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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

CK-MB Assay Kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001089
Basic UDI-DI: B-06974521001089
Reference: SUPM040072
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Assay Kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001072
Basic UDI-DI: B-06974521001072
Reference: SUPM040036
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for NT-proBNP (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: 06974521000686
Basic UDI-DI: B-06974521000686
Reference: SUPF014025
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
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

Diagnostic Kit for Myoglobin (Myo) (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: 06974521000679
Basic UDI-DI: B-06974521000679
Reference: SUPF009025
EMDN: W01021304
EMDN description: MYOGLOBIN
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

Diagnostic Kit for CK-MB (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: 06974521000525
Basic UDI-DI: B-06974521000525
Reference: SUPF019025
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
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

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

Diagnostic Kit for BNP (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: 06974521000495
Basic UDI-DI: B-06974521000495
Reference: SUPF027025
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
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

Myo Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)

XJ011

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473308991
Basic UDI-DI: B-06974473308991
Reference: XJ011
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:12

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

BNP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)

XJ009

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473304955
Basic UDI-DI: B-06974473304955
Reference: XJ009
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
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

NT-proBNP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)

XJ012

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473302746
Basic UDI-DI: B-06974473302746
Reference: XJ012
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

H-FABP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)

XJ013

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473302531
Basic UDI-DI: B-06974473302531
Reference: W01021302
EMDN: W01021302
EMDN description: HEART-TYPE FATTY ACID BINDING PROTEIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

hs cTnI /CK-MB/MyoRapid Test Kit (Quantum Dot Fluorescence Immunoassay)

XJ008

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473300575
Basic UDI-DI: B-06974473300575
Reference: XJ008
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: 06974464591487
Basic UDI-DI: B-06974464591487
Reference: 5184C4X025
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Rapid Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: 06974464591470
Basic UDI-DI: B-06974464591470
Reference: 5194C4X025
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details