<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08056771200301</udiDi>
    <basicUdiDi>B-08056771200301</basicUdiDi>
    <tradeName>LIAISON® Anti-TPO</tradeName>
    <deviceName>LIAISON® Anti-TPO</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:40:28.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GGTTG-402aOGJP</udiDi>
    <basicUdiDi>B-GGTTG-402aOGJP</basicUdiDi>
    <tradeName>Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)</tradeName>
    <deviceName>Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GGTTG-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:47.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GGTTG-402aHGJ2</udiDi>
    <basicUdiDi>B-GGTTG-402aHGJ2</basicUdiDi>
    <tradeName>Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)</tradeName>
    <deviceName>Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GGTTG-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:46.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289852395</udiDi>
    <basicUdiDi>B-06933289852395</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Antibody to Thyroid Peroxidase (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA47P0006</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:22.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289852364</udiDi>
    <basicUdiDi>B-06933289852364</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Antibody to Thyroid Peroxidase (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA47P0003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:18.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289852357</udiDi>
    <basicUdiDi>B-06933289852357</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Antibody to Thyroglobulin (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA48P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:18.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289852388</udiDi>
    <basicUdiDi>B-06933289852388</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Antibody to Thyroid Peroxidase (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA47P0005</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:17.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289852371</udiDi>
    <basicUdiDi>B-06933289852371</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Antibody to Thyroid Peroxidase (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA47P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:16.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289852340</udiDi>
    <basicUdiDi>B-06933289852340</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Antibody to Thyroglobulin (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA48P0003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:52:59.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289852333</udiDi>
    <basicUdiDi>B-06933289852333</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Antibody to Thyroglobulin (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA48P0002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:52:58.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289852326</udiDi>
    <basicUdiDi>B-06933289852326</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Antibody to Thyroglobulin (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA48P0001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:52:58.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680103</udiDi>
    <basicUdiDi>B-04260158680103</basicUdiDi>
    <tradeName>SS-B</tradeName>
    <deviceName>SS-B</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100113</emdnCode>
    <emdnDescription>SS-B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:19.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680073</udiDi>
    <basicUdiDi>B-04260158680073</basicUdiDi>
    <tradeName>SS-A</tradeName>
    <deviceName>SS-A</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:15.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680066</udiDi>
    <basicUdiDi>B-04260158680066</basicUdiDi>
    <tradeName>Sm</tradeName>
    <deviceName>Sm</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100111</emdnCode>
    <emdnDescription>SM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:14.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680059</udiDi>
    <basicUdiDi>B-04260158680059</basicUdiDi>
    <tradeName>RNP complex</tradeName>
    <deviceName>RNP complex</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100114</emdnCode>
    <emdnDescription>U1-SNRNP - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:13.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680042</udiDi>
    <basicUdiDi>B-04260158680042</basicUdiDi>
    <tradeName>U1-70</tradeName>
    <deviceName>U1-70</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100114</emdnCode>
    <emdnDescription>U1-SNRNP - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:12.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680035</udiDi>
    <basicUdiDi>B-04260158680035</basicUdiDi>
    <tradeName>ENA Profile</tradeName>
    <deviceName>ENA Profile</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:08.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680028</udiDi>
    <basicUdiDi>B-04260158680028</basicUdiDi>
    <tradeName>ENA Screen</tradeName>
    <deviceName>ENA Screen</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:07.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680011</udiDi>
    <basicUdiDi>B-04260158680011</basicUdiDi>
    <tradeName>ANA Profile</tradeName>
    <deviceName>ANA Profile</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:07.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260158680004</udiDi>
    <basicUdiDi>B-04260158680004</basicUdiDi>
    <tradeName>ANA Screen</tradeName>
    <deviceName>ANA Screen</deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:31:06.246Z</lastUpdated>
  </row>
</eudamedExport>