<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975577171702</udiDi>
    <basicUdiDi>697015090000043H2</basicUdiDi>
    <tradeName>PCT CLIA Microparticles</tradeName>
    <deviceName>PCT CLIA Microparticles</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMR0201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:15:12.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577171214</udiDi>
    <basicUdiDi>697015090000082HC</basicUdiDi>
    <tradeName>BNP 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMH0802</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:15:11.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577171009</udiDi>
    <basicUdiDi>697015090000073HB</basicUdiDi>
    <tradeName>C-Peptide CLIA Microparticles</tradeName>
    <deviceName>C-Peptide CLIA Microparticles</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMG0201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:15:10.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577170965</udiDi>
    <basicUdiDi>697015090000072H9</basicUdiDi>
    <tradeName>Insulin CLIA Microparticles</tradeName>
    <deviceName>Insulin CLIA Microparticles</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMG0101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:15:09.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909994</udiDi>
    <basicUdiDi>697015090000077HK</basicUdiDi>
    <tradeName>Aerobic Culture Bottle PF</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010504</emdnCode>
    <emdnDescription>BOTTLES FOR AUTOMATED BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC0303</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:34.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909987</udiDi>
    <basicUdiDi>697015090000076HH</basicUdiDi>
    <tradeName>Anaerobic Culture Bottle FN</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010504</emdnCode>
    <emdnDescription>BOTTLES FOR AUTOMATED BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC0302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:31.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909970</udiDi>
    <basicUdiDi>697015090000057HD</basicUdiDi>
    <tradeName>Aerobic Culture Bottle FA</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010504</emdnCode>
    <emdnDescription>BOTTLES FOR AUTOMATED BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC0301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:30.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909949</udiDi>
    <basicUdiDi>697015090000063H8</basicUdiDi>
    <tradeName>Mycobacterial Culture Bottle</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010603</emdnCode>
    <emdnDescription>AUTOMATED MYCOBACTERIA MEDIA (BOTTLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC0401</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:24.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909468</udiDi>
    <basicUdiDi>697015090000056HB</basicUdiDi>
    <tradeName>Mycoplasma TIES</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080207</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0206</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:23.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909444</udiDi>
    <basicUdiDi>697015090000055H9</basicUdiDi>
    <tradeName>Mycoplasma IES</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080207</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0205</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:22.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909437</udiDi>
    <basicUdiDi>697015090000054H7</basicUdiDi>
    <tradeName>Mycoplasma (UU-MH) Culture Broth</tradeName>
    <deviceName>Mycoplasma (UU-MH) Culture Broth</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080207</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0204</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:20.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909383</udiDi>
    <basicUdiDi>697015090000138HE</basicUdiDi>
    <tradeName>Aerobic culture bottle SA</tradeName>
    <deviceName>Aerobic culture bottle SA</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010501</emdnCode>
    <emdnDescription>BOTTLES FOR MANUAL BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC0304</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:13.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909376</udiDi>
    <basicUdiDi>697015090000148HH</basicUdiDi>
    <tradeName>Aerobic Culture Bottle SP</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010501</emdnCode>
    <emdnDescription>BOTTLES FOR MANUAL BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC0305</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:12.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909369</udiDi>
    <basicUdiDi>697015090000149HK</basicUdiDi>
    <tradeName>Anaerobic culture bottle SN</tradeName>
    <deviceName>Anaerobic culture bottle SN</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010501</emdnCode>
    <emdnDescription>BOTTLES FOR MANUAL BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC0306</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:11.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909345</udiDi>
    <basicUdiDi>697015090000079HP</basicUdiDi>
    <tradeName>Tumour Marker Control II</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZKM0301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:10.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909338</udiDi>
    <basicUdiDi>697015090000079HP</basicUdiDi>
    <tradeName>Tumour Marker Control II</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZKM0201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:02.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909321</udiDi>
    <basicUdiDi>697015090000079HP</basicUdiDi>
    <tradeName>Tumour Marker Control II</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZKM0101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:01.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909314</udiDi>
    <basicUdiDi>697015090000078HM</basicUdiDi>
    <tradeName>Endocrine Control II</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZKE0301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:00.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909307</udiDi>
    <basicUdiDi>697015090000078HM</basicUdiDi>
    <tradeName>Endocrine Control II</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZKE0201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:48:59.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150909291</udiDi>
    <basicUdiDi>697015090000078HM</basicUdiDi>
    <tradeName>Endocrine Control II</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZKE0101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:48:53.191Z</lastUpdated>
  </row>
</eudamedExport>