ENSODATA, INC.

5 devices* 9 registrations
✕ UK (MHRA) ✕ EU (EUDAMED)
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Devices

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Device Name US UK CA AU EU
Aurora Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
CELESTE+ Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
ENSOHST Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
EnsoSleep Registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
ENSOSLEEP PPG Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)

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