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    <tradeName>Phosphoplastin RL</tradeName>
    <deviceName>Phosphoplastin RL</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:37.208Z</lastUpdated>
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    <basicUdiDi>B-10859394006023</basicUdiDi>
    <tradeName>Phosphoplastin RL</tradeName>
    <deviceName>Phosphoplastin RL</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>10859394006016</udiDi>
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    <tradeName>Phospholin ES</tradeName>
    <deviceName>Phospholin ES</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>08680952301138</udiDi>
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    <tradeName>Fibrinogen Reagent Kit</tradeName>
    <deviceName>Fibrinogen Reagent Kit</deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>.</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T09:28:03.558Z</lastUpdated>
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    <udiDi>08680952301121</udiDi>
    <basicUdiDi>B-08680952301121</basicUdiDi>
    <tradeName>APTT Activated Partial Thromboplastin Time Reagent Kit</tradeName>
    <deviceName>APTT Activated Partial Thromboplastin Time Reagent Kit</deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>.</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T09:28:02.735Z</lastUpdated>
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    <udiDi>08680952301114</udiDi>
    <basicUdiDi>B-08680952301114</basicUdiDi>
    <tradeName>PT-HS Prothrombin Time High Sensitivity Reagent Kit</tradeName>
    <deviceName>PT-HS Prothrombin Time High Sensitivity Reagent Kit</deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>.</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T09:28:01.945Z</lastUpdated>
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    <udiDi>D-084360388668668LB</udiDi>
    <basicUdiDi>B-084360388668668LB</basicUdiDi>
    <tradeName>APTT, R1 5 x 4 mL, R2 5 x 4 mL</tradeName>
    <deviceName>APTT, R1 5 x 4 mL, R2 5 x 4 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104-0020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:33:18.603Z</lastUpdated>
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  <row>
    <udiDi>D-084360388648644K7</udiDi>
    <basicUdiDi>B-084360388648644K7</basicUdiDi>
    <tradeName>Prothrombin Time, 4 x 4 mL</tradeName>
    <deviceName>Prothrombin Time, 4 x 4 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104-0017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:33:16.199Z</lastUpdated>
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    <udiDi>08435287106503</udiDi>
    <basicUdiDi>B-08435287106503</basicUdiDi>
    <tradeName>08435287106503</tradeName>
    <deviceName>ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61009</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:42:17.838Z</lastUpdated>
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    <udiDi>08435287100242</udiDi>
    <basicUdiDi>B-08435287100242</basicUdiDi>
    <tradeName>08435287100242</tradeName>
    <deviceName>ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:40:38.664Z</lastUpdated>
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    <udiDi>08435287100235</udiDi>
    <basicUdiDi>B-08435287100235</basicUdiDi>
    <tradeName>08435287100235</tradeName>
    <deviceName>ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:40:35.472Z</lastUpdated>
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    <udiDi>08435287100204</udiDi>
    <basicUdiDi>B-08435287100204</basicUdiDi>
    <tradeName>08435287100204</tradeName>
    <deviceName>PROTHROMBIN TIME (PT)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:40:32.253Z</lastUpdated>
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    <udiDi>08435287100198</udiDi>
    <basicUdiDi>B-08435287100198</basicUdiDi>
    <tradeName>08435287100198</tradeName>
    <deviceName>THROMBIN TIME (TT)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:40:28.265Z</lastUpdated>
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    <udiDi>07798100042718</udiDi>
    <basicUdiDi>B-07798100042718</basicUdiDi>
    <tradeName>Tiempo de Trombina</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>Artık piyasada değil</deviceStatus>
    <reference>1705009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:36.609Z</lastUpdated>
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    <udiDi>07798100042688</udiDi>
    <basicUdiDi>B-07798100042688</basicUdiDi>
    <tradeName>APTTest ellágico</tradeName>
    <deviceName>APTTest ellágico</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1705004</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:32.173Z</lastUpdated>
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    <udiDi>07798100042664</udiDi>
    <basicUdiDi>B-07798100042664</basicUdiDi>
    <tradeName>Soluplastin</tradeName>
    <deviceName>Soluplastin</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
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    <reference>1705003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:32.149Z</lastUpdated>
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    <tradeName>Soluplastin</tradeName>
    <deviceName>Soluplastin</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
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    <reference>1705005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:32.146Z</lastUpdated>
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    <udiDi>07798100042657</udiDi>
    <basicUdiDi>B-07798100042657</basicUdiDi>
    <tradeName>APTTest</tradeName>
    <deviceName>APTTest</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
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    <reference>1705002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>Soluplastin</tradeName>
    <deviceName>Soluplastin</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1705001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:25.401Z</lastUpdated>
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    <basicUdiDi>B-07798100040059</basicUdiDi>
    <tradeName>APTT ellagic</tradeName>
    <deviceName>APTTest ellágico</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:17.406Z</lastUpdated>
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