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    <tradeName>IDKmonitor® Infliximab free ADA ELISA</tradeName>
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    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <lastUpdated>2026-07-31T12:25:36.455Z</lastUpdated>
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    <udiDi>04050598196520</udiDi>
    <basicUdiDi>B-04050598196520</basicUdiDi>
    <tradeName>IDKmonitor® Adalimumab free ADA ELISA</tradeName>
    <deviceName>IDKmonitor® Adalimumab free ADA ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <tradeName>Secukinumab ELISA</tradeName>
    <deviceName>Secukinumab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
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    <tradeName>Ustekinumab ELISA</tradeName>
    <deviceName>Ustekinumab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000572</manufacturerSrn>
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    <reference>710601</reference>
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    <udiDi>05430000412094</udiDi>
    <basicUdiDi>5430000412710401PV</basicUdiDi>
    <tradeName>Golimumab ELISA</tradeName>
    <deviceName>Golimumab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000572</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>710401</reference>
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    <lastUpdated>2026-07-31T08:05:33.796Z</lastUpdated>
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    <udiDi>05430000412070</udiDi>
    <basicUdiDi>5430000412710501Q2</basicUdiDi>
    <tradeName>Vedolizumab ELISA</tradeName>
    <deviceName>Vedolizumab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000572</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:05:33.016Z</lastUpdated>
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    <udiDi>05430000412063</udiDi>
    <basicUdiDi>5430000412710301PQ</basicUdiDi>
    <tradeName>Anti-Adalimumab ELISA</tradeName>
    <deviceName>Anti-Adalimumab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000572</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <lastUpdated>2026-07-31T08:05:28.996Z</lastUpdated>
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    <basicUdiDi>5430000412710201PK</basicUdiDi>
    <tradeName>Adalimumab ELISA</tradeName>
    <deviceName>Adalimumab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000572</manufacturerSrn>
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    <emdnDescription>ADALIMUMAB</emdnDescription>
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    <reference>710201</reference>
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    <lastUpdated>2026-07-31T08:05:28.193Z</lastUpdated>
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    <tradeName>Infliximab ELISA</tradeName>
    <deviceName>Infliximab ELISA</deviceName>
    <manufacturerName>Advanced Practical Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000572</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:05:27.390Z</lastUpdated>
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    <udiDi>03770024131000</udiDi>
    <basicUdiDi>3770024131INF-TDM2V</basicUdiDi>
    <tradeName>mAbXmise ITDM2</tradeName>
    <deviceName>mAbXmise – Monoclonal antibodies quantification  Kit Multiplex Infliximab, Adalimumab, Obinutuzumab, Secukinumab, Tocilizumab, Ustekinumab, Vedolizumab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITDM2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:57:41.960Z</lastUpdated>
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    <udiDi>03770024131024</udiDi>
    <basicUdiDi>B-03770024131024</basicUdiDi>
    <tradeName>mAbXmise OTDM1</tradeName>
    <deviceName>mAbXmise – Monoclonal antibodies quantification Kit Multiplex Nivolumab, Pembrolizumab, Trastuzumab, Cetuximab, Bevacizumab, Ipilimumab, Rituximab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102080704</emdnCode>
    <emdnDescription>RITUXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OTDM1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-19T17:47:32.948Z</lastUpdated>
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    <udiDi>03770024131017</udiDi>
    <basicUdiDi>B-03770024131017</basicUdiDi>
    <tradeName>mAbXmise ITDM1</tradeName>
    <deviceName>mAbXmise – Monoclonal antibodies quantification Kit Multiplex Infliximab &amp; Adalimumab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-19T17:47:32.147Z</lastUpdated>
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    <basicUdiDi>697518250P1146972</basicUdiDi>
    <tradeName>Free Anti-Rituximab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Anti-Rituximab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11447-50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:07:22.659Z</lastUpdated>
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    <tradeName>Anti-vedolizumab CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Anti-vedolizumab CLIA Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
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    <tradeName>Rituximab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
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    <tradeName>Free Anti-Ustekinumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
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    <tradeName>Ustekinumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
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