AIFLAME001

Organization name

CENTERVUE S.P.A.

SRN

IT-MF-000017082

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 32 countries total.

Trade name

not provided

UDI-DI code

08053677040093

Basic UDI-DI

805367704Eidon-FamilyUV

Reference / catalog number

AIFLAME001

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

EIDON FA is fundus imaging device, based on confocal scanning imaging system, which uses infrared and visible light to obtain confocal images of the retina and auto-fluorescence images. EIDON works with the embedded EIDON Software, and it operates as standalone unit. The device integrates a Custom Control Interface with multi-touch display, a 3D Joystick and an external power supply. The device acquires images of the retina, permits their visualization and post-processing.

Additional information URL

https://www.icare-world.com/IFU/

Clinical sizes

No clinical sizes registered for this device.

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

• Z12120199OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER