<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DT01797W</udiDi>
    <basicUdiDi>B-DT01797W</basicUdiDi>
    <tradeName>MAU</tradeName>
    <deviceName>MAU</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0179</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:17:38.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT00897U</udiDi>
    <basicUdiDi>B-DT00897U</basicUdiDi>
    <tradeName>Unicorn-MAU</tradeName>
    <deviceName>Unicorn-MAU</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0089</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:16:09.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT002572</udiDi>
    <basicUdiDi>B-DT002572</basicUdiDi>
    <tradeName>Unicorn-MAU</tradeName>
    <deviceName>Unicorn-MAU</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:14:45.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CYS-C601K6</udiDi>
    <basicUdiDi>B-CYS-C601K6</basicUdiDi>
    <tradeName>Cystatin C Reagent Kit</tradeName>
    <deviceName>Cystatin C 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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYS-C6011Y, CYS-C6012Y, CYS-C6013Y, CYS-C6014Y, CYS-C6015Y, CYS-C6011N, CYS-C6012N, CYS-C6013N, CYS-C6014N, CYS-C6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:39:37.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CQ5771023F</udiDi>
    <basicUdiDi>B-CQ5771023F</basicUdiDi>
    <tradeName>D-CQ5771023F</tradeName>
    <deviceName>HISCL β-Amyloid 1-42 Assay kit</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CQ577102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:20:00.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C4601MG</udiDi>
    <basicUdiDi>B-C4601MG</basicUdiDi>
    <tradeName>Complement 4 Reagent Kit</tradeName>
    <deviceName>Complement 4 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>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C46011Y, C46011Y, C46011Y, C46011Y, C46011Y, C46011N, C46011N, C46011N, C46011N, C46011N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:01.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C3601M9</udiDi>
    <basicUdiDi>B-C3601M9</basicUdiDi>
    <tradeName>Complement 3 Reagent Kit</tradeName>
    <deviceName>Complement 3 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>W0102010203</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C3/C3C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C36011Y, C36011Y, C36011Y, C36011Y, C36011Y, C36011N, C36011N, C36011N, C36011N, C36011N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:35.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BV4191423U</udiDi>
    <basicUdiDi>B-BV4191423U</basicUdiDi>
    <tradeName>D-BV4191423U</tradeName>
    <deviceName>HISCL β-Amyloid 1-40 Assay kit</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BV419142</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:30:04.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL170013UX</udiDi>
    <basicUdiDi>B-BL170013UX</basicUdiDi>
    <tradeName>D-BL170013UX</tradeName>
    <deviceName>HISCL β-Amyloid 1-40 Calibrator</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL170013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:02.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AntiSpark100nAbAssay8B</udiDi>
    <basicUdiDi>B-AntiSpark100nAbAssay8B</basicUdiDi>
    <tradeName>nAbCyte Anti-AAVRh74var HB-FE Assay</tradeName>
    <deviceName>nAbCyte Anti-AAVRh74var HB-FE Assay</deviceName>
    <manufacturerName>Laboratory Corporation of America Holdings</manufacturerName>
    <manufacturerSrn>US-MF-000017722</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010199</emdnCode>
    <emdnDescription>IMMUNOGLOBULINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Anti-Spark 100 nAb Assay</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:46:28.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Anti-AAV9nAbAssayNS</udiDi>
    <basicUdiDi>B-Anti-AAV9nAbAssayNS</basicUdiDi>
    <tradeName>Anti-AAv9 nAb</tradeName>
    <deviceName>Anti-AAV9 nAb Assay</deviceName>
    <manufacturerName>Laboratory Corporation of America Holdings</manufacturerName>
    <manufacturerSrn>US-MF-000017722</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010199</emdnCode>
    <emdnDescription>IMMUNOGLOBULINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Anti-AAV9 nAb</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:46:25.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Anti-AAV6nAbAssayLM</udiDi>
