<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942359545389</udiDi>
    <basicUdiDi>697015090000312H6</basicUdiDi>
    <tradeName>Anti-Ribosomal P 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>W0102100118</emdnCode>
    <emdnDescription>RIBOSOMAL PHOSPHOPROTEIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ2205</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:03:15.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359545280</udiDi>
    <basicUdiDi>697015090000311H4</basicUdiDi>
    <tradeName>Anti-nRNP/Sm 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>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ2105</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:03:14.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359544986</udiDi>
    <basicUdiDi>697015090000308HF</basicUdiDi>
    <tradeName>Anti-Scl-70 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>W0102100110</emdnCode>
    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ1805</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:03:13.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359545181</udiDi>
    <basicUdiDi>697015090000310H2</basicUdiDi>
    <tradeName>Anti-Sm 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>W0102100111</emdnCode>
    <emdnDescription>SM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ2005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:03:11.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359544887</udiDi>
    <basicUdiDi>697015090000307HD</basicUdiDi>
    <tradeName>Anti-SS-B 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>W0102100113</emdnCode>
    <emdnDescription>SS-B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ0905</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:03:09.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359544788</udiDi>
    <basicUdiDi>697015090000306HB</basicUdiDi>
    <tradeName>Anti-Ro-52 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>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ0805</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:03:09.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359544689</udiDi>
    <basicUdiDi>697015090000305H9</basicUdiDi>
    <tradeName>Anti-SS-A/Ro 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>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ0705</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:03:07.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359545365</udiDi>
    <basicUdiDi>697015090000312H6</basicUdiDi>
    <tradeName>Anti-Ribosomal P 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>W0102100118</emdnCode>
    <emdnDescription>RIBOSOMAL PHOSPHOPROTEIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ2203</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:50:03.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359545266</udiDi>
    <basicUdiDi>697015090000311H4</basicUdiDi>
    <tradeName>Anti-nRNP/Sm 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>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ2103</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:50:03.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359545167</udiDi>
    <basicUdiDi>697015090000310H2</basicUdiDi>
    <tradeName>Anti-Sm 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>W0102100111</emdnCode>
    <emdnDescription>SM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ2003</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:49:58.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359545068</udiDi>
    <basicUdiDi>697015090000309HH</basicUdiDi>
    <tradeName>Anti-Jo-1 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>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ1903</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:49:57.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359544962</udiDi>
    <basicUdiDi>697015090000308HF</basicUdiDi>
    <tradeName>Anti-Scl-70 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>W0102100110</emdnCode>
    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ1803</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:49:53.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359544863</udiDi>
    <basicUdiDi>697015090000307HD</basicUdiDi>
    <tradeName>Anti-SS-B 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>W0102100113</emdnCode>
    <emdnDescription>SS-B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ0903</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:49:52.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359544764</udiDi>
    <basicUdiDi>697015090000306HB</basicUdiDi>
    <tradeName>Anti-Ro-52 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>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ0803</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:49:52.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359544665</udiDi>
    <basicUdiDi>697015090000305H9</basicUdiDi>
    <tradeName>Anti-SS-A/Ro 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>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ0703</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:49:51.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359514453</udiDi>
    <basicUdiDi>697015090000326HH</basicUdiDi>
    <tradeName>ANA 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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ3301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:47:51.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359514422</udiDi>
    <basicUdiDi>697015090000325HF</basicUdiDi>
    <tradeName>Anti-dsDNA 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>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ2310</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:47:51.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912720348</udiDi>
    <basicUdiDi>692591270251HC</basicUdiDi>
    <tradeName>iFlash-Ro-52 IgG</tradeName>
    <deviceName>iFlash-Ro-52 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>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86082G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:06.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912720331</udiDi>
    <basicUdiDi>692591270259HU</basicUdiDi>
    <tradeName>iFlash-PM-Scl IgG</tradeName>
    <deviceName>iFlash-PM-Scl 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>W0102100109</emdnCode>
    <emdnDescription>PM-SCL - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86081G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:05.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912720324</udiDi>
    <basicUdiDi>692591270250HA</basicUdiDi>
    <tradeName>iFlash-Histones IgG</tradeName>
    <deviceName>iFlash-Histones 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>W0102100107</emdnCode>
    <emdnDescription>HISTONES (H1, H2A, H3, H4,…HN)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86080G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:04.756Z</lastUpdated>
  </row>
</eudamedExport>