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<eudamedExport entity="devices">
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    <udiDi>04250289500333</udiDi>
    <basicUdiDi>B-04250289500333</basicUdiDi>
    <tradeName>AESKUSLIDES® EMA IgA</tradeName>
    <deviceName>AESKUSLIDES® EMA</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100603</emdnCode>
    <emdnDescription>ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>512.050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:47.460Z</lastUpdated>
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  <row>
    <udiDi>04099466110015</udiDi>
    <basicUdiDi>B-04099466110015</basicUdiDi>
    <tradeName>04099466110015</tradeName>
    <deviceName>Serazym® Nucleo ANA screen plus</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:41.799Z</lastUpdated>
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  <row>
    <udiDi>04099466105813</udiDi>
    <basicUdiDi>B-04099466105813</basicUdiDi>
    <tradeName>04099466105813</tradeName>
    <deviceName>Serazym® Anti-dsDNA IgG</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-058</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:37.000Z</lastUpdated>
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  <row>
    <udiDi>04099466105417</udiDi>
    <basicUdiDi>B-04099466105417</basicUdiDi>
    <tradeName>04099466105417</tradeName>
    <deviceName>Serazym® Anti-Cardiolipin-ß2-GP-1 IgG/IgM</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-054</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:33.814Z</lastUpdated>
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  <row>
    <udiDi>00845533001892</udiDi>
    <basicUdiDi>B-00845533001892</basicUdiDi>
    <tradeName>ANA Hep-2</tradeName>
    <deviceName>ANA Hep-2</deviceName>
    <manufacturerName>ZEUS Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000026845</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA2500A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:34:13.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIATPO102001</udiDi>
    <basicUdiDi>B-+ENTIATPO102001</basicUdiDi>
    <tradeName>+ENTIATPO102001</tradeName>
    <deviceName>NovaLisa® Anti-TPO</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</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>ATPO1020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:08:58.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIATG10100A</udiDi>
    <basicUdiDi>B-+ENTIATG10100A</basicUdiDi>
    <tradeName>+ENTIATG10100A</tradeName>
    <deviceName>NovaLisa® Anti-TG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATG1010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:08:53.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891324599</udiDi>
    <basicUdiDi>803389132CHORUSMPO200B4</basicUdiDi>
    <tradeName>CHORUS MPO</tradeName>
    <deviceName>CHORUS MPO</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86120</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:48:05.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416836</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Mi-2</tradeName>
    <deviceName>BioCLIA Autoimmune Reagent Kit,BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set</deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02274</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:28:03.378Z</lastUpdated>
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  <row>
    <udiDi>05425023681695</udiDi>
    <basicUdiDi>542502368BDDANAYE</basicUdiDi>
    <tradeName>BlueDiverDot ANA + DFS-70 IgG</tradeName>
    <deviceName>BlueDiver Dot ANA Screening</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLH12DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:59:33.485Z</lastUpdated>
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  <row>
    <udiDi>00630414635439</udiDi>
    <basicUdiDi>0405686902255VL</basicUdiDi>
    <tradeName>ADVIA Centaur Neurofilament Light Chain (NfL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_KIT_sNfL 100T Kit</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11553990</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:59.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414608754</udiDi>
    <basicUdiDi>0405686902269VX</basicUdiDi>
    <tradeName>Atellica IM Anti-Thyroid Peroxidase II (aTPOII)</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_KIT_aTPOII</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11206076</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:09.529Z</lastUpdated>
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  <row>
    <udiDi>00630414245317</udiDi>
    <basicUdiDi>0405686901371VG</basicUdiDi>
    <tradeName>Atellica IM Anti-Thyroglobulin II (aTgII)</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_aTgII</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11201759</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:23:28.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-anti-tTG706-AEYS</udiDi>
    <basicUdiDi>B-anti-tTG706-AEYS</basicUdiDi>
    <tradeName>Anti-tTG IgG Anti-tissue Transglutaminase IgG Antibody (CLIA)</tradeName>
    <deviceName>Anti-tTG IgG Anti-tissue Transglutaminase IgG Antibody (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"anti-tTG706-AE10Y, anti-tTG706-AE10N, anti-tTG706-AE20Y, anti-tTG706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:04.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-anti-dsDNA706-AEST</udiDi>
    <basicUdiDi>B-anti-dsDNA706-AEST</basicUdiDi>
    <tradeName>Anti-dsDNA IgG Anti-double-stranded DNA IgG Antibody(CLIA)</tradeName>
    <deviceName>Anti-dsDNA IgG Anti-double-stranded DNA IgG Antibody(CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>anti-dsDNA706-AE10Y, anti-dsDNA706-AE10N, anti-dsDNA706-AE20Y, anti-dsDNA706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:04.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R994496T</udiDi>
    <basicUdiDi>B-R994496T</basicUdiDi>
    <tradeName>D-R994496T</tradeName>
    <deviceName>Anti-Phospholipid Screen IgG/IgM</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100599</emdnCode>
    <emdnDescription>ANTI-PHOSPHOLIP SYNDROME - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R99449</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:39.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R01210YQ</udiDi>
    <basicUdiDi>B-R01210YQ</basicUdiDi>
    <tradeName>D-R01210YQ</tradeName>
    <deviceName>Anti-Transglutaminase IgA</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01210</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:23:15.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TRAb-04100Y3</udiDi>
    <basicUdiDi>B-KR-TRAb-04100Y3</basicUdiDi>
    <tradeName>INNODX TRAb CMIA</tradeName>
    <deviceName>INNODX TRAb CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TRAb-04100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:25.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TRAb-0250LT</udiDi>
    <basicUdiDi>B-KR-TRAb-0250LT</basicUdiDi>
    <tradeName>INNODX TRAb CMIA</tradeName>
    <deviceName>INNODX TRAb CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TRAb-0250</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:23.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TRAb-02200XS</udiDi>
    <basicUdiDi>B-KR-TRAb-02200XS</basicUdiDi>
    <tradeName>INNODX TRAb CMIA</tradeName>
    <deviceName>INNODX TRAb CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TRAb-02200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:21.962Z</lastUpdated>
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</eudamedExport>