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    <basicUdiDi>B-07791778046286</basicUdiDi>
    <tradeName>Thrombin Time</tradeName>
    <deviceName>Tiempo de Trombina</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:07:26.560Z</lastUpdated>
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    <udiDi>07791778046279</udiDi>
    <basicUdiDi>B-07791778046279</basicUdiDi>
    <tradeName>Coagulation Calibrator</tradeName>
    <deviceName>Coagulation Calibrator</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:07:25.760Z</lastUpdated>
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    <udiDi>07791778036904</udiDi>
    <basicUdiDi>B-07791778036904</basicUdiDi>
    <tradeName>Prothrombin Time plus</tradeName>
    <deviceName>Prothrombin Time plus</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1705027</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:07:20.957Z</lastUpdated>
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    <udiDi>07791778036638</udiDi>
    <basicUdiDi>B-07791778036638</basicUdiDi>
    <tradeName>APTT ellagic</tradeName>
    <deviceName>APTT ellagic</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1705010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:07:20.161Z</lastUpdated>
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  <row>
    <udiDi>07640175460082</udiDi>
    <basicUdiDi>B-07640175460082</basicUdiDi>
    <tradeName>Pefakit® Reptilase® Time</tradeName>
    <deviceName>Pefakit® Reptilase® Time</deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800191</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:44:09.930Z</lastUpdated>
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    <udiDi>07640175460075</udiDi>
    <basicUdiDi>B-07640175460075</basicUdiDi>
    <tradeName>Pefaclot®  UFH Controls</tradeName>
    <deviceName>Pefaclot®  UFH Controls</deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>505-60</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:44:05.586Z</lastUpdated>
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  <row>
    <udiDi>07640175460068</udiDi>
    <basicUdiDi>B-07640175460068</basicUdiDi>
    <tradeName>Pefaclot® UFH</tradeName>
    <deviceName>Pefaclot® UFH</deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020104</emdnCode>
    <emdnDescription>ACTIVATED CLOTTING TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>505-50</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:44:04.826Z</lastUpdated>
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  <row>
    <udiDi>07640175460051</udiDi>
    <basicUdiDi>B-07640175460051</basicUdiDi>
    <tradeName>Pefakit® APC-R Factor V Leiden Controls</tradeName>
    <deviceName>Pefakit® APC-R Factor V Leiden Controls</deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020610</emdnCode>
    <emdnDescription>APC RESISTANCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>502-21</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:44:03.913Z</lastUpdated>
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  <row>
    <udiDi>07640175460044</udiDi>
    <basicUdiDi>B-07640175460044</basicUdiDi>
    <tradeName>Pefakit® APC-R Faktor V Leiden</tradeName>
    <deviceName>Pefakit® APC-R Factor V Leiden</deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020610</emdnCode>
    <emdnDescription>APC RESISTANCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>502-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:44:03.108Z</lastUpdated>
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  <row>
    <udiDi>07640175460037</udiDi>
    <basicUdiDi>B-07640175460037</basicUdiDi>
    <tradeName>Batroxobin Time</tradeName>
    <deviceName>Batroxobin Time</deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09134867190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:43:59.108Z</lastUpdated>
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  <row>
    <udiDi>07613336155455</udiDi>
    <basicUdiDi>B-07613336155455</basicUdiDi>
    <tradeName>APCr Controls</tradeName>
    <deviceName>APC Resistance Controls</deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08045232190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:49:02.134Z</lastUpdated>
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  <row>
    <udiDi>07613336155448</udiDi>
    <basicUdiDi>B-07613336155448</basicUdiDi>
    <tradeName>APCr</tradeName>
    <deviceName>APC Resistance</deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020610</emdnCode>
    <emdnDescription>APC RESISTANCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08013934190</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:49:01.117Z</lastUpdated>
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  <row>
    <udiDi>07333051101109</udiDi>
    <basicUdiDi>B-07333051101109</basicUdiDi>
    <tradeName>Simple Simon PT</tradeName>
    <deviceName>Simple Simon PT</deviceName>
    <manufacturerName>Zafena AB</manufacturerName>
    <manufacturerSrn>SE-MF-000024138</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020801</emdnCode>
    <emdnDescription>PROTHROMBIN TIME RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZAF-101</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:22.444Z</lastUpdated>
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  <row>
    <udiDi>06979878281382</udiDi>
    <basicUdiDi>B-06979878281382</basicUdiDi>
    <tradeName>06979878281382</tradeName>
    <deviceName>D-Dimer Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001032</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:51:17.619Z</lastUpdated>
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    <udiDi>06979469760395</udiDi>
    <basicUdiDi>B-06979469760395</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2403CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:24.512Z</lastUpdated>
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    <udiDi>06979469760388</udiDi>
    <basicUdiDi>B-06979469760388</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2404CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:20.511Z</lastUpdated>
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    <udiDi>06979469760371</udiDi>
    <basicUdiDi>B-06979469760371</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2402CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:19.710Z</lastUpdated>
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    <udiDi>06979469760364</udiDi>
    <basicUdiDi>B-06979469760364</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2402CL</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:18.912Z</lastUpdated>
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    <udiDi>06979355921060</udiDi>
    <basicUdiDi>B-06979355921060</basicUdiDi>
    <tradeName>06979355921060</tradeName>
    <deviceName>D-Dimer 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>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:15.286Z</lastUpdated>
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    <udiDi>06979355921053</udiDi>
    <basicUdiDi>B-06979355921053</basicUdiDi>
    <tradeName>06979355921053</tradeName>
    <deviceName>D-Dimer 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>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:14.487Z</lastUpdated>
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