<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942359535380</udiDi>
    <basicUdiDi>697015090000194HQ</basicUdiDi>
    <tradeName>AST-GP01</tradeName>
    <deviceName>AST-GP01</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>W0104080108</emdnCode>
    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME1102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:44.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359535373</udiDi>
    <basicUdiDi>697015090000194HQ</basicUdiDi>
    <tradeName>AST-GP01</tradeName>
    <deviceName>AST-GP01</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>W0104080108</emdnCode>
    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME1101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:42.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359535366</udiDi>
    <basicUdiDi>697015090000193HN</basicUdiDi>
    <tradeName>AST-NF01</tradeName>
    <deviceName>AST-NF01</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>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME1003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:38.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359535359</udiDi>
    <basicUdiDi>697015090000193HN</basicUdiDi>
    <tradeName>AST-NF01</tradeName>
    <deviceName>AST-NF01</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>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME1002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:36.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359531658</udiDi>
    <basicUdiDi>697015090000170HA</basicUdiDi>
    <tradeName>Sputum Processing Reagent</tradeName>
    <deviceName>Sputum Processing Reagent</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>W0104010899</emdnCode>
    <emdnDescription>BUFFERS, STAINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS030103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:35.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359531641</udiDi>
    <basicUdiDi>697015090000170HA</basicUdiDi>
    <tradeName>Sputum Processing Reagent</tradeName>
    <deviceName>Sputum Processing Reagent</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>W0104010899</emdnCode>
    <emdnDescription>BUFFERS, STAINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS030102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:32.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359531634</udiDi>
    <basicUdiDi>697015090000170HA</basicUdiDi>
    <tradeName>Sputum Processing Reagent</tradeName>
    <deviceName>Sputum Processing Reagent</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>W0104010899</emdnCode>
    <emdnDescription>BUFFERS, STAINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS030101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:27.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359525800</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>MC0309</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:25.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359525794</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>MC0308</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:24.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359525787</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>MC0307</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:21.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359525572</udiDi>
    <basicUdiDi>697015090000133H4</basicUdiDi>
    <tradeName>S100 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>W0102039012</emdnCode>
    <emdnDescription>PROTEIN S-100 B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMB2310</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:18.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359525473</udiDi>
    <basicUdiDi>697015090000132H2</basicUdiDi>
    <tradeName>HER-2/neu 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>W0102030301</emdnCode>
    <emdnDescription>HER-2/NEU</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMB2210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:15.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359525374</udiDi>
    <basicUdiDi>697015090000137HC</basicUdiDi>
    <tradeName>β-CTX CLIA Microparticles</tradeName>
    <deviceName>β-CTX 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060304</emdnCode>
    <emdnDescription>CROSS-LINKED C-TELOPEPTIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMS0810</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:14.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359525275</udiDi>
    <basicUdiDi>697015090000139HG</basicUdiDi>
    <tradeName>PINP CLIA Microparticles</tradeName>
    <deviceName>PINP 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060317</emdnCode>
    <emdnDescription>PROCOLLAGEN TYPE I N TERMINAL PROPEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMS0710</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:10.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359522670</udiDi>
    <basicUdiDi>697015090000130GW</basicUdiDi>
    <tradeName>Thyroid Speciality Control</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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZK0501L306</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:07.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359522663</udiDi>
    <basicUdiDi>697015090000130GW</basicUdiDi>
    <tradeName>Thyroid Speciality Control</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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZK0501L206</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:05.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359522656</udiDi>
    <basicUdiDi>697015090000130GW</basicUdiDi>
    <tradeName>Thyroid Speciality Control</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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZK0501L106</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:03.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359521857</udiDi>
    <basicUdiDi>697015090000193HN</basicUdiDi>
    <tradeName>AST-NF01</tradeName>
    <deviceName>AST-NF01</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>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME1001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:54:01.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359521840</udiDi>
    <basicUdiDi>697015090000192HL</basicUdiDi>
    <tradeName>AST-EB01</tradeName>
    <deviceName>AST-EB01</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>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME0903</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:53:56.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359521833</udiDi>
    <basicUdiDi>697015090000192HL</basicUdiDi>
    <tradeName>AST-EB01</tradeName>
    <deviceName>AST-EB01</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>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME0902</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:53:54.190Z</lastUpdated>
  </row>
</eudamedExport>