Clarius Ultrasound Scanner

FDA UDI

Class II (US FDA UDI)

by Clarius Mobile Health Corp

Identity

Trade Name: Clarius Ultrasound Scanner FDA UDI
Generic Name: Noninvasive device battery charger FDA UDI
Device Name: The Clarius 2-in-1 Charging Station HD is a charging station that combines a dock for charging HD Scanners, that has a separate port for charging a spare HD battery. FDA UDI
Model / Reference: Clarius 2-in-1 Charging Station HD FDA UDI
Description: The Clarius 2-in-1 Charging Station HD is a charging station that combines a dock for charging HD Scanners, that has a separate port for charging a spare HD battery. FDA UDI

Identifiers

Catalog Number: 99-03-00022, 99-13-00016 FDA UDI
Primary DI / UDI-DI: 07540205001028 FDA UDI
FDA Product Code: IYN FDA UDI
IYO FDA UDI
ITX FDA UDI
GMDN Term: Noninvasive device battery charger FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1550 FDA UDI
892.1560 FDA UDI
892.1570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Noninvasive device battery charger

Clarius Ultrasound Scanner by Clarius Mobile Health Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Clarius Mobile Health Corp

Sources (1)

FDA UDI 623e7e91-3923-4093-a5a8-118851cb1d55 34 fields · synced Jun 8, 2026