<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-0320517904XF</udiDi>
    <basicUdiDi>B-0320517904XF</basicUdiDi>
    <tradeName>PR3 IgG (eCLIA)</tradeName>
    <deviceName>PR3 IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517904</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:17.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517903XD</udiDi>
    <basicUdiDi>B-0320517903XD</basicUdiDi>
    <tradeName>PR3 IgG (eCLIA)</tradeName>
    <deviceName>PR3 IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517903</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:15.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517902XB</udiDi>
    <basicUdiDi>B-0320517902XB</basicUdiDi>
    <tradeName>PR3 IgG (eCLIA)</tradeName>
    <deviceName>PR3 IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517902</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:14.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517901X9</udiDi>
    <basicUdiDi>B-0320517901X9</basicUdiDi>
    <tradeName>PR3 IgG (eCLIA)</tradeName>
    <deviceName>PR3 IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:13.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517804XA</udiDi>
    <basicUdiDi>B-0320517804XA</basicUdiDi>
    <tradeName>MPO IgG (eCLIA)</tradeName>
    <deviceName>MPO IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517804</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:10.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517803X8</udiDi>
    <basicUdiDi>B-0320517803X8</basicUdiDi>
    <tradeName>MPO IgG (eCLIA)</tradeName>
    <deviceName>MPO IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517803</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:09.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517802X6</udiDi>
    <basicUdiDi>B-0320517802X6</basicUdiDi>
    <tradeName>MPO IgG (eCLIA)</tradeName>
    <deviceName>MPO IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:08.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517801X4</udiDi>
    <basicUdiDi>B-0320517801X4</basicUdiDi>
    <tradeName>MPO IgG (eCLIA)</tradeName>
    <deviceName>MPO IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:06.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517701WX</udiDi>
    <basicUdiDi>B-0320517701WX</basicUdiDi>
    <tradeName>Chagas Controls</tradeName>
    <deviceName>Chagas Controls</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:04.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517604WY</udiDi>
    <basicUdiDi>B-0320517604WY</basicUdiDi>
    <tradeName>Chagas (eCLIA)</tradeName>
    <deviceName>Chagas (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517604</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:02.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517603WW</udiDi>
    <basicUdiDi>B-0320517603WW</basicUdiDi>
    <tradeName>Chagas (eCLIA)</tradeName>
    <deviceName>Chagas (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517603</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:01.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517602WU</udiDi>
    <basicUdiDi>B-0320517602WU</basicUdiDi>
    <tradeName>Chagas (eCLIA)</tradeName>
    <deviceName>Chagas (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:00.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517601WS</udiDi>
    <basicUdiDi>B-0320517601WS</basicUdiDi>
    <tradeName>Chagas (eCLIA)</tradeName>
    <deviceName>Chagas (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:57.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517503WR</udiDi>
    <basicUdiDi>B-0320517503WR</basicUdiDi>
    <tradeName>EBV VCA IgG (eCLIA)</tradeName>
    <deviceName>EBV VCA IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517503</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:56.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517502WP</udiDi>
    <basicUdiDi>B-0320517502WP</basicUdiDi>
    <tradeName>EBV VCA IgG (eCLIA)</tradeName>
    <deviceName>EBV VCA IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:55.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517504WT</udiDi>
    <basicUdiDi>B-0320517504WT</basicUdiDi>
    <tradeName>EBV VCA IgG (eCLIA)</tradeName>
    <deviceName>EBV VCA IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517504</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:53.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517501WM</udiDi>
    <basicUdiDi>B-0320517501WM</basicUdiDi>
    <tradeName>EBV VCA IgG (eCLIA)</tradeName>
    <deviceName>EBV VCA IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:40.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517404WN</udiDi>
    <basicUdiDi>B-0320517404WN</basicUdiDi>
    <tradeName>EBV IgM (eCLIA)</tradeName>
    <deviceName>EBV IgM (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040103</emdnCode>
    <emdnDescription>EBV IGM - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517404</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:36.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517403WL</udiDi>
    <basicUdiDi>B-0320517403WL</basicUdiDi>
    <tradeName>EBV IgM (eCLIA)</tradeName>
    <deviceName>EBV IgM (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040103</emdnCode>
    <emdnDescription>EBV IGM - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517403</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:35.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517402WJ</udiDi>
    <basicUdiDi>B-0320517402WJ</basicUdiDi>
    <tradeName>EBV IgM (eCLIA)</tradeName>
    <deviceName>EBV IgM (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040103</emdnCode>
    <emdnDescription>EBV IGM - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:34.607Z</lastUpdated>
  </row>
</eudamedExport>