Is this your brand? Sign in to claim ownership.

Somnomedics GmbH

Last updated May 24, 2026

What Somnomedics GmbH makes

Somnomedics GmbH manufactures polysomnography and sleep monitoring devices, including polysomnographs, polygraphs, and wearable physiological recorders for clinical and home-use sleep apnoea assessment. Their portfolio includes polysomnography analysers, ambulatory blood pressure monitors, and modular patient monitoring systems with features like EEG, ECG, and photic stimulation. Devices also cover accessories such as foot straps, pneumotachographs, and wireless PLM (periodic limb movement) measurement sets.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. Somnomedics GmbH is based in the US, with its products authorised for commercial distribution through these regulatory pathways.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (54)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
SOMNOtouch RESP Add-on device	TOR100AU	FDA UDI	N/A	Active
Set for wireless PLM measurement	NGA113	FDA UDI	Class II	Active
Photic Stimulator Set	EXT008	FDA UDI	N/A	Active
Foot Strap	SOW005	FDA UDI	Class II	Active
SOMNOscreen HD EEG 32 Set 2	NGD741U	FDA UDI	N/A	Active
SOMNOscreen HD PSG with Camera COMPACT	NGDV202AU	FDA UDI	N/A	Active
SOMNOscreen plus PSG+ BT AASM Set	SBT201AU	EUDAMEDFDA UDI	N/A	Active
Pneumotachograph Set	NGS273	FDA UDI	N/A	Active
SOMNOwatch plus ACTI	SOWP200Z	FDA UDI	Class II	Active
Simplified Sleep Stage Evaluation	SEP617	FDA UDI	N/A	Active
1 channel ECG sensor including body position and disposable electrodes	NGS091S	FDA UDI	Class II	Active
SOMNOscreen plus RC easy Set	SSP500U	FDA UDI	N/A	Active
SOMNOscreen plus PSG+ Tele Camera Compact AASM Set	SBTV202AU	EUDAMEDFDA UDI	N/A	Active
PLM Sensor Set (Activity)	SOW115	FDA UDI	N/A	Active
1-channel EEG option for SOMNOtouch RESP	TOS041	FDA UDI	Class II	Active
SOMNOscreen plus PSG+ AASM Set	SSP201AU	EUDAMEDFDA UDI	N/A	Active
SOMNOscreen ECO EEG 32	NGN740U	FDA UDI	Class II	Active
SOMNOscreen plus Accessory	SEN209	FDA UDI	Class II	Active
Watch Strap - Size L	SOW003	FDA UDI	Class II	Active
SOMNOscreen	SSC050	FDA UDI	Class II	Active
SOMNOscreen HD EEG32 with Camera	NGDV741U	FDA UDI	N/A	Active
SOMNOscreen plus Accessory	SEN215	FDA UDI	Class II	Active
SOMNOscreen plus EEG32 Tele Set	SBT719PU	EUDAMEDFDA UDI	N/A	Active
SLP Thermistor LOW COST	SEN600S	FDA UDI	Class II	Active
SOMNOwatch plus ACTI	SOWP200	FDA UDI	Class II	Active
SOMNOscreen plus EEG32 Tele Camera	SBTV719PU	EUDAMEDFDA UDI	N/A	Active
ABPM pro basic device	ABP050U	FDA UDI	Class II	Active
SOMNOtouch RESP accessory	TOS011S	FDA UDI	Class II	Active
SOMNOscreen eco	NGN050U	FDA UDI	Class II	Active
SOMNOtouch RESP Respiratory Screening Set	TOR100U	FDA UDI	N/A	Active
SOMNOtouch RESP accessory	TOS110S	FDA UDI	Class II	Active
SOMNOscreen HD PSG	NGD201AU	FDA UDI	N/A	Active
1-channel ECG Electrode	SEN627	FDA UDI	Class II	Active
SOMNOwatch plus ACTI + PLM (Activity)	SOWP311	EUDAMEDFDA UDI	N/A	Active
SOMNOscreen HD EEG32	NGD740U	FDA UDI	N/A	Active
Miniaturized Pneumotachograph Set	SEN513	FDA UDI	N/A	Active
AASM Headbox	TOS095U	FDA UDI	N/A	Active
SOMNOtouch RESP Accessory	TOS095	FDA UDI	Class II	Active
PLM Sensor Set	SOW116	FDA UDI	N/A	Active
SOMNOtouch RESP	TOR050U	FDA UDI	Class II	Active
SOMNOwatch plus ACTI	SOWP100Z	EUDAMEDFDA UDI	Class II	Active
Simplified Sleep Stage Evaluation for SOMNOtouch RESP	TOS051	FDA UDI	N/A	Active
SOMNOwatch plus ACTI + PLM	SOWP310	EUDAMEDFDA UDI	N/A	Active
SOMNO HD / ECO accessory	NGA310	FDA UDI	Class II	Active
Digital PSG Head Box for SOMNO HD	NGS901	FDA UDI	Class II	Active
SOMNOtouch RESP accessory	TOS175S	FDA UDI	Class II	Active
SOMNOscreen HD EEG 32 Set	NGA300U	FDA UDI	N/A	Active
SOMNOscreen plus Cardio RESP Screener Set	SSP100U	EUDAMEDFDA UDI	N/A	Active
SOMNOscreen HD PSG Tele	NGD202AU	FDA UDI	N/A	Active
Somnowatch	K081485	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.