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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT01103E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-17T02:58:44.953Z</lastUpdated>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
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    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT01102E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-17T02:58:41.947Z</lastUpdated>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
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    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT01304E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-17T02:56:08.848Z</lastUpdated>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
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    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT01303E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-17T02:55:25.737Z</lastUpdated>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT01302E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-17T02:55:22.228Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT01503E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-17T02:21:01.128Z</lastUpdated>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
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    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT01502E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-17T02:20:55.362Z</lastUpdated>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
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    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT01405E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-17T01:43:13.577Z</lastUpdated>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT01404E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-17T01:43:10.558Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT01403E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-17T00:27:11.430Z</lastUpdated>
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    <udiDi>06926802615492</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT01402E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T23:09:37.629Z</lastUpdated>
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    <udiDi>06926802606469</udiDi>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL10703E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:59:17.540Z</lastUpdated>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL10702E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:59:14.525Z</lastUpdated>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
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    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
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    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL10803E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:58:03.447Z</lastUpdated>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
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    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
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    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL10802E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:55:32.283Z</lastUpdated>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
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    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152004</emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL14301E</reference>
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    <lastUpdated>2026-06-16T22:54:21.427Z</lastUpdated>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL14002E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:52:12.331Z</lastUpdated>
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    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
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    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL14001E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:49:35.420Z</lastUpdated>
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