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Sign in to claim this brandWhat 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.
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- US
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Catalogue (54)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Somnoscreen | K060708 | FDA 510(k) | Class II | Active |
| Somnoscreen Eeg10-20 | K071556 | FDA 510(k) | Class II | Active |
| ABPMpro | K231104 | FDA 510(k) | Class II | Active |
| EEG-acp | K212325 | FDA 510(k) | Class II | Active |
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