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Ensodata, Inc.

United StatesFDA applicant, unverified FDA FEI 3013724298

Ensodata, Inc. is a medical device manufacturer, with 10 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 14 Nov 2026.

Devices
10
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 7
  • FDA 510(k) 3

A device listed in two registries counts in both.

Device classes
  • FDA Class II 9
  • FDA Class I 1
Identifiers
  • FDA FEI 3013724298
  • DUNS 080743964

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI

What Ensodata, Inc. makes

Ensodata, Inc. develops professional-use software for interpreting sleep disorder data and monitoring vulnerable patients in home settings. Products include tools like EnsoSleep for sleep analysis, Celeste+ for patient monitoring, and EnsoTherapy for therapeutic applications, alongside EnsoSleep PPG for photoplethysmography-based sleep tracking. The Aurora system is also part of their portfolio for sleep disorder assessment.

The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II. They are listed under 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. The manufacturer operates from the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue10

Newest first, rows 1-10 of 10

  • EnsoSleep PPG 7.0

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Celeste+ 8

    Active Regimes: 510(k) Registry: GUDID Class:II

  • EnsoSleep 01.1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • EnsoSleep 7.0

    Active Regimes: 510(k) Registry: GUDID Class:II

  • EnsoSleep 8

    Active Regimes: 510(k) Registry: GUDID Class:II

  • EnsoTherapy 6.0

    Withdrawn Registry: GUDID Class:I

  • EnsoSleep PPG 8

    Active Regimes: 510(k) Registry: GUDID Class:II

  • EnsoSleep Ref K162627

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Aurora Ref K231355

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • EnsoSleep Ref K210034

    Active Regimes: 510(k) Registry: 510(k) Class:II

Company details

FDA FEI number
3013724298
DUNS number
080743964
Address
10 E Doty St. Suite 449, Madison, WI, 53703
Phone
6085094704

Frequently asked questions

How many devices does Ensodata, Inc. have in the registry?

The registry currently lists 10 devices for Ensodata, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ensodata, Inc.'s devices?

Among its 10 most recently registered devices, Ensodata, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Ensodata, Inc.'s devices fall under?

Among its 10 most recently registered devices, the classes recorded for Ensodata, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Ensodata, Inc. in the registry?

The most recently registered devices listed for Ensodata, Inc. include EnsoSleep PPG 7.0, Celeste+ 8, EnsoSleep 01.1 and EnsoSleep 7.0.

Generated automatically from registry data and not verified by a human reviewer.