10,000 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdr
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MicroScan LabPro V5.0 System DVD Kit (FMR)
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Inc.·Not intended for eu market
MicroScan LabPro Connect V5.0 System DVD Kit (FMR)
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Inc.·Not intended for eu market
MicroScan LabPro V4_V5 Maintenance Update 05 (MR,FMR), Electronic
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Inc.·On the market·15 countries
BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
Device
EU IVDR
·
Eu Ivd Class A
·Precision for Medicine, Inc.·On the market·6 countries
CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device
EU IVDR
·
Eu Ivd Class A
·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·On the market
CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device
EU IVDR
·
Eu Ivd Class A
·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·On the market
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