MonacoPro

Primary DI

05057056107004

Basic UDI-DI Code

50570561070088

Reference

A10700

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Optos plc

The P200TE Ophthalmoscope is an ophthalmic imaging device capable of capturing digital images of the retina and axial-sections of the retinal structures in an automated manner without mydriasis, scleral depression or contact with the cornea. It is intended to be used by clinical practitioners to assist in the diagnosis of eye disease or disorders that manifest themselves in the retina. The P200TE is based on SLO technology which scans in two dimensions over the retina. Light reflected from the retina is detected and transformed into a digital image. Images may be stored and subsequently reviewed.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).