Unex

FDA UDI

Class II (US FDA UDI)

by Unex Corporation

Identity

Trade Name: UNEX FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Device Name: The UNEXEF-38G Ultrasound System is a portable,software controlled ultrasound system used to acquire and display high resolution, real time ultrasound data in a variety of modes and clinical settings. This system is Track 3 device that employs an ultrasound probe consisting of ultrasonic transducers arranged in a comb, whereby ultrasound can be generated by supplying electric pulse signals to a group of transducers consisting of multiple adjacent transducers in the single probe. FDA UDI
Model / Reference: UNEXEF-38G FDA UDI
Description: The UNEXEF-38G Ultrasound System is a portable,software controlled ultrasound system used to acquire and display high resolution, real time ultrasound data in a variety of modes and clinical settings. This system is Track 3 device that employs an ultrasound probe consisting of ultrasonic transducers arranged in a comb, whereby ultrasound can be generated by supplying electric pulse signals to a group of transducers consisting of multiple adjacent transducers in the single probe. FDA UDI

Identifiers

Primary DI / UDI-DI: 04573349040069 FDA UDI
510(k) Number: K131973 FDA UDI
FDA Product Code: ITX FDA UDI
IYO FDA UDI
IYN FDA UDI
GMDN Term: General-purpose ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1560 FDA UDI
892.1550 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

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: General-purpose ultrasound imaging system

Unex by Unex Corporation — 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: Unex Corporation

Sources (1)

FDA UDI b1df9e47-da8e-4924-8775-8df1ab5f4e6a 34 fields · synced May 30, 2026