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01.08.2026 18:27

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146 device results listed.

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06975090500423

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Accucise Diagnostics Inc.
Manufacturer SRN: CN-MF-000045017
UDI-DI: 06975090500423
Basic UDI-DI: B-06975090500423
Reference: 1040401000
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay CK-MB (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070762490
Basic UDI-DI: B-06975070762490
Reference: 18307101
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Ireland
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit(Chemiluminescent Immunoassay)

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986813685
Basic UDI-DI: B-06974986813685
Reference: 200 Tests/Kit
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit(Chemiluminescent Immunoassay)

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986813678
Basic UDI-DI: B-06974986813678
Reference: 100 Tests/Kit
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit(Chemiluminescent Immunoassay)

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986813661
Basic UDI-DI: B-06974986813661
Reference: 50 Tests/Kit
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme Assay Kit (Immunochromatographic Assay)

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986812299
Basic UDI-DI: B-06974986812299
Reference: 100 tests/kit
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme Assay Kit (Immunochromatographic Assay)

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986812282
Basic UDI-DI: B-06974986812282
Reference: 50 tests/kit
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme Assay Kit (Immunochromatographic Assay)

10 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986812275
Basic UDI-DI: B-06974986812275
Reference: 10 tests/kit
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme Assay Kit (Immunochromatographic Assay)

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986811971
Basic UDI-DI: B-06974986811971
Reference: 25 tests/kit
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzymes （CK-MB）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

200 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982315
Basic UDI-DI: B-06974969982315
Reference: 200 Tests/kit（DR1077-3）
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzymes （CK-MB）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: 06974969981745
Basic UDI-DI: B-06974969981745
Reference: 100 Tests/kit（DR1077-2）
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
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

Creatine Kinase Isoenzymes （CK-MB）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: 06974969981172
Basic UDI-DI: B-06974969981172
Reference: 50 Tests/kit（DR1077-1）
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
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

Creatine kinase-MB 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: 06974738205065
Basic UDI-DI: B-06974738205065
Reference: IF11-01-40
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine kinase-MB 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: 06974738205058
Basic UDI-DI: B-06974738205058
Reference: IF11-01-20
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme (CK-MB) 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: 06974674892671
Basic UDI-DI: B-06974674892671
Reference: 18-02-0139
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
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

Creatine Kinase Isoenzyme (CK-MB) Detection Kit(Fluorescence Immunoassay)

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674891711
Basic UDI-DI: B-06974674891711
Reference: 18-02-0118
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:12

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine kinase-MB (CK-MB)Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524061585
Basic UDI-DI: B-06974524061585
Reference: HCLIA15125
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
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

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 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