BIJOU

Primary DI

08809822314614

Basic UDI-DI Code

B-08809822314614

Reference

MP29050070H

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

21 Century Medical Co., Ltd.

Sterile single use polydioxanone(PDO) Suture with needle consists of needle, needle cap, hub, sponge and polydioxanone(PDO) suture and is sterilized by EO gas. The safety and effectiveness of polydioxanone(PDO) is acceptable because Polydioxanone(PDO) to be used to this device is absorb suture that has already used to sew the wound at normal hospital since 2001 and needle also has been used in hospital. Raw materials to use to this device have been used to many medical device as syringe and disposable medical devices.

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).