60 results · 19ms · Sources: EU EUDAMED, US FDA

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Water Container (MAJ-901); Water Container (MAJ-902)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Single Use Distal Cover MAJ-2315 (MAJ-2315)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Luer-Split MAJ-2092

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

EIKEN CHEMICAL CO., LTD.

Manufacturer
🇯🇵 Japan·11 Basic UDI-DIs·38 Devices·14 Importers

AUXILIARY WATER TUBE MAJ-855

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Single-Use Biopsy Valve (MAJ-1555)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

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