<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942359545587</udiDi>
    <basicUdiDi>697015090000314HA</basicUdiDi>
    <tradeName>Anti-MPO IgG CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ1605</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:03:19.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359545563</udiDi>
    <basicUdiDi>697015090000314HA</basicUdiDi>
    <tradeName>Anti-MPO IgG CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ1603</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:50:04.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912717065</udiDi>
    <basicUdiDi>692591270090HC</basicUdiDi>
    <tradeName>iFlash-MPO IgG</tradeName>
    <deviceName>iFlash-MPO IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89001G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:56.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147156510</udiDi>
    <basicUdiDi>B-86060147156510</basicUdiDi>
    <tradeName>Anti-MPO</tradeName>
    <deviceName>Anti-MPO</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>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N263A24MPO</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:18:53.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891324599</udiDi>
    <basicUdiDi>803389132CHORUSMPO200B4</basicUdiDi>
    <tradeName>CHORUS MPO</tradeName>
    <deviceName>CHORUS MPO</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86120</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:48:05.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912723790</udiDi>
    <basicUdiDi>692591270090HC</basicUdiDi>
    <tradeName>iFlash-MPO IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89001G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:13.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950627685</udiDi>
    <basicUdiDi>B-08426950627685</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® MPO Reagents</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701130</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:54.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950544197</udiDi>
    <basicUdiDi>B-08426950544197</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® MPO Reagents</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701133</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:19:15.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891324605</udiDi>
    <basicUdiDi>803389132CHORUSMPO200B4</basicUdiDi>
    <tradeName>CHORUS MPO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86120/12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T12:44:05.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225626</udiDi>
    <basicUdiDi>B-06975424225626</basicUdiDi>
    <tradeName>Anti-MPO Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-MPO Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234501C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:43:18.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223929</udiDi>
    <basicUdiDi>B-06975424223929</basicUdiDi>
    <tradeName>06975424223929</tradeName>
    <deviceName>Anti-MPO Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234506</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:30.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424221840</udiDi>
    <basicUdiDi>B-06975424221840</basicUdiDi>
    <tradeName>Anti-MPO Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-MPO Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:37:04.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070769314</udiDi>
    <basicUdiDi>B-06975070769314</basicUdiDi>
    <tradeName>Sharay Anti-MPO IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-MPO IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000722</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:50:27.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070761011</udiDi>
    <basicUdiDi>B-06975070761011</basicUdiDi>
    <tradeName>Sharay Anti-MPO IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-MPO IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18103001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:33:15.080Z</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>08034049110927</udiDi>
    <basicUdiDi>8034049110927VQ</basicUdiDi>
    <tradeName>08034049110927</tradeName>
    <deviceName>Anti MPO (p-ANCA)</deviceName>
    <manufacturerName>Dia.Metra Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027206</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DKO092</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:24:57.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891323530</udiDi>
    <basicUdiDi>803389132CHORUSMPO00BD</basicUdiDi>
    <tradeName>CHORUS MPO</tradeName>
    <deviceName>CHORUS MPO</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86068</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:19:18.076Z</lastUpdated>
  </row>
</eudamedExport>