gudid Primary ID: HeadStar V3.0

Instrumentation Difra SA (UDI HeadStar V3.0)

Manufactured by Instrumentation Difra SA

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Instrumentation Difra SA (Model/Catalog Number: HeadStar V3.0) is a medical device manufactured by Instrumentation Difra SA. This product is indexed under FDA Product Code / Category Classification GWN within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: HeadStar V3.0
Product Code / EMDN: GWN
Device Name: The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. HEADSTAR is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus), the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests and the Video Head Impulse Test. HEADSTAR is a nystagmography system and is able to record movements of one eye: horizontal, vertical and rotary on option. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. HEADSTAR is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run VHIT tests and other oculomotor tests.
Database Sync Date: 2026-08-09 09:34:46

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Instrumentation Difra SA?

The registered manufacturer of record for Instrumentation Difra SA is Instrumentation Difra SA.

What is the Primary UDI-DI identifier for Instrumentation Difra SA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is HeadStar V3.0.

What classification code is assigned to this device?

This device is registered under product classification code GWN.

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