<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06944904024912</udiDi>
    <basicUdiDi>694490400045HDL-C******WE</basicUdiDi>
    <tradeName>HDL-Cholesterol Kit (Direct Method)</tradeName>
    <deviceName>HDL-Cholesterol Kit (Direct Method)</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000835-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:10.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153007330</udiDi>
    <basicUdiDi>6438153BU00133BM</basicUdiDi>
    <tradeName>HDL-Cholesterol</tradeName>
    <deviceName>HDL-Cholesterol</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981955</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:02:33.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>05204309175604</udiDi>
    <basicUdiDi>5204309000027NW</basicUdiDi>
    <tradeName>HDL-Cholesterol</tradeName>
    <deviceName>HDL-Cholesterol</deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1517-0240</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:25:54.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700817901</udiDi>
    <basicUdiDi>37017008CHDL004T</basicUdiDi>
    <tradeName>HDL CHOLESTEROL</tradeName>
    <deviceName>HDL CHOLESTEROL</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHDL-0250</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:50:33.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700802402</udiDi>
    <basicUdiDi>37017008CHDL014V</basicUdiDi>
    <tradeName>HDL CHOLESTEROL</tradeName>
    <deviceName>HDL CHOLESTEROL</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHDL-M330</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:49:18.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009994</udiDi>
    <basicUdiDi>361023ymz_c560hdlM2</basicUdiDi>
    <tradeName>Yumizen C560 HDL</tradeName>
    <deviceName>Yumizen C560 HDL</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300148017</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:18:19.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009987</udiDi>
    <basicUdiDi>361023ymz_chdlE7</basicUdiDi>
    <tradeName>Yumizen C HDL</tradeName>
    <deviceName>Yumizen C HDL</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300148016</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:17:59.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005743</udiDi>
    <basicUdiDi>361023pentra_hdl_directN8</basicUdiDi>
    <tradeName>ABX Pentra HDL Direct 100 CP</tradeName>
    <deviceName>ABX Pentra HDL Direct CP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01934</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:16:51.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230004999</udiDi>
    <basicUdiDi>361023pentra_hdl_directN8</basicUdiDi>
    <tradeName>ABX Pentra HDL Direct CP</tradeName>
    <deviceName>ABX Pentra HDL Direct CP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01636</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:14:52.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873042086</udiDi>
    <basicUdiDi>B-84352873042086</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>LDL-Cholesterol Direct</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR10290</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:58:52.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873042079</udiDi>
    <basicUdiDi>B-84352873042079</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>LDL-Cholesterol Direct</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR10292</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:58:51.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873042055</udiDi>
    <basicUdiDi>B-84352873042055</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>LDL-Cholesterol Direct</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT10290</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:58:48.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673939687</udiDi>
    <basicUdiDi>B-08431673939687</basicUdiDi>
    <tradeName>HDLc-D</tradeName>
    <deviceName>High density lipoprotein cholesterol</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD1001096</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:45:36.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673210977</udiDi>
    <basicUdiDi>B-08431673210977</basicUdiDi>
    <tradeName>HDLc-D</tradeName>
    <deviceName>High density lipoprotein cholesterol</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK1001097</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:44:43.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673210960</udiDi>
    <basicUdiDi>B-08431673210960</basicUdiDi>
    <tradeName>HDLc-D</tradeName>
    <deviceName>High density lipoprotein cholesterol</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK1001096</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:44:39.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673110970</udiDi>
    <basicUdiDi>B-08431673110970</basicUdiDi>
    <tradeName>HDLc-D</tradeName>
    <deviceName>High density lipoprotein cholesterol</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP1001097</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:44:14.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673110963</udiDi>
    <basicUdiDi>B-08431673110963</basicUdiDi>
    <tradeName>HDLc-D</tradeName>
    <deviceName>High density lipoprotein cholesterol</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP1001096</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:44:13.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673090289</udiDi>
    <basicUdiDi>B-08431673090289</basicUdiDi>
    <tradeName>HDLc-D</tradeName>
    <deviceName>High density lipoprotein cholesterol</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MX1001096</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:43:46.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673088095</udiDi>
    <basicUdiDi>B-08431673088095</basicUdiDi>
    <tradeName>HDLc-D</tradeName>
    <deviceName>High density lipoprotein cholesterol</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JL1001096</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:43:34.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673073794</udiDi>
    <basicUdiDi>B-08431673073794</basicUdiDi>
    <tradeName>HDLc-D</tradeName>
    <deviceName>High density lipoprotein cholesterol</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI1001096</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:43:21.996Z</lastUpdated>
  </row>
</eudamedExport>