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61 device results listed.

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Myocardial Infarction (MI) 3-in-1 (cTnI/CK-MB/MYO) Test Kit (Immunofluorescence)

25 Tests /Box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893001483
Basic UDI-DI: B-06921893001483
Reference: 22401910500020
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Bulgaria
Authorised representative: Sungo Cert GmbH
Last updated: 12.08.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemic Modified Albumin Reagent Kit (ACB Assay)

R1: 1x30mL, R2: 1x10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239175
Basic UDI-DI: B-06942202239175
Reference: 3013028
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemic Modified Albumin Reagent Kit (ACB Assay)

R1: 1x30mL, R2: 1x10mL, Calibration sample: 2x1mL, Control: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239656
Basic UDI-DI: B-06942202239656
Reference: 3012933
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemic Modified Albumin Reagent Kit (ACB Assay)

R1: 1x30ml, R2: 1x10ml, Calibration sample: 2x1mL, Control: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239151
Basic UDI-DI: B-06942202239151
Reference: 3011606
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemic Modified Albumin Reagent Kit (ACB Assay)

R1: 1x30ml, R2: 1x10ml

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239168
Basic UDI-DI: B-06942202239168
Reference: 3011744
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792638
Basic UDI-DI: B-06954414792638
Reference: IF1005、IF2005、 IF3005、IF4005、 IF5005、 IF6005、 IF8005
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemic Modified Albumin Reagent Kit (ACB Assay)

R1: 1x30mL, R2: 1x10mL, Control: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202260766
Basic UDI-DI: B-06942202260766
Reference: 3011892
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:27

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck D-Dimer Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214358
Basic UDI-DI: B-06933260214358
Reference: BT2105-D-Dimer
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

sST2 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802604434
Basic UDI-DI: B-06926802604434
Reference: MCL03702E
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

sST2 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802604427
Basic UDI-DI: B-06926802604427
Reference: MCL03701E
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemic Modified Albumin Reagent Kit (ACB Assay)

R1: 1x30mL, R2: 1x10mL， Calibration sample: 2x1mL, Control: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593115
Basic UDI-DI: B-06925794593115
Reference: 3021564
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:48

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemic Modified Albumin Reagent Kit (ACB Assay)

R1: 1x30mL, R2: 1x10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593108
Basic UDI-DI: B-06925794593108
Reference: 3021669
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:48

Manufacturer products Authorised representative products Authorised representative actors View details

ox-LDL/MDA Addukt ELISA

ox-LDL/MDA Adduct ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598178106
Basic UDI-DI: B-04050598178106
Reference: K 7810
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

06954418517374

25 Tests /kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai Medconn Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000038615
UDI-DI: 06954418517374
Basic UDI-DI: B-06954418517374
Reference: NA
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 16.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Reagent kit

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai Medconn Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000038615
UDI-DI: 06954418517381
Basic UDI-DI: B-06954418517381
Reference: /
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 16.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS NT-proBNP/ST2

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042830
Basic UDI-DI: 880613300626CK
Reference: SMFP-85
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ NT-proBNP/ST2

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042793
Basic UDI-DI: 880613300029BT
Reference: CFPC-163
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-364A

Multiple (9 Items) Cardiac Marker Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-364A
Basic UDI-DI: B-TD-HNKX-CED-364A
Reference: /
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-2749

DISKFLU Multiple Cardiac Marker Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-2749
Basic UDI-DI: B-TD-HNKX-CED-2749
Reference: /
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-233Z

LYOFIA Multiple Cardiac Marker Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-233Z
Basic UDI-DI: B-TD-HNKX-CED-233Z
Reference: /
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details