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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
Hand-held ultrasound imaging system, body-surface FDA UDI
Device Name
High-density transducer type – linear array (Clarius Scanner L7 HD) FDA UDI
Model / Reference
L7 HD FDA UDI
Description
High-density transducer type – linear array (Clarius Scanner L7 HD) FDA UDI

Identifiers

Catalog Number
99-02-00044, 99-13-00004 FDA UDI
Primary DI / UDI-DI
07540205001035 FDA UDI
FDA Product Code
IYN FDA UDI
IYO FDA UDI
ITX FDA UDI
GMDN Term
Hand-held ultrasound imaging system, body-surface 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hand-held ultrasound imaging system, body-surface

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

Similar devices

Also classified as Hand-held ultrasound imaging system, body-surface.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clarius Mobile Health Corp

Sources (1)

  • FDA UDI d8825ec6-2c3d-4a43-89e0-05bec4dd3b7d 34 fields · synced Jun 6, 2026