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    <tradeName>Golimumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Golimumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <tradeName>Anti-Adalimumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Anti-Adalimumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
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    <tradeName>Adalimumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Adalimumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
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    <emdnDescription>ADALIMUMAB</emdnDescription>
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    <tradeName>Vedolizumab CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Vedolizumab CLIA Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11446-50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:07:02.088Z</lastUpdated>
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    <udiDi>00630414615295</udiDi>
    <basicUdiDi>0405686902178VT</basicUdiDi>
    <tradeName>N Latex aTNFα</tradeName>
    <deviceName>IVDR_27_MAR EB_B_N_La_aTNFa</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873738</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:45.547Z</lastUpdated>
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    <udiDi>08437013457521</udiDi>
    <basicUdiDi>B-08437013457521</basicUdiDi>
    <tradeName>Promonitor-RTX</tradeName>
    <deviceName>Promonitor-RTX</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5130230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:52:36.693Z</lastUpdated>
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    <tradeName>Promonitor-GLM</tradeName>
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    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
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    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5200230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:52:35.892Z</lastUpdated>
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    <udiDi>08437013457507</udiDi>
    <basicUdiDi>B-08437013457507</basicUdiDi>
    <tradeName>Promonitor-ANTI-ETN</tradeName>
    <deviceName>Promonitor-ANTI-ETN</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:52:34.292Z</lastUpdated>
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    <basicUdiDi>B-08437013457491</basicUdiDi>
    <tradeName>Promonitor-ETN</tradeName>
    <deviceName>Promonitor-ETN</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5110230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:52:31.891Z</lastUpdated>
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    <udiDi>08437013457354</udiDi>
    <basicUdiDi>B-08437013457354</basicUdiDi>
    <tradeName>Promonitor-ANTI-GLM</tradeName>
    <deviceName>Promonitor-ANTI-GLM</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5210230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:52:30.287Z</lastUpdated>
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    <udiDi>04050598006164</udiDi>
    <basicUdiDi>B-04050598006164</basicUdiDi>
    <tradeName>IDKmonitor® Infliximab drug level</tradeName>
    <deviceName>IDKmonitor® Infliximab drug level</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9655.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:17.951Z</lastUpdated>
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    <udiDi>04050598006157</udiDi>
    <basicUdiDi>B-04050598006157</basicUdiDi>
    <tradeName>IDKmonitor® Adalimumab drug level ELISA</tradeName>
    <deviceName>IDKmonitor® Adalimumab drug level ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9657.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:13.152Z</lastUpdated>
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    <udiDi>04050598005846</udiDi>
    <basicUdiDi>B-04050598005846</basicUdiDi>
    <tradeName>IDKmonitor® Infliximab total ADA</tradeName>
    <deviceName>IDKmonitor® Infliximab total ADA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9654.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:44:24.200Z</lastUpdated>
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    <udiDi>04050598005839</udiDi>
    <basicUdiDi>B-04050598005839</basicUdiDi>
    <tradeName>IDKmonitor® Adalimumab total ADA ELISA</tradeName>
    <deviceName>IDKmonitor® Adalimumab total ADA ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9651.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:44:22.581Z</lastUpdated>
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    <basicUdiDi>B-04050598003866</basicUdiDi>
    <tradeName>IDKmonitor® Ustekinumab free ADA ELISA</tradeName>
    <deviceName>IDKmonitor® Ustekinumab free ADA ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
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    <tradeName>IDKmonitor® Ustekinumab drug level ELISA</tradeName>
    <deviceName>IDKmonitor® Ustekinumab drug level ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
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    <tradeName>IDKmonitor® Vedolizumab free ADA ELISA</tradeName>
    <deviceName>IDKmonitor® Vedolizumab free ADA ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>IDKmonitor® Vedolizumab drug level ELISA</tradeName>
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    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
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    <tradeName>IDKmonitor® Adalimumab drug level ELISA</tradeName>
    <deviceName>IDKmonitor® Adalimumab drug level ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
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    <emdnDescription>ADALIMUMAB</emdnDescription>
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    <tradeName>IDKmonitor® Infliximab drug level</tradeName>
    <deviceName>IDKmonitor® Infliximab drug level</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9655</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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