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<eudamedExport entity="devices">
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    <basicUdiDi>697015090000315HC</basicUdiDi>
    <tradeName>Anti-GBM IgG 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ1708</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:51:06.086Z</lastUpdated>
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  <row>
    <udiDi>06942028502569</udiDi>
    <basicUdiDi>B-06942028502569</basicUdiDi>
    <tradeName>Anti-trophoblast cell membrane antibody(TA-Ab) Detection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-trophoblast cell membrane antibody(TA-Ab) Detection Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB2201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:50.762Z</lastUpdated>
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    <udiDi>06942028501968</udiDi>
    <basicUdiDi>B-06942028501968</basicUdiDi>
    <tradeName>Anti-Human Chorionic Gonadotropin antibody (HCG-Ab) Detection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-Human Chorionic Gonadotropin antibody (HCG-Ab) Detection Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB1401</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:25.438Z</lastUpdated>
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    <udiDi>06942028501920</udiDi>
    <basicUdiDi>B-06942028501920</basicUdiDi>
    <tradeName>Anti-zona pellucida antibody IgM(ZP-IgM) Detection Kit   (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-zona pellucida antibody IgM(ZP-IgM) Detection Kit   (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB1301</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:24.513Z</lastUpdated>
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  <row>
    <udiDi>06942028501883</udiDi>
    <basicUdiDi>B-06942028501883</basicUdiDi>
    <tradeName>Anti-zona pellucida antibody IgG(ZP-IgG) Detection Kit   (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-zona pellucida antibody IgG(ZP-IgG) Detection Kit   (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB1201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:23.072Z</lastUpdated>
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  <row>
    <udiDi>05425023687048</udiDi>
    <basicUdiDi>542502368BDGASTRITISLY</basicUdiDi>
    <tradeName>Biermer Atrophic Gastritis Dot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD BAGD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.500Z</lastUpdated>
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  <row>
    <udiDi>05425023687345</udiDi>
    <basicUdiDi>542502368BDDGASTRITISC2</basicUdiDi>
    <tradeName>Biermer Atrophic Gastritis Dot for BDI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD BAGDBD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:49.901Z</lastUpdated>
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  <row>
    <udiDi>05425023688076</udiDi>
    <basicUdiDi>542502368BDGASTRITISLY</basicUdiDi>
    <tradeName>DIASpot Gastritis IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAPDTIFPCA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:49.246Z</lastUpdated>
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  <row>
    <udiDi>05425023688229</udiDi>
    <basicUdiDi>542502368BDDGASTRITISC2</basicUdiDi>
    <tradeName>DIASpot Neptune Gastritis IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAPDTIFPCAN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:48.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>05411967002559</udiDi>
    <basicUdiDi>5411967SPMGS135</basicUdiDi>
    <tradeName>SpermMar Test IgG Latex bead solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPMG_L</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:51:29.752Z</lastUpdated>
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  <row>
    <udiDi>05056509600451</udiDi>
    <basicUdiDi>B-05056509600451</basicUdiDi>
    <tradeName>RiaRSR™ AChRAb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RSR Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025180</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109022</emdnCode>
    <emdnDescription>ACETYLCHOLIN RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB/100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:23:40.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056509600444</udiDi>
    <basicUdiDi>B-05056509600444</basicUdiDi>
    <tradeName>RiaRSR™ AChRAb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RSR Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025180</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109022</emdnCode>
    <emdnDescription>ACETYLCHOLIN RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB/25</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:23:39.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056509600284</udiDi>
    <basicUdiDi>B-05056509600284</basicUdiDi>
    <tradeName>RiaRSR™ MuSK Ab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RSR Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025180</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSK/25</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:23:38.919Z</lastUpdated>
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  <row>
    <udiDi>05056509600253</udiDi>
    <basicUdiDi>B-05056509600253</basicUdiDi>
    <tradeName>ElisaRSR™ Fast AChRAb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RSR Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025180</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109022</emdnCode>
    <emdnDescription>ACETYLCHOLIN RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAE/96</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:23:36.217Z</lastUpdated>
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  <row>
    <udiDi>05056509600154</udiDi>
    <basicUdiDi>B-05056509600154</basicUdiDi>
    <tradeName>RiaRSR™ AChRAb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RSR Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025180</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109022</emdnCode>
    <emdnDescription>ACETYLCHOLIN RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBA/100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:23:28.118Z</lastUpdated>
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  <row>
    <udiDi>05056509600147</udiDi>
    <basicUdiDi>B-05056509600147</basicUdiDi>
    <tradeName>RiaRSR™ AChRAb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RSR Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025180</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109022</emdnCode>
    <emdnDescription>ACETYLCHOLIN RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBA/50</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:23:27.215Z</lastUpdated>
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  <row>
    <udiDi>05056509600130</udiDi>
    <basicUdiDi>B-05056509600130</basicUdiDi>
    <tradeName>RiaRSR™ AChRAb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RSR Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025180</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109022</emdnCode>
    <emdnDescription>ACETYLCHOLIN RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBA/25</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:23:26.319Z</lastUpdated>
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  <row>
    <udiDi>05056509600048</udiDi>
    <basicUdiDi>B-05056509600048</basicUdiDi>
    <tradeName>ElisaRSR™ AChRAb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RSR Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025180</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109022</emdnCode>
    <emdnDescription>ACETYLCHOLIN RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACE/96</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:23:18.216Z</lastUpdated>
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  <row>
    <udiDi>05056509600031</udiDi>
    <basicUdiDi>B-05056509600031</basicUdiDi>
    <tradeName>ElisaRSR™ 21-OH Ab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RSR Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025180</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21E/96/R</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:23:17.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056509600024</udiDi>
    <basicUdiDi>B-05056509600024</basicUdiDi>
    <tradeName>ElisaRSR™ 21-OH Ab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RSR Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025180</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21E/96</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:23:16.418Z</lastUpdated>
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