EASYPREP®

Primary DI

08806125619019

Basic UDI-DI Code

88061256EZP36

Reference

EZP

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

YD Diagnostics CORP.

EASYPREP® is a device that smears cervical cells or non-gynecological cells preserved in a preservative solution onto a slide. Slides produced using EASYPREP® are intended for cell reading, and the device itself does not contain any qualitative or quantitative detection and/or measurement capabilities. Additionally, as it is an automated device, it comes with a built-in program that allows the entire system operation process to be automatically controlled through the touch screen. Different smear methods can be set up for various specimen types. There is no the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate in EASYPREP®.

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