Sapphire II (RX) Coronary Dilatation Catheter

Basic UDI-DI

EU MDD · Eu Md Class 3 ·OrbusNeich Medical (Shenzhen) Co.,Ltd·1 device

Sapphire II PRO Coronary Dilatation Catheter

Basic UDI-DI

EU MDD · Eu Md Class 3 ·OrbusNeich Medical (Shenzhen) Co.,Ltd·1 device

Sapphire II (RX) Coronary Dilatation Catheter

Basic UDI-DI

EU MDD · Eu Md Class 3 ·OrbusNeich Medical (Shenzhen) Co.,Ltd·1 device

Sapphire II PRO Coronary Dilatation Catheter

Basic UDI-DI

EU MDD · Eu Md Class 3 ·OrbusNeich Medical (Shenzhen) Co.,Ltd·1 device

Sapphire II (RX) Coronary Dilatation Catheter

Basic UDI-DI

EU MDD · Eu Md Class 3 ·OrbusNeich Medical (Shenzhen) Co.,Ltd·1 device

1434-MDD-149/2021

Certificate

MDD Annex II Section 4·RFBio Co., Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs

Reflex Medical OÜ

Authorized representative

🇪🇪 Estonia

Veritas Eston OÜ

Authorized representative

🇪🇪 Estonia

Tattoo Armour OÜ

Authorized representative

🇪🇪 Estonia

JOUMED TECHNOLOGY OÜ

Authorized representative

🇪🇪 Estonia·1 Manufacturer

SMIS International OÜ

Authorized representative

🇪🇪 Estonia

Stretton Europe OÜ

Authorized representative

🇪🇪 Estonia·1 Manufacturer·50 Devices

Scanvic Chem OÜ

Authorized representative

🇪🇪 Estonia·2 Manufacturers

NATPAT EU OÜ

Authorized representative

🇪🇪 Estonia·1 Manufacturer

Viceroy Group OÜ

Authorized representative

🇪🇪 Estonia

Businext Eesti OÜ

Authorized representative

🇪🇪 Estonia

IVD GROUP Sp. z o. o.

System producer

🇵🇱 Poland

Crossmed Sp. z o. o. Sp. Komandytowa

Importer

🇵🇱 Poland

KWADRON Sp. z o. o. Sp. k.

Importer

🇵🇱 Poland

Triangle Surgical Europe OÜ

Authorized representative

🇪🇪 Estonia