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    <tradeName>tPAI·C Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)</tradeName>
    <deviceName>tPAI·C Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
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    <reference>tPAI·C706-AE10Y, tPAI·C706-AE10N, tPAI·C706-AE20Y, tPAI·C706-AE20N</reference>
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    <lastUpdated>2026-07-15T11:31:22.878Z</lastUpdated>
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    <deviceName>Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1  Complex Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
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    <legislation>IVDD</legislation>
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    <deviceName>Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1  Complex Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
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    <reference>50tests/kit</reference>
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    <tradeName>06972719603183</tradeName>
    <deviceName>Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1  Complex Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:42:11.922Z</lastUpdated>
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    <tradeName>06972719603176</tradeName>
    <deviceName>Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1  Complex Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:42:10.315Z</lastUpdated>
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    <tradeName>06972719603169</tradeName>
    <deviceName>Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1  Complex Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:42:09.510Z</lastUpdated>
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    <deviceName>Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1  Complex Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
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    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215450001</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:34:06.486Z</lastUpdated>
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    <udiDi>03607450009484</udiDi>
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    <tradeName>Asserachrom® tPA</tradeName>
    <deviceName>Asserachrom® tPA</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00948</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:58:50.657Z</lastUpdated>
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    <basicUdiDi>697846523OtherC04YZ</basicUdiDi>
    <tradeName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex 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>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:03.619Z</lastUpdated>
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    <udiDi>06978465236330</udiDi>
    <basicUdiDi>697846523OtherC04YZ</basicUdiDi>
    <tradeName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex 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>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:02.418Z</lastUpdated>
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    <udiDi>06978465236323</udiDi>
    <basicUdiDi>697846523OtherC04YZ</basicUdiDi>
    <tradeName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex 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>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:56.411Z</lastUpdated>
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    <udiDi>06978465236316</udiDi>
    <basicUdiDi>697846523OtherC04YZ</basicUdiDi>
    <tradeName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex 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>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:55.209Z</lastUpdated>
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    <udiDi>06978465236309</udiDi>
    <basicUdiDi>697846523OtherC04YZ</basicUdiDi>
    <tradeName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex 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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    <emdnCode>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:54.025Z</lastUpdated>
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    <udiDi>06942028501722</udiDi>
    <basicUdiDi>B-06942028501722</basicUdiDi>
    <tradeName>t-PAIC Assay Kit(Chemiluminescent Immunoassay)</tradeName>
    <deviceName>t-PAIC Assay Kit(Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DG0301</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:12.252Z</lastUpdated>
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