<?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>06942359545488</udiDi>
    <basicUdiDi>697015090000313H8</basicUdiDi>
    <tradeName>Anti-PR3 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>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ1505</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:03:18.022Z</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>06942359545464</udiDi>
    <basicUdiDi>697015090000313H8</basicUdiDi>
    <tradeName>Anti-PR3 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>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ1503</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:50:03.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719236</udiDi>
    <basicUdiDi>692591270092HG</basicUdiDi>
    <tradeName>iFlash-PR3 IgG</tradeName>
    <deviceName>iFlash-PR3 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>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89016G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:07.477Z</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>05425023681350</udiDi>
    <basicUdiDi>542502368BDDANCA4F</basicUdiDi>
    <tradeName>BlueDiverDot ANCA+GBM IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100401</emdnCode>
    <emdnDescription>ANCA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANCAGDIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:38.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680353</udiDi>
    <basicUdiDi>542502368BDANCAYR</basicUdiDi>
    <tradeName>BlueDot ANCA+GBM IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100401</emdnCode>
    <emdnDescription>ANCA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANCAGD-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:18.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147157050</udiDi>
    <basicUdiDi>B-86060147157050</basicUdiDi>
    <tradeName>Anti-PR3 hs</tradeName>
    <deviceName>Anti-PR3 hs</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>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N262A24PR3</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:18:56.620Z</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>86060147154776</udiDi>
    <basicUdiDi>B-86060147154776</basicUdiDi>
    <tradeName>ANCA-Pro</tradeName>
    <deviceName>ANCA-Pro</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>W0102100401</emdnCode>
    <emdnDescription>ANCA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N261A24ACA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:18:51.019Z</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>D-A060PLX4</udiDi>
    <basicUdiDi>B-A060PLX4</basicUdiDi>
    <tradeName>Anti-Neutrophil Cytoplasmic Antibody (Formalin Fixed)</tradeName>
    <deviceName>Anti-Neutrophil Cytoplasmic Antibody (Formalin Fixed)</deviceName>
    <manufacturerName>ZEUS Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000026845</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100401</emdnCode>
    <emdnDescription>ANCA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A060PL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:15:17.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A060LMJ</udiDi>
    <basicUdiDi>B-A060LMJ</basicUdiDi>
    <tradeName>Anti-Neutrophil Cytoplasmic Antibody (Ethanol Fixed)</tradeName>
    <deviceName>Anti-Neutrophil Cytoplasmic Antibody (Ethanol Fixed)</deviceName>
    <manufacturerName>ZEUS Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000026845</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100401</emdnCode>
    <emdnDescription>ANCA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A060L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:15:17.356Z</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>06925912723912</udiDi>
    <basicUdiDi>692591270092HG</basicUdiDi>
    <tradeName>iFlash-PR3 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>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89016G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:13.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287148985</udiDi>
    <basicUdiDi>B-08435287148985</basicUdiDi>
    <tradeName>08435287148985</tradeName>
    <deviceName>ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100499</emdnCode>
    <emdnDescription>VASCULITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44898</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:51:41.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287148787</udiDi>
    <basicUdiDi>B-08435287148787</basicUdiDi>
    <tradeName>08435287148787</tradeName>
    <deviceName>ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100499</emdnCode>
    <emdnDescription>VASCULITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44878</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:51:33.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287148527</udiDi>
    <basicUdiDi>B-08435287148527</basicUdiDi>
    <tradeName>08435287148527</tradeName>
    <deviceName>ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100499</emdnCode>
    <emdnDescription>VASCULITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44852</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:50:53.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287148510</udiDi>
    <basicUdiDi>B-08435287148510</basicUdiDi>
    <tradeName>08435287148510</tradeName>
    <deviceName>ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100499</emdnCode>
    <emdnDescription>VASCULITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44851</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:50:52.232Z</lastUpdated>
  </row>
</eudamedExport>