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105 device results listed.

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06974760129674

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: 06974760129674
Basic UDI-DI: B-06974760129674
Reference: R1: 2×60 mL, R2: 2×15 mL
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
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

06974671101998

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101998
Basic UDI-DI: B-06974671101998
Reference: DR-CLIA-CK-A045
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
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

CK-MB Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)

XJ010

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473305013
Basic UDI-DI: B-06974473305013
Reference: XJ010
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
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

CK-MB Rapid Test Kit (Colloidal gold method)

XJ003

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473300605
Basic UDI-DI: B-06974473300605
Reference: XJ003
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
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

Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)

Quality Control: 2mL×1（92104）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868217
Basic UDI-DI: B-06971674868217
Reference: Quality Control: 2mL×1（92104）
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)

R1:48mL×2 R2:12mL×2（716）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863731
Basic UDI-DI: B-06971674863731
Reference: R1:48mL×2 R2:12mL×2（716）
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)

R1:48mL×2 R2:12mL×2（715）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863724
Basic UDI-DI: B-06971674863724
Reference: R1:48mL×2 R2:12mL×2（715）
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)

R1:48mL×2 R2:12mL×2（713）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863717
Basic UDI-DI: B-06971674863717
Reference: R1:48mL×2 R2:12mL×2（713）
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)

R1:100mL×1 R2:25mL×1（708）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863700
Basic UDI-DI: B-06971674863700
Reference: R1:100mL×1 R2:25mL×1（708）
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)

R1:80mL×2 R2:20mL×2（706）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863694
Basic UDI-DI: B-06971674863694
Reference: R1:80mL×2 R2:20mL×2（706）
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)

R1:48mL×2 R2:12mL×2（705）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863687
Basic UDI-DI: B-06971674863687
Reference: R1:48mL×2 R2:12mL×2（705）
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)

R1:40mL×4 R2:20mL×2（704）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863670
Basic UDI-DI: B-06971674863670
Reference: R1:40mL×4 R2:20mL×2（704）
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)

R1:20mL×1 R2:5mL×1（702）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863663
Basic UDI-DI: B-06971674863663
Reference: R1:20mL×1 R2:5mL×1（702）
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)

R1:20mL×4 R2:5mL×4（709）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863656
Basic UDI-DI: B-06971674863656
Reference: R1:20mL×4 R2:5mL×4（709）
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)

R1:64mL×2 R2:16mL×2（701）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863649
Basic UDI-DI: B-06971674863649
Reference: R1:64mL×2 R2:16mL×2（701）
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-02B0027YV

Cardiac troponin I/Myoglobin/Creatine Kinase MB Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0027YV
Basic UDI-DI: B-02B0027YV
Reference: 3B001
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:29

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Test Kit (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807173090Q8
Basic UDI-DI: B-000012807173090Q8
Reference: HWTS-OT104
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465237955
Basic UDI-DI: 697846523enzymeC02U6
Reference: 100 tests
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465237948
Basic UDI-DI: 697846523enzymeC02U6
Reference: 50 tests
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465237931
Basic UDI-DI: 697846523enzymeC02U6
Reference: 25 tests
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details