PERIPHERAL VISION ANALYSERS
Basic Information
- Primary DI
- 08053677040024
- Basic UDI-DI Code
- B-08053677040024
- Reference
- ATMARME002
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- CENTERVUE S.P.A.
Additional Description
MAIA is a confocal, line scanning, infrared, ophthalmoscope, combined with a system for visible light projection to obtain perimetric measurements, hence integrating in one device an automated perimeter and an ophthalmoscope. MAIA provides measurements of threshold sensitivity, fixation site and fixation stability as well as confocal images of the retina. MAIA contains a normative database for the quantitative comparison of macular sensitivity to the corresponding normal values. MAIA is intended for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1212012003 | PERIPHERAL VISION ANALYSERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 070221 0013 | TรV SรD Product Service GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).