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    <tradeName>PT Multi-Calibrator</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_KIT_PT-Multi_Cal</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-15T21:02:48.352Z</lastUpdated>
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    <basicUdiDi>0405686900193V9</basicUdiDi>
    <tradeName>Standard Human Plasma</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
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    <lastUpdated>2026-07-15T21:02:29.935Z</lastUpdated>
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    <udiDi>D-EBL2183005AA</udiDi>
    <basicUdiDi>B-EBL2183005AA</basicUdiDi>
    <tradeName>D-EBL2183005AA</tradeName>
    <deviceName>D-Dimer Calibrator</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <lastUpdated>2026-07-13T15:23:09.766Z</lastUpdated>
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    <udiDi>D-EBL2182005A3</udiDi>
    <basicUdiDi>B-EBL2182005A3</basicUdiDi>
    <tradeName>D-EBL2182005A3</tradeName>
    <deviceName>D-Dimer Calibrator</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2182005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:08.981Z</lastUpdated>
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    <udiDi>D-EBL21810069W</udiDi>
    <basicUdiDi>B-EBL21810069W</basicUdiDi>
    <tradeName>D-EBL21810069W</tradeName>
    <deviceName>Fibrinogen Degradation Product (FDP) Calibrator</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2181006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:08.165Z</lastUpdated>
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    <udiDi>D-EBL21810059U</udiDi>
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    <tradeName>D-EBL21810059U</tradeName>
    <deviceName>D-Dimer Calibrator</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2181005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:02.564Z</lastUpdated>
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    <udiDi>D-CAL-P8200-005XX</udiDi>
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    <tradeName>TECal DD</tradeName>
    <deviceName>CAL</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P8200-005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:26.861Z</lastUpdated>
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    <udiDi>D-CAL-P8001-005X8</udiDi>
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    <tradeName>TECal N</tradeName>
    <deviceName>CAL</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P8001-005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:26.062Z</lastUpdated>
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    <udiDi>27350060320394</udiDi>
    <basicUdiDi>B-27350060320394</basicUdiDi>
    <tradeName>MRX vWF Antigen Calibrator</tradeName>
    <deviceName>vWF Antigen Calibrator</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5053</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:30.976Z</lastUpdated>
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    <udiDi>27350060320387</udiDi>
    <basicUdiDi>B-27350060320387</basicUdiDi>
    <tradeName>MRX Protein C Calibrator</tradeName>
    <deviceName>Protein C Calibrator</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5023</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:28.609Z</lastUpdated>
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    <udiDi>27350060320356</udiDi>
    <basicUdiDi>B-27350060320356</basicUdiDi>
    <tradeName>MRX FDP Clear Calibrator Set</tradeName>
    <deviceName>FDP Clear Calibrator Set</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5017</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:26.971Z</lastUpdated>
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    <udiDi>27350060320349</udiDi>
    <basicUdiDi>B-27350060320349</basicUdiDi>
    <tradeName>MRX Free Protein S Calibrator</tradeName>
    <deviceName>Free Protein S Calibrator</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5044</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:26.195Z</lastUpdated>
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    <udiDi>27350060320332</udiDi>
    <basicUdiDi>B-27350060320332</basicUdiDi>
    <tradeName>MRX PT Quick (INR) Calibrator Set</tradeName>
    <deviceName>PT Quick (INR) Calibrator Set</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5043</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:24.589Z</lastUpdated>
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    <udiDi>27350060320325</udiDi>
    <basicUdiDi>B-27350060320325</basicUdiDi>
    <tradeName>MRX Fib Clauss Calibrator</tradeName>
    <deviceName>Fib Clauss Calibrator</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5042</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:22.190Z</lastUpdated>
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    <udiDi>27350060320318</udiDi>
    <basicUdiDi>B-27350060320318</basicUdiDi>
    <tradeName>MRX Antithrombin Calibrator</tradeName>
    <deviceName>Antithrombin Calibrator</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5041</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:20.584Z</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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>151-201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:34.801Z</lastUpdated>
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    <udiDi>D-084360388678675LK</udiDi>
    <basicUdiDi>B-084360388678675LK</basicUdiDi>
    <tradeName>Coagulation calibrator</tradeName>
    <deviceName>Coagulation calibrator, 4 x 1 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104-0021</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:33:21.002Z</lastUpdated>
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    <tradeName>08435287108996</tradeName>
    <deviceName>D-DIMER STANDARD</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <lastUpdated>2026-07-07T20:43:03.538Z</lastUpdated>
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    <deviceName>D-DIMER CONTROLS I / II</deviceName>
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    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
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    <lastUpdated>2026-07-07T20:42:59.533Z</lastUpdated>
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    <deviceName>FIBRINOGEN STANDARD</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31601</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:40:54.726Z</lastUpdated>
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