<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05425025460489</udiDi>
    <basicUdiDi>B-05425025460489</basicUdiDi>
    <tradeName>05425025460489</tradeName>
    <deviceName>NEONATAL TSH Screening ELISA</deviceName>
    <manufacturerName>Zentech s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000001650</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020403</emdnCode>
    <emdnDescription>NEONATAL THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-GP-576</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:46:19.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025460472</udiDi>
    <basicUdiDi>B-05425025460472</basicUdiDi>
    <tradeName>05425025460472</tradeName>
    <deviceName>NEONATAL TSH Screening ELISA</deviceName>
    <manufacturerName>Zentech s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000001650</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020403</emdnCode>
    <emdnDescription>NEONATAL THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-GP-192</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:46:18.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025460229</udiDi>
    <basicUdiDi>B-05425025460229</basicUdiDi>
    <tradeName>05425025460229</tradeName>
    <deviceName>NEONATAL PAP Screening ELISA</deviceName>
    <manufacturerName>Zentech s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000001650</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-LC-192</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:46:16.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025460090</udiDi>
    <basicUdiDi>B-05425025460090</basicUdiDi>
    <tradeName>05425025460090</tradeName>
    <deviceName>NEONATAL IRT Screening ELISA</deviceName>
    <manufacturerName>Zentech s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000001650</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-KR-1920</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:46:14.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025460083</udiDi>
    <basicUdiDi>B-05425025460083</basicUdiDi>
    <tradeName>05425025460083</tradeName>
    <deviceName>NEONATAL IRT Screening ELISA</deviceName>
    <manufacturerName>Zentech s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000001650</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-KR-576</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:46:13.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025460076</udiDi>
    <basicUdiDi>B-05425025460076</basicUdiDi>
    <tradeName>05425025460076</tradeName>
    <deviceName>NEONATAL IRT Screening ELISA</deviceName>
    <manufacturerName>Zentech s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000001650</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-KR-192</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:46:11.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025460014</udiDi>
    <basicUdiDi>B-05425025460014</basicUdiDi>
    <tradeName>05425025460014</tradeName>
    <deviceName>Targeted MS/MS Hemo</deviceName>
    <manufacturerName>Zentech s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000001650</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J-LS-480PartB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:46:09.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025460007</udiDi>
    <basicUdiDi>B-05425025460007</basicUdiDi>
    <tradeName>05425025460007</tradeName>
    <deviceName>Targeted MS/MS Hemo</deviceName>
    <manufacturerName>Zentech s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000001650</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J-LS-480PartA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:46:07.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681770</udiDi>
    <basicUdiDi>B-05425023681770</basicUdiDi>
    <tradeName>Myositis Profile 12 Ag OJ Dot for BDI</tradeName>
    <deviceName>BlueDiver Dot Myositis</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD MYOSO12ADBD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:46:07.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681381</udiDi>
    <basicUdiDi>B-05425023681381</basicUdiDi>
    <tradeName>BlueDiver Dot Milk Intolerance IgG</tradeName>
    <deviceName>BlueDiver Dot Milk Intolerance</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSDIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:46:04.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680384</udiDi>
    <basicUdiDi>B-05425023680384</basicUdiDi>
    <tradeName>BlueDot Milk Intolerance IgG</tradeName>
    <deviceName>BlueDot Milk Intolerance IgG</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSD-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:46:02.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681374</udiDi>
    <basicUdiDi>B-05425023681374</basicUdiDi>
    <tradeName>BlueDiver Dot ASCA IgG + IgA</tradeName>
    <deviceName>BlueDiver Dot Crohn</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109018</emdnCode>
    <emdnDescription>SACCHAROMYCES CEREVISIAE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASCCDIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:45:59.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680834</udiDi>
    <basicUdiDi>B-05425023680834</basicUdiDi>
    <tradeName>Myositis Profile 12 Ag OJ Dot</tradeName>
    <deviceName>BlueDot Myositis</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD MYOSO12AD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:45:58.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680377</udiDi>
    <basicUdiDi>B-05425023680377</basicUdiDi>
    <tradeName>BlueDot ASCA IgG + IgA</tradeName>
    <deviceName>BlueDot ASCA IgG + IgA</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109018</emdnCode>
    <emdnDescription>SACCHAROMYCES CEREVISIAE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASCCD-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:45:57.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680339</udiDi>
    <basicUdiDi>B-05425023680339</basicUdiDi>
    <tradeName>BlueDot ANA12 Screen IgG</tradeName>
    <deviceName>BlueDot ANA12 Screen IgG</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANA12SD-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:45:41.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680209</udiDi>
    <basicUdiDi>B-05425023680209</basicUdiDi>
    <tradeName>BlueWell Deamidated Gliadin IgG ELISA</tradeName>
    <deviceName>BlueWell Celiac</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100602</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DGLG02-96</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:45:40.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680193</udiDi>
    <basicUdiDi>B-05425023680193</basicUdiDi>
    <tradeName>BlueWell Deamidated Gliadin IgA ELISA</tradeName>
    <deviceName>BlueWell Celiac</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100602</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DGLA02-96</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:45:39.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680162</udiDi>
    <basicUdiDi>B-05425023680162</basicUdiDi>
    <tradeName>BlueWell Transglutaminase IgG ELISA</tradeName>
    <deviceName>BlueWell Celiac</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100602</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TTG02-96</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:45:35.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680148</udiDi>
    <basicUdiDi>B-05425023680148</basicUdiDi>
    <tradeName>BlueWell Transglutaminase IgA ELISA</tradeName>
    <deviceName>BlueWell Celiac</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100602</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TTA02-96</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:45:34.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680117</udiDi>
    <basicUdiDi>B-05425023680117</basicUdiDi>
    <tradeName>BlueWell Intrinsic Factor IgG</tradeName>
    <deviceName>BlueWell Gastritis</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF01-96</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:45:34.063Z</lastUpdated>
  </row>
</eudamedExport>