Identity
- Trade Name
- Instrumentation Difra FDA UDI
- Generic Name
- Dynamic visual acuity testing system FDA UDI
- Device Name
- The VISIOBOX allows to stimulate visually the patient for the diagnosis of its vestibular system. With the help of your ENG/VNG system, it performs the calibration of the system and allows you to study eyes movements occurring during the following tests: random saccades, smooth pursuit and optokinetic. FDA UDI
- Model / Reference
- VisioBox II FDA UDI
- Description
- The VISIOBOX allows to stimulate visually the patient for the diagnosis of its vestibular system. With the help of your ENG/VNG system, it performs the calibration of the system and allows you to study eyes movements occurring during the following tests: random saccades, smooth pursuit and optokinetic. FDA UDI
Identifiers
- Catalog Number
- 22186 FDA UDI
- Primary DI / UDI-DI
- B51622186 FDA UDI
- FDA Product Code
- HOW FDA UDI
- GMDN Term
- Dynamic visual acuity testing system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1200 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: Dynamic visual acuity testing system
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 a5de2285-a5c5-48cf-a5e4-8059087ae8ef 35 fields · synced Jun 8, 2026