Identity
- Trade Name
- Instrumentation Difra FDA UDI
- Generic Name
- Posturography system platform FDA UDI
- Device Name
- VIDEOSTAR II is a binocular freefield videonystagmoscope device. It transcribes the image of both eyes on the computer screen. It helps to asses the reaction of the patient viewing his eyes and its nystagmus during testing. The device consists of a goggle equipped with two cameras and an infrared mirror that enables to record both eye's movement without denying patient's field of view a removable cover to set the patient in total darkness and software running on a computer. FDA UDI
- Model / Reference
- VIDEOSTAR II FDA UDI
- Description
- VIDEOSTAR II is a binocular freefield videonystagmoscope device. It transcribes the image of both eyes on the computer screen. It helps to asses the reaction of the patient viewing his eyes and its nystagmus during testing. The device consists of a goggle equipped with two cameras and an infrared mirror that enables to record both eye's movement without denying patient's field of view a removable cover to set the patient in total darkness and software running on a computer. FDA UDI
Identifiers
- Catalog Number
- 22092 FDA UDI
- Primary DI / UDI-DI
- B516220920 FDA UDI
- FDA Product Code
- GWN FDA UDI
- GMDN Term
- Posturography system platform 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Posturography system platform
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 be8e1389-6f3c-47a6-9e34-781859d4bb2f 35 fields · synced May 30, 2026