<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ECH01010604M</udiDi>
    <basicUdiDi>B-ECH01010604M</basicUdiDi>
    <tradeName>D-ECH01010604M</tradeName>
    <deviceName>Urinary Microalbumin (mAlb)</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>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:33:34.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01010074H</udiDi>
    <basicUdiDi>B-ECH01010074H</basicUdiDi>
    <tradeName>D-ECH01010074H</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:33:22.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT01917L</udiDi>
    <basicUdiDi>B-DT01917L</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>DT0191</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:12.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT01927N</udiDi>
    <basicUdiDi>B-DT01927N</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>DT0192</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:10.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT01807F</udiDi>
    <basicUdiDi>B-DT01807F</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>DT0180</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:17:40.081Z</lastUpdated>
  </row>
  <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-988413TR</udiDi>
    <basicUdiDi>B-988413TR</basicUdiDi>
    <tradeName>Haptoglobin Reagent (HPT 2 x 100)</tradeName>
    <deviceName>Haptoglobin Reagent (HPT 2 x 100)</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>W0102010302</emdnCode>
    <emdnDescription>HAPTOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>988413</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:59:10.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-90501HC</udiDi>
    <basicUdiDi>B-90501HC</basicUdiDi>
    <tradeName>D-90501HC</tradeName>
    <deviceName>Fecal Transferrin Rapid Test（Colloidal Gold)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:09.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313275168</udiDi>
    <basicUdiDi>B-86060313275168</basicUdiDi>
    <tradeName>Albumin</tradeName>
    <deviceName>Albumin</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1820ALB</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:59.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313273492</udiDi>
    <basicUdiDi>B-86060313273492</basicUdiDi>
    <tradeName>Lactoferrin</tradeName>
    <deviceName>Lactoferrin</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010304</emdnCode>
    <emdnDescription>LACTOFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1827LAC</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:52.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-80H50TSCSZ</udiDi>
    <basicUdiDi>B-80H50TSCSZ</basicUdiDi>
    <tradeName>Microalbumin (MALB) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Microalbumin (MALB) 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>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80H50TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:57.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-80H150TSC8Q</udiDi>
    <basicUdiDi>B-80H150TSC8Q</basicUdiDi>
    <tradeName>Microalbumin (MALB) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Microalbumin (MALB) 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>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80H150TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:52.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-475106QC</udiDi>
    <basicUdiDi>B-475106QC</basicUdiDi>
    <tradeName>Prealbumin Reagent (PAB 2 x 100)</tradeName>
    <deviceName>Prealbumin Reagent (PAB 2 x 100)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>475106</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:06:27.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-475100PY</udiDi>
    <basicUdiDi>B-475100PY</basicUdiDi>
    <tradeName>Microalbumin Reagent (MA 2 x 100)</tradeName>
    <deviceName>Microalbumin Reagent (MA 2 x 100)</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>W0102010399</emdnCode>
    <emdnDescription>TRANSPORT PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>475100</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:06:07.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-467942RT</udiDi>
    <basicUdiDi>B-467942RT</basicUdiDi>
    <tradeName>Transferrin Reagent (TRFN 2 x 150)</tradeName>
    <deviceName>Transferrin Reagent (TRFN 2 x 150)</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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467942</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:34.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447720QH</udiDi>
    <basicUdiDi>B-447720QH</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems CER Ceruloplasmin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems CER Ceruloplasmin 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>W0102010301</emdnCode>
    <emdnDescription>CERULOPLASMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447720</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:35.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447700QB</udiDi>
    <basicUdiDi>B-447700QB</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems TRU Urine Transferrin Reagent</tradeName>
    <deviceName>447700</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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447700</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:34.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447690QZ</udiDi>
    <basicUdiDi>B-447690QZ</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems MA Microalbumin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems MA Microalbumin 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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447690</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:30.099Z</lastUpdated>
  </row>
</eudamedExport>