<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-Lpa601U4</udiDi>
    <basicUdiDi>B-Lpa601U4</basicUdiDi>
    <tradeName>Lipoprotein (a) Reagent Kit</tradeName>
    <deviceName>Lipoprotein (a) 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>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lpa6011Y, Lpa6012Y, Lpa6013Y, Lpa6014Y, Lpa6015Y, Lpa6011N, Lpa6012N, Lpa6013N, Lpa6014N, Lpa6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:53:44.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447450QB</udiDi>
    <basicUdiDi>B-447450QB</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent</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>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447450</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:20.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1947C</udiDi>
    <basicUdiDi>B-1947C</basicUdiDi>
    <tradeName>D-1947C</tradeName>
    <deviceName>Lipoprotein (a) Test Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:16:32.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102H40TSCZ2</udiDi>
    <basicUdiDi>B-102H40TSCZ2</basicUdiDi>
    <tradeName>Lipoprotein(a) (Lp(a)) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Lipoprotein(a) (Lp(a)) Assay Kit (Immunoturbidimetric 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>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102H40TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:58:10.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102H40T2R</udiDi>
    <basicUdiDi>B-102H40T2R</basicUdiDi>
    <tradeName>Lipoprotein(a) (Lp(a)) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Lipoprotein(a) (Lp(a)) Assay Kit (Immunoturbidimetric 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>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102H40T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:58:09.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102H160TSCH7</udiDi>
    <basicUdiDi>B-102H160TSCH7</basicUdiDi>
    <tradeName>Lipoprotein(a) (Lp(a)) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Lipoprotein(a) (Lp(a)) Assay Kit (Immunoturbidimetric 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>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102H160TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:58:07.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102H160TE3</udiDi>
    <basicUdiDi>B-102H160TE3</basicUdiDi>
    <tradeName>Lipoprotein(a) (Lp(a)) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Lipoprotein(a) (Lp(a)) Assay Kit (Immunoturbidimetric 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>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102H160T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:58:06.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972035</udiDi>
    <basicUdiDi>B-08053172972035</basicUdiDi>
    <tradeName>Lipoproteina (a)</tradeName>
    <deviceName>Lipoproteina (a)/Lipoprotein (a)</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6730</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:47:54.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350108630016</udiDi>
    <basicUdiDi>B-07350108630016</basicUdiDi>
    <tradeName>Mercodia Lp(a) ELISA</tradeName>
    <deviceName>Mercodia Lp(a) ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1106-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:16:59.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753471852</udiDi>
    <basicUdiDi>B-06976753471852</basicUdiDi>
    <tradeName>Lipoprotein(a) [Lp(a)] Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KL001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:57:15.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975225464354</udiDi>
    <basicUdiDi>B-06975225464354</basicUdiDi>
    <tradeName>06975225464354</tradeName>
    <deviceName>Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH030806C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:17.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975225464347</udiDi>
    <basicUdiDi>B-06975225464347</basicUdiDi>
    <tradeName>06975225464347</tradeName>
    <deviceName>Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH030806</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:16.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975225464330</udiDi>
    <basicUdiDi>B-06975225464330</basicUdiDi>
    <tradeName>06975225464330</tradeName>
    <deviceName>Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH030805C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:12.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975225464323</udiDi>
    <basicUdiDi>B-06975225464323</basicUdiDi>
    <tradeName>06975225464323</tradeName>
    <deviceName>Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH030805</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:11.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975225464316</udiDi>
    <basicUdiDi>B-06975225464316</basicUdiDi>
    <tradeName>06975225464316</tradeName>
    <deviceName>Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH030801C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:10.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975225464309</udiDi>
    <basicUdiDi>B-06975225464309</basicUdiDi>
    <tradeName>06975225464309</tradeName>
    <deviceName>Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH030801</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:10.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975225464293</udiDi>
    <basicUdiDi>B-06975225464293</basicUdiDi>
    <tradeName>06975225464293</tradeName>
    <deviceName>Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH030807C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:06.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975225464286</udiDi>
    <basicUdiDi>B-06975225464286</basicUdiDi>
    <tradeName>06975225464286</tradeName>
    <deviceName>Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH030807</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:05.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975225464279</udiDi>
    <basicUdiDi>B-06975225464279</basicUdiDi>
    <tradeName>06975225464279</tradeName>
    <deviceName>Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH030803C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:04.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975225464262</udiDi>
    <basicUdiDi>B-06975225464262</basicUdiDi>
    <tradeName>06975225464262</tradeName>
    <deviceName>Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH030803</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:03.644Z</lastUpdated>
  </row>
</eudamedExport>