Instrumentation Difra

FDA UDI

Class II (US FDA UDI)

by Instrumentation Difra SA

Identity

Trade Name: Instrumentation Difra FDA UDI
Generic Name: Electronystagmograph FDA UDI
Device Name: The Ideas III is an Electronystagmography (ENG) system. Electronystagmography measures eye movements using the method of electro-oculography (EOG). In this method, skinmounted electrodes measure changes in potentials across the eyeball due to movement of the eye in its socket. The corneal retinal potential is the source of the measured voltage. Those movements are recorded and transmitted to a computer. The eye movement is analyzed by the software.Ideas III is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests). Ideas III is able to record horizontal and vertical movements simultaneously on both eyes or on one eye only. FDA UDI
Model / Reference: Ideas III FDA UDI
Description: The Ideas III is an Electronystagmography (ENG) system. Electronystagmography measures eye movements using the method of electro-oculography (EOG). In this method, skinmounted electrodes measure changes in potentials across the eyeball due to movement of the eye in its socket. The corneal retinal potential is the source of the measured voltage. Those movements are recorded and transmitted to a computer. The eye movement is analyzed by the software.Ideas III is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests). Ideas III is able to record horizontal and vertical movements simultaneously on both eyes or on one eye only. FDA UDI

Identifiers

Catalog Number: 22315 FDA UDI
Primary DI / UDI-DI: B516223150 FDA UDI
510(k) Number: K070670 FDA UDI
FDA Product Code: GWN FDA UDI
GMDN Term: Electronystagmograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1460 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electronystagmograph

Instrumentation Difra by Instrumentation Difra SA — 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: Instrumentation Difra SA

Sources (1)

FDA UDI 67fba97f-29f2-40ef-a2db-3bbe7607a71e 35 fields · synced May 30, 2026

Instrumentation Difra

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)