32 results · 42ms · Sources: EU EUDAMED, US FDA

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FCU Co., Ltd.

Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

FCU CO., LTD.

FDA registration
FCU CO., LTD.·3 products·🇰🇷 South Korea

Sonovation1L, SOFRA1L, SonoInfra1L, Dr.SAFE, ACUFRIEND, ACUGUIDE,ACUWARY, AcuViz Pocket, Sono Cloud 1, eZono1000, eZ1L

Device
EU MDD · Eu Md Class 2a ·FCU Co., Ltd.·On the market·1 country

SC1 Handheld ultrasound imaging system

Basic UDI-DI
EU MDD · Eu Md Class 2a ·FCU Co., Ltd.·1 device

eZono AG

Authorized representative
🇩🇪 Germany·1 Manufacturer·1 Device

1434-MDD-365/2021

Certificate
MDD Annex II (excluding section 4)·FCU Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

eZono AG

Importer
🇩🇪 Germany·2 Manufacturers

Handan FCH Medical Technology Co.,Ltd.

Manufacturer
🇨🇳 China·2 Basic UDI-DIs·7 Devices

Stool Management Bag

Device
EU MDR · Eu Md Class 1 ·Handan FCH Medical Technology Co.,Ltd.·On the market

Suction Liners

Device
EU MDR · Eu Md Class 1 ·Handan FCH Medical Technology Co.,Ltd.·On the market

Suction Liners

Device
EU MDR · Eu Md Class 1 ·Handan FCH Medical Technology Co.,Ltd.·On the market

Suction Liners

Device
EU MDR · Eu Md Class 1 ·Handan FCH Medical Technology Co.,Ltd.·On the market

Suction Liners

Device
EU MDR · Eu Md Class 1 ·Handan FCH Medical Technology Co.,Ltd.·On the market

Suction Liners

Device
EU MDR · Eu Md Class 1 ·Handan FCH Medical Technology Co.,Ltd.·On the market

Suction Liners

Device
EU MDR · Eu Md Class 1 ·Handan FCH Medical Technology Co.,Ltd.·On the market

Suction Liners

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Handan FCH Medical Technology Co.,Ltd.·6 devices

Stool Management Bag

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Handan FCH Medical Technology Co.,Ltd.·1 device

TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses

FDA Recall
Open, Classified ·Chengdu Ai Qin E-commerce Co., Ltd N0.200, Tian Fu Fifth Street Gao Xin China·Product code LPL·June 23, 2020

TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses

FDA Recall
Open, Classified ·Chengdu Ai Qin E-commerce Co., Ltd N0.200, Tian Fu Fifth Street Gao Xin China·Product code LPL·June 23, 2020

TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses

FDA Recall
Open, Classified ·Chengdu Ai Qin E-commerce Co., Ltd N0.200, Tian Fu Fifth Street Gao Xin China·Product code LPL·June 23, 2020