DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER

Primary DI

08800066500283

Basic UDI-DI Code

B-08800066500283

Reference

STERLINK

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

Plasmapp Co., Ltd

The STERLINK mini is the plasma low temperature sterilizer which is a vaporized hydrogen peroxide sterlizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. The product is operated by fully automated sterilization cycle software embedded in the system. The product sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization. The product has two modes, the pouch and chamber mode.

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