Profile
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Basic Information
- Primary DI
- 00855730007290
- Basic UDI-DI Code
- B-00855730007290
- Reference
- D310
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Diagnosys LLC
Additional Description
The Profile system is an electro-diagnostic device used to generate photic signals and to display the images of waveforms from the electrical signals generated by the retina and the visual nervous system. It displays digitized images of waveforms for electroretinogram (ERG), visual evoked potential (VEP), and sensory electro-oculogram (EOG) signals, as well as sweep visual evoked potentials, electrically evoked response (EER), pupillometry testing in response to photic flashes, and psychophysical tests such as scotopic threshold sensitivity testing (FST) and dark adaptometry testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1212012001 | VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 41313861 | INTERTEK SEMKO AB |
Available In Countries
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