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351 device results listed.

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Cardiac Troponin I（cTnI）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

100 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969981752
Basic UDI-DI: B-06974969981752
Reference: 100 Tests/kit（DR1078-2）
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:12

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I（cTnI）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969981189
Basic UDI-DI: B-06974969981189
Reference: 50 Tests/kit（DR1078-1）
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:10

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin-T (cTnT) Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854621190
Basic UDI-DI: B-06974854621190
Reference: P2206825
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I(cTnI) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854621060
Basic UDI-DI: B-06974854621060
Reference: P22056
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:54

Manufacturer products Authorised representative products Authorised representative actors View details

06974760129551

R1: 2×60 mL, R2: 2×15 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129551
Basic UDI-DI: B-06974760129551
Reference: R1: 2×60 mL, R2: 2×15 mL
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin-I Rapid Test Kit (Fluorescence Immunochromatographic Assay)

Please see the IFU.

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hoyotek Biomedical Co.,Ltd.
Manufacturer SRN: CN-MF-000003570
UDI-DI: 06974738205102
Basic UDI-DI: B-06974738205102
Reference: IF13-01-40
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin-I Rapid Test Kit (Fluorescence Immunochromatographic Assay)

Please see the IFU.

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hoyotek Biomedical Co.,Ltd.
Manufacturer SRN: CN-MF-000003570
UDI-DI: 06974738205096
Basic UDI-DI: B-06974738205096
Reference: IF13-01-20
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I(cTnI)Detection Kit(CLIA)

50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892640
Basic UDI-DI: B-06974674892640
Reference: 18-02-0136
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101950

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101950
Basic UDI-DI: B-06974671101950
Reference: DR-CLIA-CK-A043
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101936

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101936
Basic UDI-DI: B-06974671101936
Reference: DR-CLIA-CK-A042
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

High sensitive Cardiac Troponin T (hs-cTnT) Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524061578
Basic UDI-DI: B-06974524061578
Reference: HCLIA15123
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnT Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521004219
Basic UDI-DI: B-06974521004219
Reference: SUPM052072
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnT Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521004202
Basic UDI-DI: B-06974521004202
Reference: SUPM052036
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Assay Kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001508
Basic UDI-DI: B-06974521001508
Reference: SUPM050072
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Assay Kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001492
Basic UDI-DI: B-06974521001492
Reference: SUPM050036
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Assay Kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001423
Basic UDI-DI: B-06974521001423
Reference: SUPM038072
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Assay Kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001416
Basic UDI-DI: B-06974521001416
Reference: SUPM038036
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Cardiac Troponin T (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000518
Basic UDI-DI: B-06974521000518
Reference: SUPF026025
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

hs cTnT Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)

XJ006

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473305235
Basic UDI-DI: B-06974473305235
Reference: XJ006
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:11

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)

XJ007

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473304948
Basic UDI-DI: B-06974473304948
Reference: XJ007
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:11

Manufacturer products Authorised representative products Authorised representative actors View details