Embla Systems
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Embla Systems is a medical device manufacturer, with 40 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.
- Devices
- 40
Registry facts
- Registries
- FDA GUDID 31
- FDA 510(k) 9
- Device classes
- FDA Class II 40
What Embla Systems makes
Embla Systems manufactures polysomnography systems, including multiple physiological signal amplifiers for recording sleep-related data such as EEG, EOG, EMG, and respiratory signals. Their portfolio also includes software for interpreting sleep disorder diagnoses, designed to analyze and classify sleep patterns and abnormalities.
The company’s devices are classified as Class II under FDA regulations and are authorised via 510(k) clearances and the FDA’s Unique Device Identifier (UDI) system. These products are listed in the FDA’s regulatory databases and are intended for use in clinical and home sleep testing environments.
Catalogue
Search and filter all 40 devicesFrequently asked questions
How many devices does Embla Systems have in the registry?
The registry currently lists 40 devices for Embla Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Embla Systems's devices?
Among its 40 most recently registered devices, Embla Systems has devices listed in FDA 510(k) (9 devices) and FDA GUDID (31 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Embla Systems's devices fall under?
Among its 40 most recently registered devices, the classes recorded for Embla Systems's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Embla Systems in the registry?
The most recently registered devices listed for Embla Systems include Xltek 012001, Xltek 1421036, Xltek 2003010 and Xltek 1421023.