60 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdr
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CAPILLARYS 3 DBS
Device
EU IVDR
·
Eu Ivd Class A
·sebia·On the market
CAPILLARYS 3 DBS MICROPLATES
Device
EU IVDR
·
Eu Ivd Class A
·sebia·On the market
BT 1500 C/CBS
Device
EU IVDR
·
Eu Ivd Class A
·Biotecnica Instruments S.r.l.·On the market·32 countries
DBS CoreShell-Dried Blood Spot Kit
Device
EU IVDR
·
Eu Ivd Class A
·Sinopharm Allmed (Hubei) Medical Products Co., Ltd.·On the market
Fenom Pro
Device
EU IVDR
·
Eu Ivd Class A
·CAIRE Diagnostics Inc.·On the market
ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS)
Device
EU IVDR
·
Eu Ivd Class C
·RECIPE Chemicals + Instruments GmbH·On the market·32 countries
ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS), non-derivatised
Device
EU IVDR
·
Eu Ivd Class C
·RECIPE Chemicals + Instruments GmbH·On the market·32 countries
ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS) with Filter-Plates
Device
EU IVDR
·
Eu Ivd Class C
·RECIPE Chemicals + Instruments GmbH·On the market·32 countries
Creatine kinase MB(CLIA)、CK-MB Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS) with Filter-Plates, non-derivatised
Device
EU IVDR
·
Eu Ivd Class C
·RECIPE Chemicals + Instruments GmbH·On the market·32 countries
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