Ema Sleep Incorporated
Country not established
- Devices
- 45
What Ema Sleep Incorporated makes
Ema Sleep Incorporated manufactures the EMA 3D, a device designed for three-dimensional imaging and analysis of sleep-related structures, likely used in respiratory or positional sleep disorder assessments.
The company’s portfolio is regulated under FDA Class II devices, with the EMA 3D authorised via the 510(k) pathway. The device is listed in the FDA’s 510(k) clearance registry, and the manufacturer is based in the United States.
Catalogue
Search and filter all 45 devicesCompany details
- DUNS number
- 100648767
- [email protected]
- Phone
- 5125857861
Frequently asked questions
How many devices does Ema Sleep Incorporated have in the registry?
The registry currently lists 45 devices for Ema Sleep Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ema Sleep Incorporated's devices?
Among its 45 most recently registered devices, Ema Sleep Incorporated has devices listed in FDA 510(k) (1 device) and FDA GUDID (44 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ema Sleep Incorporated's devices fall under?
Among its 45 most recently registered devices, the classes recorded for Ema Sleep Incorporated's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ema Sleep Incorporated in the registry?
The most recently registered devices listed for Ema Sleep Incorporated include EMA NOW PATIENT STARTER KITS, EMA Serena Patient Starter kits, EMA 3D PATIENT STARTER KITS and INDIVIDUAL EMA STRAPS(EMAST13W) EMA 13 WHITE.