Identity
- Trade Name
- Instrumentation Difra FDA UDI
- Generic Name
- Posturography system platform FDA UDI
- Device Name
- The videonystagmoscope transcribes the image of the patient's eye on a computer screen. The VIDEOSTAR can thus assess the reactions of the patient viewing his nystagmus during testing positions, caloric, rotary or due to any other stimulus. The camera can be placed in front of the patient's right or left eye. The camera is fixed on a mask, fitting the line of the patient's face in order to occult completely from the outside light. The second eye view is either closed by an eyepiece or let free, which leaves it a free view. TECHNICAL SPECIFICATION: USB 2.0 connection 30 frames/s Resolution: 640 x 480 pixels Cable of 5 meters Compatible Windows Seven/8 - 32 or 64 bits FDA UDI
- Model / Reference
- VIDEOSTAR FDA UDI
- Description
- The videonystagmoscope transcribes the image of the patient's eye on a computer screen. The VIDEOSTAR can thus assess the reactions of the patient viewing his nystagmus during testing positions, caloric, rotary or due to any other stimulus. The camera can be placed in front of the patient's right or left eye. The camera is fixed on a mask, fitting the line of the patient's face in order to occult completely from the outside light. The second eye view is either closed by an eyepiece or let free, which leaves it a free view. TECHNICAL SPECIFICATION: USB 2.0 connection 30 frames/s Resolution: 640 x 480 pixels Cable of 5 meters Compatible Windows Seven/8 - 32 or 64 bits FDA UDI
Identifiers
- Catalog Number
- 22090 FDA UDI
- Primary DI / UDI-DI
- B51622090 FDA UDI
- FDA Product Code
- HJJ FDA UDI
- GMDN Term
- Posturography system platform FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1390 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 I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Difra SA
Sources (1)
- FDA UDI b5b5522f-9ca8-4c3c-bb9a-2d2e870d310f 35 fields · synced May 30, 2026