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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 5 of 8

Device	Model / Reference	Registries	Class	Status
SOMNOwatch™ eco	SOWE050	EUDAMED	Class IIa	Active
Finger Sensor for NARCOguide (size L)	DOA040	EUDAMED	Class IIa	Active
Receiver (BT)	BTR062	EUDAMED	Class I	Active
DOMINO light Software	SOW105	EUDAMED	Class IIa	Active
R&K Headbox	TOS096	EUDAMED	Class IIa	Active
Adapter cable Sub-D-9 to MiniMed 90°	SEWP152	EUDAMED	Class I	Active
Inductive Effort Belt - Size L	NGA202	EUDAMEDFDA UDI	Class IIa	Active
Active PLM Electrode (EMG) right leg	NGS071	EUDAMEDFDA UDI	Class IIa	Active
NARCOguide® T Software	DOA070	EUDAMED	Class I	Active
Flow-Sensor	SEW120	EUDAMED	Class IIa	Active
Inductive Effort Belts - Size XXXL	SEN665	EUDAMEDFDA UDI	Class IIa	Active
PSG Headbox for SOMNO HD	NGS901	EUDAMED	Class IIa	Active
Inductive Effort Belts	SAS661	EUDAMED	Class IIa	Active
Cuff ABPMpro	ABP500	EUDAMED	Class IIa	Active
Inductive Effort Belt - Size XXXL	NGA204	EUDAMEDFDA UDI	Class IIa	Active
PlethRing Sensor Small (17mm)	ABP510/S	EUDAMED	Class IIa	Active
Active Electrode	SEW110	EUDAMED	Class IIa	Active
1-channel ECG/IC-EMG sensor	TOS016	EUDAMED	Class IIa	Active
Effort sensor exchange article	TOS190-A	EUDAMED	Class IIa	Active
Pressure Sensor	SEN632	EUDAMED	Class IIa	Active
ECG-sensor exchange article	TOS175-B	EUDAMED	Class IIa	Active
AASM headbox for Sleep Adagio	SAS095	EUDAMED	Class IIa	Active
Effort + 1PLM Combi sensor	TOS140	EUDAMED	Class IIa	Active
Pneumatic Effort Belt - Size S	SEN642	EUDAMED	Class I	Active
EEG / EOG Combi sensor (3 channels) with integrated light sensor for Sleep Adagio	SAS050	EUDAMED	Class IIa	Active
Effort belt	TOS802	EUDAMEDFDA UDI	Class I	Active
Headbox, basic version	DOA010	EUDAMED	Class IIa	Active
Analogue Optocoupler, 4-channel	TOS121	EUDAMED	Class I	Active
Dual pressure sensor for Sleep Adagio	SAS175E	EUDAMED	Class IIa	Active
CPAP Pressure Sensor (0-24 mbar)	SEN635	EUDAMEDFDA UDI	Class IIa	Active
1-channel ECG sensor	NGS091	EUDAMED	Class IIa	Active
RIP-Abdomen sensor for Sleep Adagio	SAS660	EUDAMED	Class IIa	Active
NightScore Software	SAS001	EUDAMED	Class IIa	Active
AASM Headbox	TOS094	EUDAMED	Class IIa	Active
Abdomen/Thorax Belt - Size XXL	SEN236	EUDAMEDFDA UDI	Class I	Active
Active PLM Electrode (EMG) left leg	NGS070	EUDAMEDFDA UDI	Class IIa	Active
Analogue Optocoupler for CO2	SAS175D	EUDAMED	Class I	Active
Sidestream Capnometer LoFLo	NGA101	EUDAMED	Class I	Active
Soft Silicone Finger Sensor for Pulse Oximeter	SEN209	EUDAMED	Class IIa	Active
Dual Pressure Sensor	TOS200	EUDAMED	Class IIa	Active
Patient interface cable, basic version	DOA020	EUDAMED	Class IIa	Active
SOMNOwatch™ eco orange	SOWE050-O	EUDAMED	Class IIa	Active
Analogue Optocoupler	SSC082	EUDAMEDFDA UDI	Class I	Active
Flow pressure sensor for SOMNOtouch NIBP	TOS100	EUDAMED	Class IIa	Active
XL PLM sensor left for SOMNO HD	NGS076	EUDAMED	Class IIa	Active
Sensor for connection of LoFlo Capnometer to Sleep Adagio	SAS175F	EUDAMED	Class IIa	Active
ABPMpro	ABP050	EUDAMED	Class IIa	Active
Effort Sensor (RIP double)	NGS052	EUDAMED	Class IIa	Active
Inductive Effort Belts	SAS665	EUDAMED	Class IIa	Active
Effort belt	TOS801	EUDAMEDFDA UDI	Class I	Active

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FDA Establishments (1)

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Somnomedics GmbH US