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    <deviceName>Creatine Kinase Assay Kit (DGKC Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
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    <legislation>IVDD</legislation>
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    <reference>DTSH040106</reference>
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    <lastUpdated>2026-07-06T19:12:26.421Z</lastUpdated>
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    <deviceName>Creatine Kinase Assay Kit (DGKC Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
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    <lastUpdated>2026-07-06T19:12:24.821Z</lastUpdated>
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    <deviceName>Creatine Kinase (CK) Assay Kit (Phosphocreatine Substrate Method)</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
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    <tradeName>06973262865837</tradeName>
    <deviceName>Creatine Kinase (CK) Kit (Rate Method)</deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T13:56:18.392Z</lastUpdated>
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    <basicUdiDi>B-06971674863632</basicUdiDi>
    <tradeName>Creatine Kinase (CK)Test Kit(IFCC)</tradeName>
    <deviceName>Creatine Kinase (CK)Test Kit(IFCC)</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 - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:12mL×2（716）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:19:55.880Z</lastUpdated>
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    <tradeName>Creatine Kinase (CK)Test Kit(IFCC)</tradeName>
    <deviceName>Creatine Kinase (CK)Test Kit(IFCC)</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 - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:19:54.436Z</lastUpdated>
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    <tradeName>Creatine Kinase (CK)Test Kit(IFCC)</tradeName>
    <deviceName>Creatine Kinase (CK)Test Kit(IFCC)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:12mL×2（715）</reference>
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    <lastUpdated>2026-07-06T10:19:49.233Z</lastUpdated>
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    <tradeName>Creatine Kinase (CK)Test Kit(IFCC)</tradeName>
    <deviceName>Creatine Kinase (CK)Test Kit(IFCC)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:5mL×4（796）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:19:38.951Z</lastUpdated>
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    <tradeName>Creatine Kinase (CK)Test Kit(IFCC)</tradeName>
    <deviceName>Creatine Kinase (CK)Test Kit(IFCC)</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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:24mL×1（792）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:19:34.412Z</lastUpdated>
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    <tradeName>Creatine Kinase (CK)Test Kit(IFCC)</tradeName>
    <deviceName>Creatine Kinase (CK)Test Kit(IFCC)</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 - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:19:31.636Z</lastUpdated>
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    <tradeName>Creatine Kinase (CK)Test Kit(IFCC)</tradeName>
    <deviceName>Creatine Kinase (CK)Test Kit(IFCC)</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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:100mL×1  R2:25mL×1（708）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:19:30.903Z</lastUpdated>
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    <tradeName>Creatine Kinase (CK)Test Kit(IFCC)</tradeName>
    <deviceName>Creatine Kinase (CK)Test Kit(IFCC)</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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:12mL×2（705）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:19:28.221Z</lastUpdated>
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    <basicUdiDi>B-06971674863557</basicUdiDi>
    <tradeName>Creatine Kinase (CK)Test Kit(IFCC)</tradeName>
    <deviceName>Creatine Kinase (CK)Test Kit(IFCC)</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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:40mL×4  R2:20mL×2（704）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:19:26.260Z</lastUpdated>
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    <tradeName>Creatine Kinase (CK)Test Kit(IFCC)</tradeName>
    <deviceName>Creatine Kinase (CK)Test Kit(IFCC)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
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    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×1  R2:5mL×1（702）</reference>
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    <lastUpdated>2026-07-06T10:19:26.227Z</lastUpdated>
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    <tradeName>Creatine Kinase (CK)Test Kit(IFCC)</tradeName>
    <deviceName>Creatine Kinase (CK)Test Kit(IFCC)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
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    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:5mL×4（709）</reference>
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    <lastUpdated>2026-07-06T10:19:25.257Z</lastUpdated>
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    <tradeName>Creatine Kinase (CK)Test Kit(IFCC)</tradeName>
    <deviceName>Creatine Kinase (CK)Test Kit(IFCC)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
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    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:64mL×2  R2:16mL×2（701）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:19:21.439Z</lastUpdated>
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    <tradeName>CK (IFCC)</tradeName>
    <deviceName>CK (IFCC)</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981828</reference>
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    <lastUpdated>2026-07-02T06:07:16.147Z</lastUpdated>
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    <deviceName>CK BM 100 / BM 200</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
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    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
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    <lastUpdated>2026-07-02T02:23:59.196Z</lastUpdated>
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    <manufacturerName>Medicon Hellas SA</manufacturerName>
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    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
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    <reference>1418-0097</reference>
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    <lastUpdated>2026-07-01T23:52:46.761Z</lastUpdated>
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    <tradeName>CK</tradeName>
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    <manufacturerName>Instrumentation Laboratory SpA</manufacturerName>
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    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0018164640</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:25:39.651Z</lastUpdated>
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