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

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08053677040048

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-08053677040048

Reference / catalog number

AMGSDME001

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

COMPASS is a scanning ophthalmoscope combined with an automatic perimeter (Fundus Perimeter), that allows the acquisition of confocal images of the retina, simultaneously to the measurement of retinal threshold sensitivity and the analysis of fixation. The device is indicated for measuring retinal sensitivity, for a quantitative assessment of fixation characteristics, as well as to capture infrared and color images of the retina without the use of a mydriatic agent.

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

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.