAMED	Class IIa	Active
HomeSleepTest (HST) + Tablet + Data Contract	HST102	EUDAMED	Class IIa	Active
Somno Hd Rc	NGD100A	EUDAMED	Class IIa	Active
SOMNO HD eco PSG pediatric	NGN202Ap	EUDAMED	Class IIa	Active
Sleep Adagio PSG PRO	SAD252	EUDAMED	Class IIa	Active
SOMNO HD eco PSG Tele	NGN202A	EUDAMED	Class IIa	Active
Add-on device: SOMNOtouch RESP (PLM + ECG)	TOR140A	EUDAMED	Class IIa	Active
SOMNO HD eco RC pediatric	NGN100Ap	EUDAMED	Class IIa	Active
SOMNOtouch NIBP (pediatric)	TON105	EUDAMED	Class IIa	Active
ABPMpro Cardio	ABP110O	EUDAMED	Class IIa	Active
HomeSleepTest REM+ (HST REM+) + Tablet	HSTR101	EUDAMED	Class IIa	Active
Inductive Effort Belts	SAS664/1	EUDAMED	Class IIa	Active
Sleep Adagio PSG combi electrode & PLM	SAD200	EUDAMED	Class IIa	Active
SOMNO HD eco PSG	NGN201A	EUDAMED	Class IIa	Active
HomeSleepTest audio with data contract	HSTA102	EUDAMED	Class IIa	Active
OtwoFellow size L incl. cloud account	CIR123	EUDAMED	Class IIa	Active
SOMNO HD PSG eco with PTZ Camera	NGNV202A	EUDAMED	Class IIa	Active
SOMNO HD PSG eco with PTZ Camera pediatric	NGNV202Ap	EUDAMED	Class IIa	Active
SOMNOtouch™ RESP eco with NONIN module	TOR050-E-N	EUDAMED	Class IIa	Active
OtwoFellow size XL incl. smartphone and app	CIR114	EUDAMED	Class IIa	Active
HomeSleepTest REM+ (HST REM+) + Tablet + OtwoFellow (size S)	HSTR111	EUDAMED	Class IIa	Active
Extension cable for sensors - PLM input	SEN073	EUDAMED	Class I	Active
SOMNOtouch RESP eco	TOR100-E-D	EUDAMED	Class IIa	Active
NARCOguide, Basic-Version	DOA100-RTB-1	EUDAMED	Class IIb	Active
SOMNOscreen plus PSG+Tele (BT) AASM	SBT202A	EUDAMED	Class IIa	Active
HomeSleepTest (HST) + Tablet + OtwoFellow (size L)	HST113	EUDAMED	Class IIa	Active
SOMNOtouch NIBP	TON120	EUDAMED	Class IIa	Active
XL PLM sensor right for SOMNO HD	NGS077	EUDAMED	Class IIa	Active
SpO2 Wrap Finger Clip	SEWP151	EUDAMEDFDA UDI	Class IIa	Active
Cuff ABPMpro for right arm	ABP501R	EUDAMED	Class I	Active
Dual pressure sensor for Pneumotachograph	NGS272	EUDAMED	Class IIa	Active
Inductive Effort Belts - Size XXL	SEN663	EUDAMEDFDA UDI	Class IIa	Active
1-channel EEG sensor	TOS040	EUDAMED	Class IIa	Active
ECG-Sensor	SEW130	EUDAMED	Class IIa	Active
SOMNOtouch™ RESP eco	TOR050-E	EUDAMED	Class IIa	Active
Adapter for thermistor	NGS150	EUDAMEDFDA UDI	Class I	Active
Effort-sensor exchange article	TOS175-A	EUDAMED	Class IIa	Active
Thermistor	NGS151	EUDAMEDFDA UDI	Class IIa	Active
Pleth sensor for ABPMpro	ABP510	EUDAMED	Class IIa	Active
Dockingstation for SOMNO HD	NGA102	EUDAMED	Class I	Active
Nasal/Oral Flow Sensor Thermistor	SEN599T	EUDAMEDFDA UDI	Class IIa	Active
SOMNOtouch™ RESP eco anniversary edition	TOR050-E-D	EUDAMED	Class IIa	Active
Nasal/Oral flow sensor thermistor adult for Sleep Adagio	SAS100	EUDAMED	Class IIa	Active
Sleep Adagio® PSG	SAX050	EUDAMED	Class IIa	Active
OtwoFellow (Size L)	CIR003	EUDAMED	Class IIa	Active
Adapter for Microphone with high Sampling Rate	SEN606A	EUDAMED	Class I	Active
Multiple docking station for three devices	NGA103	EUDAMED	Class I	Active
6-channel EEG-Sensor	SEWP142	EUDAMED	Class IIa	Active
Right-angled adapter	SEN213	EUDAMED	Class I	Active
Pressure Sensor	SEN638	EUDAMED	Class IIa	Active

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Somnomedics GmbH US