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    <basicUdiDi>B-06971674866800</basicUdiDi>
    <tradeName>Myoglobin (MB) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName></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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:18mL×1  R2:6mL×1（702）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:32:29.697Z</lastUpdated>
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    <udiDi>06971674866794</udiDi>
    <basicUdiDi>B-06971674866794</basicUdiDi>
    <tradeName>Myoglobin (MB) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Myoglobin (MB) Test Kit (Immunoturbidimetric)</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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:18mL×4  R2:6mL×4（709）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:32:28.898Z</lastUpdated>
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    <udiDi>06971674866787</udiDi>
    <basicUdiDi>B-06971674866787</basicUdiDi>
    <tradeName>Myoglobin (MB) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Myoglobin (MB) Test Kit (Immunoturbidimetric)</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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60mL×2  R2:20mL×2（701）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:32:28.199Z</lastUpdated>
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    <udiDi>06971354101634</udiDi>
    <basicUdiDi>B-06971354101634</basicUdiDi>
    <tradeName>ReLIA</tradeName>
    <deviceName>Myoglobin Test (Colloidal Gold)</deviceName>
    <manufacturerName>ReLIA Biotechnologies (Jiangsu), Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000042042</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RG16105-20T</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:53:55.576Z</lastUpdated>
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    <udiDi>06971354101641</udiDi>
    <basicUdiDi>B-06971354101641</basicUdiDi>
    <tradeName>ReLIA</tradeName>
    <deviceName>Myoglobin Test (Colloidal Gold)</deviceName>
    <manufacturerName>ReLIA Biotechnologies (Jiangsu), Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000042042</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RG16366-50T</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:53:54.065Z</lastUpdated>
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    <udiDi>06971354100118</udiDi>
    <basicUdiDi>B-06971354100118</basicUdiDi>
    <tradeName>ReLIA</tradeName>
    <deviceName>Myoglobin Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>ReLIA Biotechnologies (Jiangsu), Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000042042</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RF16207-50T</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:51:28.061Z</lastUpdated>
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    <udiDi>06971354100101</udiDi>
    <basicUdiDi>B-06971354100101</basicUdiDi>
    <tradeName>ReLIA</tradeName>
    <deviceName>Myoglobin Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>ReLIA Biotechnologies (Jiangsu), Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000042042</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RF16053-20T</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:51:26.379Z</lastUpdated>
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    <udiDi>06971225931247</udiDi>
    <basicUdiDi>B-06971225931247</basicUdiDi>
    <tradeName>Kemilo Myo Kit</tradeName>
    <deviceName>Kemilo Myo Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM02060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:23:24.570Z</lastUpdated>
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    <udiDi>06971225931162</udiDi>
    <basicUdiDi>B-06971225931162</basicUdiDi>
    <tradeName>FIA Go Myo Kit</tradeName>
    <deviceName>FIA Go Myo Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIA09025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:23:10.863Z</lastUpdated>
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  <row>
    <udiDi>06944904032177</udiDi>
    <basicUdiDi>69449040004JMYO********Z5</basicUdiDi>
    <tradeName>Myoglobin (MYO) Kit (Particle-enhanced Immunoturbidimetric Assay Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002239-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:59.698Z</lastUpdated>
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    <udiDi>06944904032306</udiDi>
    <basicUdiDi>69449040004JMYO********Z5</basicUdiDi>
    <tradeName>MYO Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>CARDIAC MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002302-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:59.471Z</lastUpdated>
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    <udiDi>06944904053264</udiDi>
    <basicUdiDi>69449040004JMYO********Z5</basicUdiDi>
    <tradeName>Myoglobin (MYO) Kit (Particle-enhanced Immunoturbidimetric Assay Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004499-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:27.877Z</lastUpdated>
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  <row>
    <udiDi>06944904053271</udiDi>
    <basicUdiDi>69449040004JMYO********Z5</basicUdiDi>
    <tradeName>Myoglobin (MYO) Kit (Particle-enhanced Immunoturbidimetric Assay Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004500-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:27.848Z</lastUpdated>
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  <row>
    <udiDi>06944904065359</udiDi>
    <basicUdiDi>69449040004L-MYO*******P4</basicUdiDi>
    <tradeName>Myoglobin(CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-005678-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:25.775Z</lastUpdated>
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    <udiDi>06944904065472</udiDi>
    <basicUdiDi>69449040004L-MYO*******P4</basicUdiDi>
    <tradeName>Myoglobin Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>CARDIAC MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-005912-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:25.471Z</lastUpdated>
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    <udiDi>D-01R15226R</udiDi>
    <basicUdiDi>B-01R15226R</basicUdiDi>
    <tradeName>Alinity c Myoglobin Reagent Kit</tradeName>
    <deviceName>Alinity c Myoglobin Reagent Kit</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R1522</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:11:01.298Z</lastUpdated>
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    <udiDi>D-00001280717809BSD</udiDi>
    <basicUdiDi>B-00001280717809BSD</basicUdiDi>
    <tradeName>Myo Test Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Myo 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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT103</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:25.245Z</lastUpdated>
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    <udiDi>06939716405134</udiDi>
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    <tradeName>HOKAPI™ MYOGLOBIN</tradeName>
    <deviceName>HOKAPI™ MYOGLOBIN</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010702001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:55:00.614Z</lastUpdated>
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    <udiDi>06936415918668</udiDi>
    <basicUdiDi>69449040004JMYO********Z5</basicUdiDi>
    <tradeName>Myoglobin (MYO) Kit (Particle-enhanced Immunoturbidimetric Assay Method)</tradeName>
    <deviceName>Myoglobin Kit  (Particle-enhanced Immunoturbidimetric  Assay Method)、MYO Calibrator</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012735-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:39.379Z</lastUpdated>
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    <udiDi>06978465237085</udiDi>
    <basicUdiDi>697846523ProteinC14RN</basicUdiDi>
    <tradeName>Myoglobin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Myoglobin 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>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:32.460Z</lastUpdated>
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