DIGITAL LABORATORY MICROSCOPES

Primary DI

04262402090010

Basic UDI-DI Code

426240209iO:M8AQ

Reference

PP00050742

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

PreciPoint GmbH

The iO:M8 digital light microscope system is intended for the in vitro diagnostic use to provide digital images of surgical pathology slides prepared from frozen tissue and cytology preparations that can be used to aid the pathologist to review and interpret physiological or pathological states. The iO:M8 consists of a digital microscope and corresponding control software “Micropoint” running on the host computer. The iO:M8 device itself is not intended to diagnose, treat, prevent, mitigate, or cure disease or medical conditions.

The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).