ECORAY Co., Ltd.

Manufacturer

🇰🇷 South Korea·5 Basic UDI-DIs·5 Devices·DNV Product Assurance AS

ECORAY Co., Ltd

Manufacturer

🇰🇷 South Korea·2 Basic UDI-DIs·2 Devices·DNV Product Assurance AS

EXSYS DEXi (EXSYS DEXi-A402S-FRM)

FDA registration

ECORAY CO.,LTD.·1 product·🇰🇷 South Korea

EXSYS DEXi (EXSYS DEXi-D402S-FRM)

FDA registration

ECORAY CO.,LTD.·1 product·🇰🇷 South Korea

ULTRA 1040

FDA 510(k)

FDA Class 2 ·Radiology

ULTRA 1060HF

Device

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd.·On the market·14 countries

ECOVIEW 9PLUS

Device

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd·On the market·2 countries

HF-525Plus

Device

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd·On the market·3 countries

ULTRA 200A

Device

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd.·On the market·12 countries

ULTRA 200

Device

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd.·On the market·13 countries

ULTRA 100

Device

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd.·On the market·13 countries

ULTRA 1040HF

Device

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd.·On the market·13 countries

ULTRA 200A

Basic UDI-DI

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd.·1 device

ULTRA 200

Basic UDI-DI

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd.·1 device

ULTRA 100

Basic UDI-DI

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd.·1 device

ORANGE 1040HF, ORANGE 1040, ANYPLX 5

Basic UDI-DI

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd.·1 device

ECOVIEW 9PLUS

Basic UDI-DI

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd·1 device

HF-525 Plus

Basic UDI-DI

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd·1 device

ORANGE 1060HF, ORANGE 1060, ANYPLX 7

Basic UDI-DI

EU MDD · Eu Md Class 2b ·ECORAY Co., Ltd.·1 device

12966-2018-CE-KOR-NA-PS

Certificate

MDD Annex II (excluding section 4)·ECORAY Co., Ltd·DNV Product Assurance AS·2 Basic UDI-DIs