51 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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EIKEN CHEMICAL CO., LTD.
Manufacturer
🇯🇵 Japan·11 Basic UDI-DIs·38 Devices·14 Importers
Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666
FDA Enforcement
Class II
·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023
Loopamp™ Malaria Pv Detection Kit
Device
EU IVDR
·
Eu Ivd Class C
·EIKEN CHEMICAL CO., LTD.·On the market·1 country
Loopamp™ Malaria Pf Detection Kit
Device
EU IVDR
·
Eu Ivd Class C
·EIKEN CHEMICAL CO., LTD.·On the market·1 country
Loopamp™ Malaria Pan Detection Kit
Device
EU IVDR
·
Eu Ivd Class C
·EIKEN CHEMICAL CO., LTD.·On the market·1 country
Loopamp™ Malaria Pan Detection Kit
Device
EU IVDR
·
Eu Ivd Class C
·EIKEN CHEMICAL CO., LTD.·On the market·1 country
OC-SENSOR FIT Latex Reagent (for OC-SENSOR DIANA, PLEDIA)
Device
EU IVDR
·
Eu Ivd Class C
·EIKEN CHEMICAL CO., LTD.·On the market·5 countries
OC-SENSOR FIT Latex Reagent (for OC-SENSOR Micro)
Device
EU IVDR
·
Eu Ivd Class C
·EIKEN CHEMICAL CO., LTD.·On the market·1 country
OC-Light™ S FIT Sampling Bottles
Device
EU IVDR
·
Eu Ivd Class A
·EIKEN CHEMICAL CO., LTD.·On the market·1 country
OC-FCa Calibrator
Device
EU IVDR
·
Eu Ivd Class B
·EIKEN CHEMICAL CO., LTD.·On the market·2 countries
OC-FIT Calibrator for OC-SENSOR Ceres
Device
EU IVDR
·
Eu Ivd Class C
·EIKEN CHEMICAL CO., LTD.·On the market·2 countries
Loopamp™ MTBC Detection Kit
Device
EU IVDR
·
Eu Ivd Class C
·EIKEN CHEMICAL CO., LTD.·On the market·1 country
OC-FCa Control LV3
Device
EU IVDR
·
Eu Ivd Class B
·EIKEN CHEMICAL CO., LTD.·On the market·2 countries
OC-FCa Control LV2
Device
EU IVDR
·
Eu Ivd Class B
·EIKEN CHEMICAL CO., LTD.·On the market·2 countries
OC-FCa Control LV1
Device
EU IVDR
·
Eu Ivd Class B
·EIKEN CHEMICAL CO., LTD.·On the market·2 countries
OC-FCa Reagent (OC-SENSOR Ceres)
Device
EU IVDR
·
Eu Ivd Class B
·EIKEN CHEMICAL CO., LTD.·On the market·2 countries
OC-FCa Reagent (OC-SENSOR PLEDIA)
Device
EU IVDR
·
Eu Ivd Class B
·EIKEN CHEMICAL CO., LTD.·On the market·2 countries
OC-SENSOR Sample Diluent (For OC-SENSOR Ceres)
Device
EU IVDR
·
Eu Ivd Class C
·EIKEN CHEMICAL CO., LTD.·On the market·2 countries
OC-FIT Control LV2
Device
EU IVDR
·
Eu Ivd Class C
·EIKEN CHEMICAL CO., LTD.·On the market·5 countries
OC-SENSOR Sample Diluent
Device
EU IVDR
·
Eu Ivd Class C
·EIKEN CHEMICAL CO., LTD.·On the market·3 countries