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CLARIUS MOBILE HEALTH CORP.

Canada·CA-MF-000037016

Last updated September 17, 2026

Information

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Clarius Ultrasound System	K172385	FDA 510(k)	Class II	Active
Clarius Ultrasound Scanner	K213436	FDA 510(k)	Class II	Active
Clarius Ultrasound System	K163138	FDA 510(k)	Class II	Active
Clarius Prostate AI	K243853	FDA 510(k)	Class II	Active
Clarius Bladder AI	K232257	FDA 510(k)	Class II	Active
Clarius Ultrasound Scanner	K180799	FDA 510(k)	Class II	Active
Clarius 2-in-1 Charging Station	99-13-00016	EUDAMED	Class I	Active
Clarius Scanner C7 HD3	99-13-00019	EUDAMEDFDA UDI	Class IIa	Active
Clarius App - iOS	12-01-00003	EUDAMEDFDA UDI	Class IIa	Active
Clarius Battery HD	99-13-00010	EUDAMED	Class I	Active
Clarius Scanner PA HD	99-13-00007	EUDAMED	Class IIa	Active
Clarius Scanner C3 HD3	99-13-00018	EUDAMEDFDA UDI	Class IIa	Active
Clarius App - Android	12-01-00004	EUDAMEDFDA UDI	Class IIa	Active
Clarius Charger HD3	99-13-00030	EUDAMEDFDA UDI	Class I	Active
Clarius Scanner PAL HD3	99-13-00029	EUDAMEDFDA UDI	Class IIa	Active
Clarius Scanner L20 HD3	99-13-00022	EUDAMEDFDA UDI	Class IIa	Active
Clarius Scanner L20 HD	99-13-00014	EUDAMED	Class IIa	Active
Clarius Scanner C3 HD	99-13-00002	EUDAMED	Class IIa	Active
Clarius Scanner C7 HD	99-13-00003	EUDAMED	Class IIa	Active
Clarius Power Fan HD3	99-03-00024	EUDAMEDFDA UDI	Class I	Active
Clarius Charger HD	99-13-00008	EUDAMED	Class I	Active
Clarius Scanner EC7 HD3	99-13-00024	EUDAMEDFDA UDI	Class IIa	Active
Clarius Scanner L15 HD	99-13-00005	EUDAMED	Class IIa	Active
Clarius Scanner PA HD3	99-13-00023	EUDAMEDFDA UDI	Class IIa	Active
Clarius Scanner L15 HD3	99-13-00021	EUDAMEDFDA UDI	Class IIa	Active

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