32 results
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42ms
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Sources: EU EUDAMED, US FDA
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