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    <udiDi>08683347941025</udiDi>
    <basicUdiDi>B-08683347941025</basicUdiDi>
    <tradeName>RapidFor™ D-Dimer Rapid Test Kit (FIA)</tradeName>
    <deviceName>D-Dimer Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:03:46.398Z</lastUpdated>
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    <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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    <udiDi>06978896415496</udiDi>
    <basicUdiDi>B-06978896415496</basicUdiDi>
    <tradeName>06978896415496</tradeName>
    <deviceName>D-Dimer Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-DD-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:10.098Z</lastUpdated>
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    <udiDi>06978896415489</udiDi>
    <basicUdiDi>B-06978896415489</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Immunofluorescence Method)</tradeName>
    <deviceName>D-Dimer Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-DD-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:06.094Z</lastUpdated>
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    <udiDi>06977903345429</udiDi>
    <basicUdiDi>B-06977903345429</basicUdiDi>
    <tradeName>06977903345429</tradeName>
    <deviceName>D-Dimer FIA</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS120701C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:34:23.328Z</lastUpdated>
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    <udiDi>06977903345412</udiDi>
    <basicUdiDi>B-06977903345412</basicUdiDi>
    <tradeName>06977903345412</tradeName>
    <deviceName>D-Dimer FIA</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS120701C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:34:22.515Z</lastUpdated>
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    <udiDi>06975838801232</udiDi>
    <basicUdiDi>B-06975838801232</basicUdiDi>
    <tradeName>06975838801232</tradeName>
    <deviceName>FDP Controls</deviceName>
    <manufacturerName>Zhejiang Pushkang Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042656</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE50124</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:12:54.273Z</lastUpdated>
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    <udiDi>06975838801225</udiDi>
    <basicUdiDi>B-06975838801225</basicUdiDi>
    <tradeName>06975838801225</tradeName>
    <deviceName>Antithrombin Ⅲ Controls</deviceName>
    <manufacturerName>Zhejiang Pushkang Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042656</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE50003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:12:39.024Z</lastUpdated>
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  <row>
    <udiDi>06975260986989</udiDi>
    <basicUdiDi>B-06975260986989</basicUdiDi>
    <tradeName>06975260986989</tradeName>
    <deviceName>D-Dimer Test Kit (Dry Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Lansion Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001086</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0005-03</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:24:12.535Z</lastUpdated>
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    <udiDi>06975132462917</udiDi>
    <basicUdiDi>B-06975132462917</basicUdiDi>
    <tradeName>06975132462917</tradeName>
    <deviceName>D-Dimer Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>Jiangsu Accuracy Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004533</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDD-402F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:59:16.897Z</lastUpdated>
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  <row>
    <udiDi>06975068491289</udiDi>
    <basicUdiDi>B-06975068491289</basicUdiDi>
    <tradeName>Diagnostic Kit for D-Dimer (Immunochromatographic assay)</tradeName>
    <deviceName>Diagnostic Kit for D-Dimer (Immunochromatographic assay)</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP004.B2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:32:25.393Z</lastUpdated>
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  <row>
    <udiDi>06975068490534</udiDi>
    <basicUdiDi>B-06975068490534</basicUdiDi>
    <tradeName>Diagnostic Kit for D-Dimer（Immunochromatographic assay）</tradeName>
    <deviceName>Diagnostic Kit for D-Dimer（Immunochromatographic assay）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP004.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:31:13.304Z</lastUpdated>
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  <row>
    <udiDi>06974703166308</udiDi>
    <basicUdiDi>B-06974703166308</basicUdiDi>
    <tradeName>mLabs® D-Dimer</tradeName>
    <deviceName>mLabs® D-Dimer</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:14.087Z</lastUpdated>
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    <udiDi>06974703160795</udiDi>
    <basicUdiDi>B-06974703160795</basicUdiDi>
    <tradeName>qLabs® PT-INR Owren (Dry) Test Strips</tradeName>
    <deviceName>qLabs® PT-INR Owren (Dry) Test Strips</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020801</emdnCode>
    <emdnDescription>PROTHROMBIN TIME RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-2 Pro</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:11.673Z</lastUpdated>
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    <udiDi>06974703160788</udiDi>
    <basicUdiDi>B-06974703160788</basicUdiDi>
    <tradeName>qLabs® PT-INR Owren (Dry) Test Strips</tradeName>
    <deviceName>qLabs® PT-INR Owren (Dry) Test Strips</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020801</emdnCode>
    <emdnDescription>PROTHROMBIN TIME RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-2</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:55.602Z</lastUpdated>
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    <udiDi>06974703160764</udiDi>
    <basicUdiDi>B-06974703160764</basicUdiDi>
    <tradeName>qLabs® Multi-level Coag Controls</tradeName>
    <deviceName>qLabs® Multi-level Coag Controls</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-6-CL Pro</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:54.791Z</lastUpdated>
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    <udiDi>06974703160757</udiDi>
    <basicUdiDi>B-06974703160757</basicUdiDi>
    <tradeName>qLabs® Coag Panel 4 Test Strips</tradeName>
    <deviceName>qLabs® Coag Panel 4 Test Strips</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020899</emdnCode>
    <emdnDescription>HAEMOSTASIS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-6 Pro</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:53.195Z</lastUpdated>
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    <udiDi>06974703160269</udiDi>
    <basicUdiDi>B-06974703160269</basicUdiDi>
    <tradeName>qLabs® FIB Test Strips</tradeName>
    <deviceName>qLabs® FIB Test Strips</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020899</emdnCode>
    <emdnDescription>HAEMOSTASIS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-18 Pro</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:50.803Z</lastUpdated>
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    <udiDi>06974703160207</udiDi>
    <basicUdiDi>B-06974703160207</basicUdiDi>
    <tradeName>qLabs® APTT Liquid Control</tradeName>
    <deviceName>qLabs® APTT Liquid Control</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-9-CL Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:46.791Z</lastUpdated>
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    <udiDi>06974703160191</udiDi>
    <basicUdiDi>B-06974703160191</basicUdiDi>
    <tradeName>qLabs® Coag Panel 2 Liquid Control</tradeName>
    <deviceName>qLabs® Coag Panel 2 Liquid Control</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-4-CL Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:44.451Z</lastUpdated>
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