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    <tradeName>Pool Norm</tradeName>
    <deviceName>Pool Norm</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030299</emdnCode>
    <emdnDescription>HAEMOSTASIS REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00539</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:50:04.690Z</lastUpdated>
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    <udiDi>13607450003151</udiDi>
    <basicUdiDi>B-13607450003151</basicUdiDi>
    <tradeName>STA® - ImmunoDef XII</tradeName>
    <deviceName>STA® - ImmunoDef XII</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020211</emdnCode>
    <emdnDescription>COAGULATION FACTOR XII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00315</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:50:03.885Z</lastUpdated>
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    <udiDi>D-1117613066592Z</udiDi>
    <basicUdiDi>B-1117613066592Z</basicUdiDi>
    <tradeName>D-1117613066592Z</tradeName>
    <deviceName>LIODetect® D-Dimer Rapid Test</deviceName>
    <manufacturerName>Lionex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D-Dimer_10_EN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:47:49.445Z</lastUpdated>
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    <udiDi>10859394006238</udiDi>
    <basicUdiDi>B-10859394006238</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21-405</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:10.070Z</lastUpdated>
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    <udiDi>10859394006160</udiDi>
    <basicUdiDi>B-10859394006160</basicUdiDi>
    <tradeName>NoFact IX</tradeName>
    <deviceName>NoFact IX</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020208</emdnCode>
    <emdnDescription>COAGULATION FACTOR IX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>69-201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:06.070Z</lastUpdated>
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    <udiDi>10859394006153</udiDi>
    <basicUdiDi>B-10859394006153</basicUdiDi>
    <tradeName>NoFact VIII</tradeName>
    <deviceName>NoFact VIII</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020207</emdnCode>
    <emdnDescription>COAGULATION FACTOR VIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>68-201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:05.268Z</lastUpdated>
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    <udiDi>10859394006146</udiDi>
    <basicUdiDi>B-10859394006146</basicUdiDi>
    <tradeName>LupoTek KCT</tradeName>
    <deviceName>LupoTek KCT</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>87-305</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:04.468Z</lastUpdated>
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    <udiDi>10859394006139</udiDi>
    <basicUdiDi>B-10859394006139</basicUdiDi>
    <tradeName>PlasmaCon LA</tradeName>
    <deviceName>PlasmaCon LA</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>150-201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:03.664Z</lastUpdated>
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    <udiDi>10859394006115</udiDi>
    <basicUdiDi>B-10859394006115</basicUdiDi>
    <tradeName>LupoTek Correctin VL</tradeName>
    <deviceName>LupoTek Correctin VL</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86-201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:59.693Z</lastUpdated>
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    <udiDi>10859394006108</udiDi>
    <basicUdiDi>B-10859394006108</basicUdiDi>
    <tradeName>LupoTek Detectin VL</tradeName>
    <deviceName>LupoTek Detectin VL</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85-202</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:58.957Z</lastUpdated>
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    <udiDi>10859394006085</udiDi>
    <basicUdiDi>B-10859394006085</basicUdiDi>
    <tradeName>PlasmaCon L2</tradeName>
    <deviceName>PlasmaCon L2</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32-201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:43.607Z</lastUpdated>
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    <udiDi>10859394006078</udiDi>
    <basicUdiDi>B-10859394006078</basicUdiDi>
    <tradeName>PlasmaCon L1</tradeName>
    <deviceName>PlasmaCon L1</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31-201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:42.794Z</lastUpdated>
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    <udiDi>10859394006061</udiDi>
    <basicUdiDi>B-10859394006061</basicUdiDi>
    <tradeName>PlasmaCon N</tradeName>
    <deviceName>PlasmaCon N</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:41.986Z</lastUpdated>
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    <udiDi>10859394006054</udiDi>
    <basicUdiDi>B-10859394006054</basicUdiDi>
    <tradeName>T-Tek</tradeName>
    <deviceName>T-Tek</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</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>50-201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:41.214Z</lastUpdated>
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    <udiDi>10859394006030</udiDi>
    <basicUdiDi>B-10859394006030</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>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-310</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:37.208Z</lastUpdated>
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    <udiDi>10859394006023</udiDi>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-305</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:36.399Z</lastUpdated>
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    <udiDi>10859394006016</udiDi>
    <basicUdiDi>B-10859394006016</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21-410</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:35.582Z</lastUpdated>
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    <udiDi>10859394006009</udiDi>
    <basicUdiDi>B-10859394006009</basicUdiDi>
    <tradeName>Emicizumab Calibrator</tradeName>
    <deviceName>Emicizumab Calibrator</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</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>151-201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:34.801Z</lastUpdated>
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    <udiDi>10850076346284</udiDi>
    <basicUdiDi>B-10850076346284</basicUdiDi>
    <tradeName>D-Dimer Test Kit (CLIA)</tradeName>
    <deviceName>D-Dimer Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDDDI-301a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:39:42.549Z</lastUpdated>
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    <udiDi>10627966005312</udiDi>
    <basicUdiDi>B-10627966005312</basicUdiDi>
    <tradeName>RAMP Total b-hCG Controls Level 1</tradeName>
    <deviceName>RAMP Total b-hCG Controls - Level 1</deviceName>
    <manufacturerName>Response Biomedical Corp.</manufacturerName>
    <manufacturerSrn>CA-MF-000034747</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080502</emdnCode>
    <emdnDescription>HAEMOSTASIS STANDARDS AND CALIBRATORS RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>C4003-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:21:03.556Z</lastUpdated>
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