Manufacturer

SOMNOmedics

GermanyLegal entities : SOMNOmedics AG

Markets : Cyprus · Germany · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 8 · class II · latest in 2024 · see on the FDA website

Public contracts won : Cyprus 1 · Germany 1

Website

14 categories, 72 models including 72 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Multi-parameter monitors - hardware accessories	Z1203020280	1-channel ECG Electrode ECG sensor3 refs 1-channel ECG/IC-EMG sensor2 refs 1-channel EEG sensor EEG-Headbox3 refs 2-channel PLM sensor3 refs 3-port Docking station for SOMNOtouch3 refs 16 others Active EMG Sensor for Acti entrance Activity sensor3 refs Analogue Optocoupler3 refs Analogue Optocoupler (4 connections) Docking station3 refs Bruxism sensor Cable for Sleep Adagio Headbox3 refs ECG-sensor exchange article Effort sensor3 refs EDA Sensor3 refs EEG / EOG / EMG (new) Combi sensor (5 channels) with integrated light sensor EEG/EOG/EMG sensor EEG / EOG Combi sensor (3 channels) EEG/EOG sensor3 refs Effort + 1PLM Combi sensor Effort/PLM sensor2 refs Effort + 2 PLM + 1-channel ECG Combi Sensor Effort/ECG/PLM sensor2 refs Finger Sensor for NARCOguide (size L) SpO2 sensor3 refs Inductive effort sensor (RIP) Inductiv effort belt3 refs Microphone for Snoring detection Snoring detection sensor3 refs Mounting device with power supply Nasal/Oral Flow Sensor Thermistor3 refs	I, IIa MDR	EUDAMED record Report an error
Polysomnography instruments - hardware accessories	Z12100580	Abdomen/Thorax Belt - Size L3 refs Abdomen/Thorax Belt - Size L Belt set3 refs Adapter cable Sub-D-9 to MiniMed 90°3 refs Application Mount SOMNOtouch RESP Mounting belt3 refs Effort belt3 refs 6 others Inductive Effort Belt - Size L Inductiv effort belt3 refs Pneumatic Effort Belt - Size XS Pneumatic belt3 refs Shoulder belt - Size L2 refs Silicone Tube Silicon tube2 refs SOMNOwatch plus Dockingstation Docking station Y-cable 3.5mm stereo Jack cable3 refs	I, IIa MDR	EUDAMED record Report an error
Polysomnographs	Z12100501	Add-on device: SOMNOtouch NIBP3 refs Add-on device: SOMNOtouch PSG ambulatory (AASM) SOMNOtouch RESP3 refs JFD5001 SOMNOtouch3 refs JFD7001HD SOMNO HD3 refs Sleep Adagio® PG6 refs 4 others SOMNO HD EEG 323 refs SOMNOscreen plus EEG 32 BT3 refs SOMNOscreen™ plus SOMNOtouch wireless3 refs	IIa MDR	EUDAMED record Report an error
Transportable/portable multi-parameter patient monitors	Z1203020202	Add on device SOMNOwatch plus ACTI3 refs HomeSleepTest2 refs HomeSleepTest (HST) + Tablet3 refs OtwoFellow (Size L)3 refs SOMNOwatch eco Blue3 refs 1 other SOMNOwatch™ eco3 refs	IIa MDR	EUDAMED record Report an error
Pneumotachographs	Z12159008	CPAP Pressure Sensor (+/- 36 mbar) CPAP sensor3 refs Dual pressure sensor for Sleep Adagio Flow sensor3 refs Dual Pressure Sensor NGS2722 refs Miniaturized Pneumotachograph Pressure Sensor SEN6372 refs	IIa MDR	EUDAMED record Report an error
Electroencephalographs	Z12100302	32-channel EEG Headbox for SOMNO HD3 refs 6-channel EEG-Module EEG-Headbox3 refs Headbox, basic version EEG-Headbox2 refs NARCOguide, Basic-Version3 refs	IIa, IIb MDR	EUDAMED record Report an error
Multi-parameter monitors - other	Z1203020299	Bluetooth receiver for Sleep Adagio2 refs Combi Electrode including light sensor for SOMNO HD Combination sensor3 refs External ADC Board2 refs Pressur-/Flow-Sensor	I, IIa MDR	EUDAMED record Report an error
Electroencephalography instruments - hardware accessories	Z12100380	Cuff ABPMpro3 refs Cuff ABPMpro for right arm3 refs Patient interface cable, basic version2 refs	I, IIa MDR	EUDAMED record Report an error
Vital signs monitoring instruments - medical device software	Z12030292	ABPMpro Software DOMINO Software3 refs NARCOguide® T Software	I, IIa MDR	EUDAMED record Report an error
Non-invasive blood pressure monitoring instruments	Z1203020302	ABPMpro2 refs ABPMpro Advanced3 refs	IIa MDR	EUDAMED record Report an error
Body plethysmographs	Z12159007	Pleth sensor for ABPMpro3 refs	IIa MDR	EUDAMED record Report an error
Electroencephalography instruments - consumables	Z12100385	EEG-Electrode Electrodes SEN007/N2 refs	I MDR	EUDAMED record Report an error
General purpose electrocardiographs	Z12050301	SOMNOtouch™ NIBP	IIa MDR	EUDAMED record Report an error
Multi-parameter monitors - consumables	Z1203020285	EEG-Electrode Electrodes SEN0073 refs	I MDR	EUDAMED record Report an error

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