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    <deviceName>Troponin I (cTnI ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:30:22.751Z</lastUpdated>
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    <udiDi>06979355927734</udiDi>
    <basicUdiDi>B-06979355927734</basicUdiDi>
    <tradeName>06979355927734</tradeName>
    <deviceName>Troponin I (cTnI ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:30:21.959Z</lastUpdated>
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    <udiDi>06979355927741</udiDi>
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    <tradeName>06979355927741</tradeName>
    <deviceName>Troponin I (cTnI ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:30:20.359Z</lastUpdated>
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    <udiDi>06979355920667</udiDi>
    <basicUdiDi>B-06979355920667</basicUdiDi>
    <tradeName>06979355920667</tradeName>
    <deviceName>Troponin I (cTnI)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:01:25.838Z</lastUpdated>
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    <udiDi>06979355920650</udiDi>
    <basicUdiDi>B-06979355920650</basicUdiDi>
    <tradeName>06979355920650</tradeName>
    <deviceName>Troponin I (cTnI)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:01:24.819Z</lastUpdated>
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    <udiDi>06979355920643</udiDi>
    <basicUdiDi>B-06979355920643</basicUdiDi>
    <tradeName>06979355920643</tradeName>
    <deviceName>Troponin I (cTnI)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:01:23.214Z</lastUpdated>
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    <udiDi>06979355920636</udiDi>
    <basicUdiDi>B-06979355920636</basicUdiDi>
    <tradeName>06979355920636</tradeName>
    <deviceName>Troponin I (cTnI)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:01:20.828Z</lastUpdated>
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    <udiDi>06979355920629</udiDi>
    <basicUdiDi>B-06979355920629</basicUdiDi>
    <tradeName>06979355920629</tradeName>
    <deviceName>Troponin I (cTnI)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:01:19.209Z</lastUpdated>
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    <udiDi>06979355920612</udiDi>
    <basicUdiDi>B-06979355920612</basicUdiDi>
    <tradeName>06979355920612</tradeName>
    <deviceName>Troponin I (cTnI)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:01:18.418Z</lastUpdated>
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    <udiDi>06978198482103</udiDi>
    <basicUdiDi>B-06978198482103</basicUdiDi>
    <tradeName>High-sensitivity Cardiac Troponin I (Hs-cTnI) Test Kit (Immunofluorescence)</tradeName>
    <deviceName>High-sensitivity Cardiac Troponin I (Hs-cTnI) Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:42:27.611Z</lastUpdated>
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    <udiDi>06978139075784</udiDi>
    <basicUdiDi>B-06978139075784</basicUdiDi>
    <tradeName>Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:40:05.901Z</lastUpdated>
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    <udiDi>06977565580848</udiDi>
    <basicUdiDi>B-06977565580848</basicUdiDi>
    <tradeName>cTnI Rapid Quantitative Test</tradeName>
    <deviceName>cTnI Rapid Quantitative Test</deviceName>
    <manufacturerName>Coei Biotech Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049509</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0842</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:21:21.200Z</lastUpdated>
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    <udiDi>06976968300718</udiDi>
    <basicUdiDi>B-06976968300718</basicUdiDi>
    <tradeName>Cardiac Troponin I(cTnI) Determination Kit(Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Cardiac Troponin I(cTnI) Determination Kit(Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Channel Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053778</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR024EU01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:10:59.912Z</lastUpdated>
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    <udiDi>06976753472774</udiDi>
    <basicUdiDi>B-06976753472774</basicUdiDi>
    <tradeName>High Sensitivity Cardiac Troponin I Rapid Test Device  (whole blood/serum/plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E020501D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:10.519Z</lastUpdated>
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    <udiDi>06976753472057</udiDi>
    <basicUdiDi>B-06976753472057</basicUdiDi>
    <tradeName>High Sensitive Cardiac Troponin I (hs-cTnI) Assay Reagent Kit (CMIA) for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KL006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:57:26.413Z</lastUpdated>
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    <udiDi>06975984067643</udiDi>
    <basicUdiDi>B-06975984067643</basicUdiDi>
    <tradeName>Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320300503</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:22:30.785Z</lastUpdated>
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    <udiDi>06975984067636</udiDi>
    <basicUdiDi>B-06975984067636</basicUdiDi>
    <tradeName>Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320300502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:22:29.187Z</lastUpdated>
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    <udiDi>06975984067629</udiDi>
    <basicUdiDi>B-06975984067629</basicUdiDi>
    <tradeName>Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320300501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:22:28.389Z</lastUpdated>
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    <udiDi>06975984063317</udiDi>
    <basicUdiDi>B-06975984063317</basicUdiDi>
    <tradeName>High-Sensitivity Troponin T STAT (hs-cTnT STAT) eCLIA</tradeName>
    <deviceName>High-Sensitivity Troponin T STAT (hs-cTnT STAT) eCLIA</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>691032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:18:30.528Z</lastUpdated>
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    <basicUdiDi>B-06975984063300</basicUdiDi>
    <tradeName>High-Sensitivity Troponin T STAT (hs-cTnT STAT) eCLIA</tradeName>
    <deviceName>High-Sensitivity Troponin T STAT (hs-cTnT STAT) eCLIA</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>691030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:18:29.721Z</lastUpdated>
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