471 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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Kai Industries Co., Ltd.
Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·6 Devices·4 Importers·TÜV Rheinland LGA Products GmbH
TOSOH AIA, INC.
FDA registration
TOSOH AIA, INC.·58 products·🇯🇵 Japan
DIA PHARMACEUTICAL CO., LTD
FDA registration
DIA PHARMACEUTICAL CO., LTD·1 product·🇯🇵 Japan
DERMAL CURETTE 2 mm
Device
EU MDR
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Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE 7 mm
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE 5 mm
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE 4 mm
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE 3 mm
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·6 devices
HZ 2066395-1
Certificate
MDR QMS·Kai Industries Co., Ltd.·TÜV Rheinland LGA Products GmbH
B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
AIA-PACK FOLATE
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Tosoh Corporation·1 device
AIA-PACK B12
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Tosoh Corporation·1 device
AIA-PACK TgAb
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Tosoh Corporation·1 device
AIA-PACK TPOAb
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Tosoh Corporation·1 device
ST AIA-PACK Presepsin
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Tosoh Corporation·1 device