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<eudamedExport entity="devices">
  <row>
    <udiDi>D-ECH05023076T</udiDi>
    <basicUdiDi>B-ECH05023076T</basicUdiDi>
    <tradeName>D-ECH05023076T</tradeName>
    <deviceName>Immunoglobulin A (IgA)</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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0502307</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:44:12.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05013076L</udiDi>
    <basicUdiDi>B-ECH05013076L</basicUdiDi>
    <tradeName>D-ECH05013076L</tradeName>
    <deviceName>Immunoglobulin A (IgA)</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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0501307</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:23.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01093076Q</udiDi>
    <basicUdiDi>B-ECH01093076Q</basicUdiDi>
    <tradeName>D-ECH01093076Q</tradeName>
    <deviceName>Immunoglobulin A (IgA)</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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0109307</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:32.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01053075U</udiDi>
    <basicUdiDi>B-ECH01053075U</basicUdiDi>
    <tradeName>D-ECH01053075U</tradeName>
    <deviceName>Immunoglobulin A (IgA)</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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105307</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:37:09.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01013074Y</udiDi>
    <basicUdiDi>B-ECH01013074Y</basicUdiDi>
    <tradeName>D-ECH01013074Y</tradeName>
    <deviceName>Immunoglobulin A (IgA)</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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101307</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:34:39.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313274932</udiDi>
    <basicUdiDi>B-86060313274932</basicUdiDi>
    <tradeName>sIgA</tradeName>
    <deviceName>sIgA</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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1822SIGA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:57.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-467920RH</udiDi>
    <basicUdiDi>B-467920RH</basicUdiDi>
    <tradeName>Immunoglobulin A Reagent (Ig-A 2 x 150)</tradeName>
    <deviceName>Immunoglobulin A Reagent (Ig-A 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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467920</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:29.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-446460Q7</udiDi>
    <basicUdiDi>B-446460Q7</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems IGA Immunoglobulin 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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>446460</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:02.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1246P</udiDi>
    <basicUdiDi>B-1246P</basicUdiDi>
    <tradeName>D-1246P</tradeName>
    <deviceName>Immunoglobulin A Kit (Immunoturbidimetric Assay)</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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:54:53.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-121H60TSC2G</udiDi>
    <basicUdiDi>B-121H60TSC2G</basicUdiDi>
    <tradeName>Immunoglobulin A (IgA) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Immunoglobulin A (IgA) 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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121H60TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:53:21.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-121H60T3J</udiDi>
    <basicUdiDi>B-121H60T3J</basicUdiDi>
    <tradeName>Immunoglobulin A (IgA) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Immunoglobulin A (IgA) 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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121H60T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:53:21.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-121H160TSCJ2</udiDi>
    <basicUdiDi>B-121H160TSCJ2</basicUdiDi>
    <tradeName>Immunoglobulin A (IgA) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Immunoglobulin A (IgA) 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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121H160TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:53:17.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-121H160TEQ</udiDi>
    <basicUdiDi>B-121H160TEQ</basicUdiDi>
    <tradeName>Immunoglobulin A (IgA) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Immunoglobulin A (IgA) 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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121H160T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:53:16.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287130829</udiDi>
    <basicUdiDi>B-08435287130829</basicUdiDi>
    <tradeName>08435287130829</tradeName>
    <deviceName>IMMUNOGLOBULIN A (IgA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13082</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:48:02.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287130775</udiDi>
    <basicUdiDi>B-08435287130775</basicUdiDi>
    <tradeName>08435287130775</tradeName>
    <deviceName>IMMUNOGLOBULIN A (IgA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31077</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:47:56.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287110821</udiDi>
    <basicUdiDi>B-08435287110821</basicUdiDi>
    <tradeName>08435287110821</tradeName>
    <deviceName>IMMUNOGLOBULIN A (IgA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31082</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:45:26.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287110715</udiDi>
    <basicUdiDi>B-08435287110715</basicUdiDi>
    <tradeName>08435287110715</tradeName>
    <deviceName>IMMUNOGLOBULIN A (IgA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31071</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:43:29.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034049110781</udiDi>
    <basicUdiDi>B-08034049110781</basicUdiDi>
    <tradeName>08034049110781</tradeName>
    <deviceName>IgA Saliva ELISA</deviceName>
    <manufacturerName>Dia.Metra Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027206</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DKO078</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:01:52.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975225462992</udiDi>
    <basicUdiDi>B-06975225462992</basicUdiDi>
    <tradeName>06975225462992</tradeName>
    <deviceName>Immunoglobulin A Assay Kit (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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090311</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:18:49.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975225462985</udiDi>
    <basicUdiDi>B-06975225462985</basicUdiDi>
    <tradeName>06975225462985</tradeName>
    <deviceName>Immunoglobulin A Assay Kit (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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:18:33.592Z</lastUpdated>
  </row>
</eudamedExport>