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    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
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    <tradeName>Cromatest</tradeName>
    <deviceName>Plasma Protein Control (N-I)</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
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    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
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    <tradeName>BIOPHEN™ Abnormal Control Plasma</tradeName>
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    <manufacturerName>HYPHEN BioMed</manufacturerName>
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    <lastUpdated>2026-07-24T19:55:45.969Z</lastUpdated>
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    <tradeName>BIOPHEN™ Normal Control Plasma</tradeName>
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    <manufacturerName>HYPHEN BioMed</manufacturerName>
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    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223201</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:55:44.365Z</lastUpdated>
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    <udiDi>03663537082306</udiDi>
    <basicUdiDi>366353700025B5</basicUdiDi>
    <tradeName>EASYPLASMA™ Control Set</tradeName>
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    <manufacturerName>HYPHEN BioMed</manufacturerName>
    <manufacturerSrn>FR-MF-000002214</manufacturerSrn>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225601</reference>
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    <lastUpdated>2026-07-24T19:51:11.304Z</lastUpdated>
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    <udiDi>03663537085819</udiDi>
    <basicUdiDi>366353700025B5</basicUdiDi>
    <tradeName>Revohem™ Control 2 Lite</tradeName>
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    <manufacturerName>HYPHEN BioMed</manufacturerName>
    <manufacturerSrn>FR-MF-000002214</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQ518931</reference>
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    <lastUpdated>2026-07-24T19:51:10.904Z</lastUpdated>
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    <udiDi>03663537085826</udiDi>
    <basicUdiDi>366353700025B5</basicUdiDi>
    <tradeName>Revohem™ Control 2 Pro</tradeName>
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    <manufacturerName>HYPHEN BioMed</manufacturerName>
    <manufacturerSrn>FR-MF-000002214</manufacturerSrn>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AY003713</reference>
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    <lastUpdated>2026-07-24T19:51:10.758Z</lastUpdated>
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    <udiDi>03663537085802</udiDi>
    <basicUdiDi>366353700034B6</basicUdiDi>
    <tradeName>Revohem™ Control 1 Pro</tradeName>
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    <manufacturerName>HYPHEN BioMed</manufacturerName>
    <manufacturerSrn>FR-MF-000002214</manufacturerSrn>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV510350</reference>
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    <lastUpdated>2026-07-24T19:51:10.593Z</lastUpdated>
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    <udiDi>03663537085796</udiDi>
    <basicUdiDi>366353700034B6</basicUdiDi>
    <tradeName>Revohem™ Control 1 Lite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HYPHEN BioMed</manufacturerName>
    <manufacturerSrn>FR-MF-000002214</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CX721693</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:51:10.016Z</lastUpdated>
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    <udiDi>06974925050720</udiDi>
    <basicUdiDi>B-06974925050720</basicUdiDi>
    <tradeName>Coagulation Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhengzhou Bioyuan Biotech Co. Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021426</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BYZKF0303</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-24T11:49:52.377Z</lastUpdated>
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    <udiDi>06974925050683</udiDi>
    <basicUdiDi>B-06974925050683</basicUdiDi>
    <tradeName>Coagulation Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhengzhou Bioyuan Biotech Co. Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021426</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BYZKF0203</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-24T11:49:51.587Z</lastUpdated>
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    <udiDi>06974925050645</udiDi>
    <basicUdiDi>B-06974925050645</basicUdiDi>
    <tradeName>Coagulation Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhengzhou Bioyuan Biotech Co. Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021426</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BYZKF0103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-24T11:49:50.790Z</lastUpdated>
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    <udiDi>08431673791148</udiDi>
    <basicUdiDi>B-08431673791148</basicUdiDi>
    <tradeName>D-DIMER CONTROL</tradeName>
    <deviceName>D-Dimer Control</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1709114</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:25:21.475Z</lastUpdated>
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    <udiDi>08431673791117</udiDi>
    <basicUdiDi>B-08431673791117</basicUdiDi>
    <tradeName>D-DIMER CAL</tradeName>
    <deviceName>D-Dimer Calibrator</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</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>1709111</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:25:20.274Z</lastUpdated>
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    <udiDi>09120036863859</udiDi>
    <basicUdiDi>B-09120036863859</basicUdiDi>
    <tradeName>09120036863859</tradeName>
    <deviceName>Technoview Edoxaban CON H</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5090253</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:52.069Z</lastUpdated>
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    <udiDi>09120036863842</udiDi>
    <basicUdiDi>B-09120036863842</basicUdiDi>
    <tradeName>09120036863842</tradeName>
    <deviceName>Technoview Edoxaban CON M</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5090252</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:49.653Z</lastUpdated>
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    <udiDi>09120036863835</udiDi>
    <basicUdiDi>B-09120036863835</basicUdiDi>
    <tradeName>09120036863835</tradeName>
    <deviceName>Technoview Edoxaban CON L</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5090251</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:48.852Z</lastUpdated>
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    <udiDi>09120036863828</udiDi>
    <basicUdiDi>B-09120036863828</basicUdiDi>
    <tradeName>09120036863828</tradeName>
    <deviceName>Technoview Edoxaban CAL</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5090250</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:48.053Z</lastUpdated>
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    <udiDi>09120036863620</udiDi>
    <basicUdiDi>B-09120036863620</basicUdiDi>
    <tradeName>09120036863620</tradeName>
    <deviceName>TECHNOCLOT® PT Owren Capillary Control Set</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5005102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:43.268Z</lastUpdated>
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    <tradeName>09120036863613</tradeName>
    <deviceName>TECHNOCLOT® PT Owren Capillary Calibration Set</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></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>5005100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:39.246Z</lastUpdated>
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