<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060169694071</udiDi>
    <basicUdiDi>B-05060169694071</basicUdiDi>
    <tradeName>IDS CCP Control Set</tradeName>
    <deviceName>IDS CCP Control Set</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1230</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:00:15.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169694064</udiDi>
    <basicUdiDi>B-05060169694064</basicUdiDi>
    <tradeName>IDS ANCA/GBM Control Set</tradeName>
    <deviceName>IDS ANCA/GBM Control Set</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1730</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:00:14.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169694057</udiDi>
    <basicUdiDi>B-05060169694057</basicUdiDi>
    <tradeName>IDS Anti-TPO</tradeName>
    <deviceName>IDS Anti-TPO</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1902</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:00:10.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169694040</udiDi>
    <basicUdiDi>B-05060169694040</basicUdiDi>
    <tradeName>IDS Anti-TG</tradeName>
    <deviceName>IDS Anti-TG</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1901</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:00:08.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169694033</udiDi>
    <basicUdiDi>B-05060169694033</basicUdiDi>
    <tradeName>IDS AMA (M2)</tradeName>
    <deviceName>IDS AMA (M2)</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100501</emdnCode>
    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1801</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:00:07.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169694026</udiDi>
    <basicUdiDi>B-05060169694026</basicUdiDi>
    <tradeName>IDS LKM-1</tradeName>
    <deviceName>IDS LKM-1</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100701</emdnCode>
    <emdnDescription>HEPATITIS AUTOANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1802</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:00:07.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169694019</udiDi>
    <basicUdiDi>B-05060169694019</basicUdiDi>
    <tradeName>IDS CCP</tradeName>
    <deviceName>IDS CCP</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1201</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:00:02.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169694002</udiDi>
    <basicUdiDi>B-05060169694002</basicUdiDi>
    <tradeName>IDS GBM</tradeName>
    <deviceName>IDS GBM</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1703</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:00:01.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169693982</udiDi>
    <basicUdiDi>B-05060169693982</basicUdiDi>
    <tradeName>IDS MPO</tradeName>
    <deviceName>IDS MPO</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1701</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:00:00.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169693890</udiDi>
    <basicUdiDi>B-05060169693890</basicUdiDi>
    <tradeName>IDS ANA Screen Control Set</tradeName>
    <deviceName>IDS ANA Screen Control Set</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1030</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:59:59.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169693869</udiDi>
    <basicUdiDi>B-05060169693869</basicUdiDi>
    <tradeName>IDS Jo-1</tradeName>
    <deviceName>IDS Jo-1</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100110</emdnCode>
    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1109</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:59:42.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169693852</udiDi>
    <basicUdiDi>B-05060169693852</basicUdiDi>
    <tradeName>IDS Scl-70</tradeName>
    <deviceName>IDS Scl-70</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100110</emdnCode>
    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1108</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:59:41.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169693845</udiDi>
    <basicUdiDi>B-05060169693845</basicUdiDi>
    <tradeName>IDS U1-snRNP</tradeName>
    <deviceName>IDS U1-snRNP</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100114</emdnCode>
    <emdnDescription>U1-SNRNP - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1107</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:59:40.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169693838</udiDi>
    <basicUdiDi>B-05060169693838</basicUdiDi>
    <tradeName>IDS Sm</tradeName>
    <deviceName>IDS Sm</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100111</emdnCode>
    <emdnDescription>SM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1106</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:59:39.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169693821</udiDi>
    <basicUdiDi>B-05060169693821</basicUdiDi>
    <tradeName>IDS SS-B/La</tradeName>
    <deviceName>IDS SS-B/La</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100113</emdnCode>
    <emdnDescription>SS-B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1105</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:59:35.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169693814</udiDi>
    <basicUdiDi>B-05060169693814</basicUdiDi>
    <tradeName>IDS SS-A/Ro 60 kDa</tradeName>
    <deviceName>IDS SS-A/Ro 60 kDa</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1104</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:59:34.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169693807</udiDi>
    <basicUdiDi>B-05060169693807</basicUdiDi>
    <tradeName>IDS SS-A/Ro 52 kDa</tradeName>
    <deviceName>IDS SS-A/Ro 52 kDa</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1103</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:59:34.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169693791</udiDi>
    <basicUdiDi>B-05060169693791</basicUdiDi>
    <tradeName>IDS SS-A/Ro</tradeName>
    <deviceName>IDS SS-A/Ro</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1102</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:59:33.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169693784</udiDi>
    <basicUdiDi>B-05060169693784</basicUdiDi>
    <tradeName>IDS dsDNA IgG</tradeName>
    <deviceName>IDS dsDNA igG</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1101</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:59:29.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169693777</udiDi>
    <basicUdiDi>B-05060169693777</basicUdiDi>
    <tradeName>IDS ENA Screen</tradeName>
    <deviceName>IDS ENA Screen</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI1002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:59:28.568Z</lastUpdated>
  </row>
</eudamedExport>