    <basicUdiDi>B-Anti-AAV6nAbAssayLM</basicUdiDi>
    <tradeName>Anti-AAV6 nAb Assay</tradeName>
    <deviceName>Anti-AAV6 nAb Assay</deviceName>
    <manufacturerName>Laboratory Corporation of America Holdings</manufacturerName>
    <manufacturerSrn>US-MF-000017722</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010199</emdnCode>
    <emdnDescription>IMMUNOGLOBULINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Anti-AAV6 nAb Assay</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:46:20.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AT130265</udiDi>
    <basicUdiDi>B-AT130265</basicUdiDi>
    <tradeName>D-AT130265</tradeName>
    <deviceName>a-1 Acid Glycoprotein 5+1</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019001</emdnCode>
    <emdnDescription>A1-ACID GLYCOPROTEIN (OROSOMUCOID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT1302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:44:55.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-APOE601WG</udiDi>
    <basicUdiDi>B-APOE601WG</basicUdiDi>
    <tradeName>Apolipoprotein E Reagent Kit</tradeName>
    <deviceName>Apolipoprotein E 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>W0102010404</emdnCode>
    <emdnDescription>APOLIPOPROTEIN E SUB-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APOE6011Y, APOE6012Y, APOE6013Y, APOE6014Y, APOE6015Y, APOE6011N, APOE6012N, APOE6013N, APOE6014N, APOE6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:36:16.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-APOC2601FA</udiDi>
    <basicUdiDi>B-APOC2601FA</basicUdiDi>
    <tradeName>Apolipoprotein C2 Reagent Kit</tradeName>
    <deviceName>Apolipoprotein C2 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>W0102010499</emdnCode>
    <emdnDescription>LIPOPROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APOC26011Y, APOC26012Y, APOC26013Y, APOC26014Y, APOC26015Y, APOC26011N, APOC26012N, APOC26013N, APOC26014N, APOC26015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:36:15.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-APOB601VT</udiDi>
    <basicUdiDi>B-APOB601VT</basicUdiDi>
    <tradeName>Apolipoprotein B Reagent Kit</tradeName>
    <deviceName>Apolipoprotein B 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>W0102010403</emdnCode>
    <emdnDescription>APOLIPOPROTEIN B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APOB6011Y, APOB6012Y, APOB6013Y, APOB6014Y, APOB6015Y, APOB6011N, APOB6012N, APOB6013N, APOB6014N, APOB6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:36:14.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-APOA2601EL</udiDi>
    <basicUdiDi>B-APOA2601EL</basicUdiDi>
    <tradeName>Apolipoprotein A2 Reagent Kit</tradeName>
    <deviceName>Apolipoprotein A2 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>W0102010402</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APOA26011Y, APOA26012Y, APOA26013Y, APOA26014Y, APOA26015Y, APOA26011N, APOA26012N, APOA26013N, APOA26014N, APOA26015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:36:10.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-APOA1601ED</udiDi>
    <basicUdiDi>B-APOA1601ED</basicUdiDi>
    <tradeName>Apolipoprotein A1 Reagent Kit</tradeName>
    <deviceName>Apolipoprotein A1 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>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APOA16011Y, APOA16012Y, APOA16013Y, APOA16014Y, APOA16015Y, APOA16011N, APOA16012N, APOA16013N, APOA16014N, APOA16015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:36:09.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ADA6014B</udiDi>
    <basicUdiDi>B-ADA6014B</basicUdiDi>
    <tradeName>Adenosine Deaminase Reagent Kit</tradeName>
    <deviceName>Adenosine Deaminase 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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADA6011Y, ADA6012Y, ADA6013Y, ADA6014Y, ADA6015Y, ADA6011N, ADA6012N, ADA6013N, ADA6014N, ADA6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:40.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AA1002X2</udiDi>
    <basicUdiDi>B-AA1002X2</basicUdiDi>
    <tradeName>D-AA1002X2</tradeName>
    <deviceName>a-1 Acid Glycoprotein 5+1</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019001</emdnCode>
    <emdnDescription>A1-ACID GLYCOPROTEIN (OROSOMUCOID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA1002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:16:49.881Z</lastUpdated>
  </row>
</eudamedExport>