<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CNMF000014455-BF-C063N7</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C063N7</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C063N7</tradeName>
    <deviceName>D-Dimer Quality Control</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C063</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:33.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C062N5</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C062N5</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C062N5</tradeName>
    <deviceName>D-Dimer Quality Control</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C062</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:32.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C061N3</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C061N3</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C061N3</tradeName>
    <deviceName>D-Dimer Quality Control</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C061</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:25.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST1800E4</udiDi>
    <basicUdiDi>B-ST1800E4</basicUdiDi>
    <tradeName>PT (INR) control kit</tradeName>
    <deviceName>PT (INR) control kit</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST1800</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:43:44.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST1500DM</udiDi>
    <basicUdiDi>B-ST1500DM</basicUdiDi>
    <tradeName>D-Dimer control kit</tradeName>
    <deviceName>D-Dimer control kit</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST1500</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:43:37.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDDDI-PN20YZ</udiDi>
    <basicUdiDi>B-FDDDI-PN20YZ</basicUdiDi>
    <tradeName>D-Dimer Control</tradeName>
    <deviceName>D-Dimer Control</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDDDI-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:20:24.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDDDI-PN20HG3D</udiDi>
    <basicUdiDi>B-FDDDI-PN20HG3D</basicUdiDi>
    <tradeName>D-Dimer Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDDDI-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:20:20.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245127</udiDi>
    <basicUdiDi>B-15065026245127</basicUdiDi>
    <tradeName>TruHemo</tradeName>
    <deviceName>Coag Abnormal Control</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TH10010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:16.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245110</udiDi>
    <basicUdiDi>B-15065026245110</basicUdiDi>
    <tradeName>TruHemo</tradeName>
    <deviceName>Coag Normal Control</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TH10009</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:15.635Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>10627966005282</udiDi>
    <basicUdiDi>B-10627966005282</basicUdiDi>
    <tradeName>RAMP Total b-hCG Controls Level 2</tradeName>
    <deviceName>RAMP Total b-hCG Controls - Level 2</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>C4003-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:21:02.752Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>06974703160184</udiDi>
    <basicUdiDi>B-06974703160184</basicUdiDi>
    <tradeName>qLabs® PT-INR Liquid Control</tradeName>
    <deviceName>qLabs® PT-INR 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-1-CL Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:42.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438115001645</udiDi>
    <basicUdiDi>B-06438115001645</basicUdiDi>
    <tradeName>QuikRead CRP Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>154812</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:08:08.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438115001560</udiDi>
    <basicUdiDi>B-06438115001560</basicUdiDi>
    <tradeName>QuikRead go HbA1c Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>154520</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:08:06.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438115001515</udiDi>
    <basicUdiDi>B-06438115001515</basicUdiDi>
    <tradeName>QuikRead go CRP Control Low</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153765</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:08:01.819Z</lastUpdated>
  </row>
</eudamedExport>