<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05415168008013</udiDi>
    <basicUdiDi>B-05415168008013</basicUdiDi>
    <tradeName>HDL Cholesterol</tradeName>
    <deviceName>HDL Cholesterol</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</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>HDLC-L00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:51:20.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415168008006</udiDi>
    <basicUdiDi>B-05415168008006</basicUdiDi>
    <tradeName>HDL Cholesterol</tradeName>
    <deviceName>HDL Cholesterol</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</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>HDLC-H00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:51:19.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415168007993</udiDi>
    <basicUdiDi>B-05415168007993</basicUdiDi>
    <tradeName>HDL Cholesterol</tradeName>
    <deviceName>HDL Cholesterol</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</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>HDLC-B00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:51:18.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156097611</udiDi>
    <basicUdiDi>8592156CCRE0027T5</basicUdiDi>
    <tradeName>HDL C DIRECT 240</tradeName>
    <deviceName>HDL CHOLESTEROL DIRECT</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</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>BLT00030</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:29:00.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156078856</udiDi>
    <basicUdiDi>8592156CCRE0026T3</basicUdiDi>
    <tradeName>HDL 80</tradeName>
    <deviceName>HDL DIRECT</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</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>BLT00028</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:28:35.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HDLCholesterolP4</udiDi>
    <basicUdiDi>B-HDLCholesterolP4</basicUdiDi>
    <tradeName>HDL Cholesterol</tradeName>
    <deviceName>HDL Cholesterol</deviceName>
    <manufacturerName>NS BIOTEC</manufacturerName>
    <manufacturerSrn>EG-MF-000032515</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Hdl-Mc-0150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:53:25.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HDL-C60185</udiDi>
    <basicUdiDi>B-HDL-C60185</basicUdiDi>
    <tradeName>High Density Lipoprotein Cholesterol Reagent Kit</tradeName>
    <deviceName>High Density Lipoprotein Cholesterol Reagent Kit</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HDL-C6011Y, HDL-C6012Y, HDL-C6013Y, HDL-C6014Y, HDL-C6015Y, HDL-C6011N, HDL-C6012N, HDL-C6013N, HDL-C6014N, HDL-C6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:53:24.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01061615X</udiDi>
    <basicUdiDi>B-ECH01061615X</basicUdiDi>
    <tradeName>D-ECH01061615X</tradeName>
    <deviceName>High Density Lipoprotein Cholesterol (HDL-C)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0106161</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:37:32.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01051615Q</udiDi>
    <basicUdiDi>B-ECH01051615Q</basicUdiDi>
    <tradeName>D-ECH01051615Q</tradeName>
    <deviceName>High Density Lipoprotein Cholesterol (HDL-C)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105161</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:36:32.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01041615H</udiDi>
    <basicUdiDi>B-ECH01041615H</basicUdiDi>
    <tradeName>D-ECH01041615H</tradeName>
    <deviceName>High Density Lipoprotein Cholesterol (HDL-C)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0104161</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:35:44.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01011614U</udiDi>
    <basicUdiDi>B-ECH01011614U</basicUdiDi>
    <tradeName>D-ECH01011614U</tradeName>
    <deviceName>High Density Lipoprotein Cholesterol (HDL-C)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101161</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:33:49.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-COLESTEROLO-HDLK5</udiDi>
    <basicUdiDi>B-COLESTEROLO-HDLK5</basicUdiDi>
    <tradeName>COLESTEROLO DIRETTO HDL LR</tradeName>
    <deviceName>COLESTEROLO DIRETTO HDL LR</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</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>FCC203-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:09:48.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0279M5</udiDi>
    <basicUdiDi>B-C0279M5</basicUdiDi>
    <tradeName>HDL Cholesterol</tradeName>
    <deviceName>HDL Cholesterol</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</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>C0279</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:50:14.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A15625U3</udiDi>
    <basicUdiDi>B-A15625U3</basicUdiDi>
    <tradeName>HDL Cholesterol Reagent HDL 2 x 200</tradeName>
    <deviceName>HDL Cholesterol Reagent HDL 2 x 200</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A15625</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:15:36.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-99H40TZA</udiDi>
    <basicUdiDi>B-99H40TZA</basicUdiDi>
    <tradeName>High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Homogeneous Determination Method)</tradeName>
    <deviceName>High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Homogeneous Determination Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99H40T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:59:30.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-99H40TSCY2</udiDi>
    <basicUdiDi>B-99H40TSCY2</basicUdiDi>
    <tradeName>High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Homogeneous Determination Method)</tradeName>
    <deviceName>High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Homogeneous Determination Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99H40TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:59:29.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-99H240TSCEU</udiDi>
    <basicUdiDi>B-99H240TSCEU</basicUdiDi>
    <tradeName>High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Homogeneous Determination Method)</tradeName>
    <deviceName>High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Homogeneous Determination Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99H240TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:59:29.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-99H240TDA</udiDi>
    <basicUdiDi>B-99H240TDA</basicUdiDi>
    <tradeName>High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Homogeneous Determination Method)</tradeName>
    <deviceName>High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Homogeneous Determination Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99H240T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:59:28.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>805361772061024</udiDi>
    <basicUdiDi>B-805361772061024</basicUdiDi>
    <tradeName>HDL PPT LS</tradeName>
    <deviceName>HDL PPT LS</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</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>CC1100; CC1101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:32:57.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>805361772060327</udiDi>
    <basicUdiDi>B-805361772060327</basicUdiDi>
    <tradeName>HDL Direct LS</tradeName>
    <deviceName>HDL Direct LS</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</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>CC1080; CC1090</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:32:56.631Z</lastUpdated>
  </row>
</eudamedExport>