ACMASME002

Organization name

CENTERVUE S.P.A.

SRN

IT-MF-000017082

Manufacturer status

Active

Primary placement in Italy; available across 32 countries total.

Trade name

not provided

UDI-DI code

08053677040055

Basic UDI-DI

B-08053677040055

Reference / catalog number

ACMASME002

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

S-MAIA is a confocal, line scanning, infrared, ophthalmoscope, combined with a system for visible light projection to obtain perimetric measurements, integrating in one device an automated perimeter and an ophthalmoscope. S-MAIA provides measurements of threshold sensitivity, fixation site and fixation stability as well as confocal images of the retina. S-MAIA allows to measure retinal sensitivity both in mesopic and scotopic background light conditions. S-MAIA contains a normative database for the quantitative comparison of macular sensitivity to the corresponding normal values (mesopic test only).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z1212012003PERIPHERAL VISION ANALYSERS