OPİA

Primary DI

08683628400050

Basic UDI-DI Code

86836284OP00201N2

Reference

OP-00201-06 3XL

Device Types

Single use Sterile

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

OPİA İNOVASYON SAĞLIK MEDİKAL ARGE VE DANIŞMANLIK SAN. DIŞ TİC. A.Ş.

Additional product description: As Opia Medikal, our Disposable Standard Surgical Gowns, which we produce in our own facilities in European Standards, are prepared in accordance with European Regulations (EU-MDR) and American Health Regulations (FDA). It is made of SMS fabric with high efficiency filtering power. The Disposable Standard Surgical Gown, which is especially used in medical fields, effectively blocks liquids and particles and cuts off contact with the person. It is also covered with a special breathable coating developed by Opia R&D, resistant to static electricity, penetration, various organic solvents, acids and alkalis. Our product is convenient and comfortable for the user. It is the first company in the world to receive the MDR Certificate on this subject. Certificate Number: M.2022.MDR.1002

The Basic UDI-DI associated with this device has 6 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).