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    <tradeName>CK-MB Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)</tradeName>
    <deviceName>CK-MB Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
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    <reference>XJ010</reference>
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    <lastUpdated>2026-07-06T16:11:13.495Z</lastUpdated>
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    <basicUdiDi>B-06974473300605</basicUdiDi>
    <tradeName>CK-MB Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>CK-MB Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
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    <tradeName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
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    <lastUpdated>2026-07-06T10:38:30.515Z</lastUpdated>
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    <basicUdiDi>B-06971674863731</basicUdiDi>
    <tradeName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:12mL×2（716）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:20:08.687Z</lastUpdated>
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    <udiDi>06971674863724</udiDi>
    <basicUdiDi>B-06971674863724</basicUdiDi>
    <tradeName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:12mL×2（715）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <basicUdiDi>B-06971674863717</basicUdiDi>
    <tradeName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:12mL×2（713）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:20:07.408Z</lastUpdated>
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    <basicUdiDi>B-06971674863700</basicUdiDi>
    <tradeName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:100mL×1  R2:25mL×1（708）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:20:07.191Z</lastUpdated>
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    <basicUdiDi>B-06971674863694</basicUdiDi>
    <tradeName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:80mL×2  R2:20mL×2（706）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:20:03.023Z</lastUpdated>
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    <basicUdiDi>B-06971674863687</basicUdiDi>
    <tradeName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:12mL×2（705）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:20:02.110Z</lastUpdated>
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    <udiDi>06971674863670</udiDi>
    <basicUdiDi>B-06971674863670</basicUdiDi>
    <tradeName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:40mL×4  R2:20mL×2（704）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:20:01.134Z</lastUpdated>
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    <basicUdiDi>B-06971674863663</basicUdiDi>
    <tradeName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×1  R2:5mL×1（702）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:20:01.129Z</lastUpdated>
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    <basicUdiDi>B-06971674863656</basicUdiDi>
    <tradeName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:5mL×4（709）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:19:55.996Z</lastUpdated>
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    <basicUdiDi>B-06971674863649</basicUdiDi>
    <tradeName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</tradeName>
    <deviceName>Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:64mL×2  R2:16mL×2（701）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:19:55.529Z</lastUpdated>
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    <udiDi>D-02B0027YV</udiDi>
    <basicUdiDi>B-02B0027YV</basicUdiDi>
    <tradeName>D-02B0027YV</tradeName>
    <deviceName>Cardiac troponin I/Myoglobin/Creatine Kinase MB Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B001</reference>
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    <lastUpdated>2026-07-05T13:29:24.654Z</lastUpdated>
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    <tradeName>CK-MB Test Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>CK-MB Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT104</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:18.035Z</lastUpdated>
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    <basicUdiDi>697846523enzymeC02U6</basicUdiDi>
    <tradeName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:28:45.108Z</lastUpdated>
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    <tradeName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:28:43.931Z</lastUpdated>
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    <tradeName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <tradeName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
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    <tradeName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-30T09:20:47.915Z</lastUpdated>
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