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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 7 of 8

Device	Model / Reference	Registries	Class	Status
Abdomen/Thorax Belt - Size L	SEN240	EUDAMEDFDA UDI	Class I	Active
Inductive Effort Belts - Size XS	SEN664	EUDAMEDFDA UDI	Class IIa	Active
Activity Sensor for Sleep/Wake detection	SEN620	EUDAMEDFDA UDI	Class IIa	Active
EEG / EOG Kombi Electrode	SEP622	EUDAMED	Class IIa	Active
Adaptor for NPT sensor	SEN561	EUDAMED	Class I	Active
OtwoFellow (Size S)	CIR001	EUDAMED	Class IIa	Active
EEG-sensor	SEW141	EUDAMED	Class IIa	Active
Combi Sensor for Sleep Adagio	SAS175A	EUDAMED	Class IIa	Active
SOMNOtouch™ NIBP	TON050	EUDAMED	Class IIa	Active
Effort + 2 PLM + 1-channel ECG Combi Sensor	TOS175L	EUDAMED	Class IIa	Active
External ECG sensor for ABPMpro	ABP520	EUDAMED	Class IIa	Active
EEG-Electrode	SEN007	EUDAMED	Class I	Active
Active EMG Sensor for Acti entrance	SEN614O	EUDAMEDFDA UDI	Class IIa	Active
32-channel EEG headbox for SOMNO HD with a longer cable	NGS902L	EUDAMED	Class IIa	Active
Body Mount SOMNOtouch RESP	TOS810	EUDAMED	Class I	Active
Soft Silicone Finger Sensor pediatric	TOS065	EUDAMEDFDA UDI	Class IIa	Active
Inductive Effort Belt - Size XXL	NGA203	EUDAMEDFDA UDI	Class IIa	Active
Interfaced Measurement Adapter	SEN657	EUDAMED	Class IIa	Active
Pressure Sensor	SEN637	EUDAMED	Class IIa	Active
2-channel PLM sensor for Sleep Adagio	SAS110	EUDAMED	Class IIa	Active
Inductive Effort Belts - Size L	SEN662	EUDAMEDFDA UDI	Class IIa	Active
EEG-Electrode	SEN007/25	EUDAMED	Class I	Active
6-channel EEG-Module	TOS090	EUDAMED	Class IIa	Active
EEG / EOG Combi sensor (3 channels)	TOS050	EUDAMED	Class IIa	Active
Pneumatic Effort Belt - Size XXL	SEN645	EUDAMED	Class I	Active
Effort belt	TOS799	EUDAMED	Class I	Active
Effort belt	TOS807	EUDAMEDFDA UDI	Class I	Active
Replacement inductive effort sensor (RIP)	TOS080-A	EUDAMED	Class IIa	Active
3-channel ECG sensor	TOS010L	EUDAMED	Class IIa	Active
Miniaturized Pneumotachograph	SEN514	EUDAMED	Class IIa	Active
Inductive Effort Belt - Size L	SEN662/1	EUDAMEDFDA UDI	Class IIa	Active
Application Mount SOMNOtouch RESP	TOS811	EUDAMED	Class I	Active
3-channel ECG sensor with body position	TOS013L	EUDAMED	Class IIa	Active
ECG sensor for Sleep Adagio	SAS175C	EUDAMED	Class IIa	Active
Shoulder belt - Size L	SEN243	EUDAMEDFDA UDI	Class I	Active
Effort Sensor	SEN640	EUDAMEDFDA UDI	Class IIa	Active
Combi sensor	SEWP170	EUDAMED	Class IIa	Active
Effort + 2PLM + 1-channel ECG Combi Sensor	TOS175	EUDAMEDFDA UDI	Class IIa	Active
Inductive Effort Belts	SAS664	EUDAMED	Class IIa	Active
SoftWrap Finger Sensor	TOS070	EUDAMED	Class IIa	Active
PlethRing Sensor X-Large (23mm)	ABP510/XL	EUDAMED	Class IIa	Active
SOMNOscreen™ plus	SSP704	EUDAMEDFDA UDI	Class IIa	Active
Application Mount with retaining clip	TOS813	EUDAMED	Class I	Active
Y-cable 3.5mm stereo	BT-K0000111	EUDAMED	Class I	Active
EDA Sensor for determination of electrodermal activity	NGS230	EUDAMED	Class IIa	Active
1-channel ECG sensor	TOS011	EUDAMEDFDA UDI	Class IIa	Active
Interfaced Measurement Adapter	SEN659A	EUDAMED	Class IIa	Active
Microphone for Snoring detection	NGS130	EUDAMEDFDA UDI	Class IIa	Active
Abdomen/Thorax Belt - Size M	SEN229	EUDAMEDFDA UDI	Class I	Active
Headbox, cardio version	DOA011	EUDAMED	Class IIa	Active

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FDA Establishments (1)

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Somnomedics GmbH US