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    <tradeName>Free Anti Pembrolizumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Anti Pembrolizumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-26T16:31:55.976Z</lastUpdated>
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    <tradeName>Rapamycin CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Rapamycin CLIA Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>RAPAMYCIN (SIROLIMUS)</emdnDescription>
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    <tradeName>Free Anti-Secukinumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
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    <tradeName>Secukinumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Secukinumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
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    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
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    <basicUdiDi>697518250F114522F</basicUdiDi>
    <tradeName>Anti-vedolizumab CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Anti-vedolizumab CLIA Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
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    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>697518250F114342D</basicUdiDi>
    <tradeName>Rituximab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Rituximab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>RITUXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:31:18.715Z</lastUpdated>
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    <tradeName>Pembrolizumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Pembrolizumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
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    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Nivolumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Nivolumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
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    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11435</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:31:11.409Z</lastUpdated>
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    <basicUdiDi>697518250F114332B</basicUdiDi>
    <tradeName>Free Anti-Ustekinumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Anti-Ustekinumab 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>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11433</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:31:10.329Z</lastUpdated>
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    <tradeName>Ustekinumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Ustekinumab 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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    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11432</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:31:08.996Z</lastUpdated>
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    <basicUdiDi>697518250F114382M</basicUdiDi>
    <tradeName>Free Anti-Bevacizumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Anti-Bevacizumab 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>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11438</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:31:08.170Z</lastUpdated>
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    <tradeName>Bevacizumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Bevacizumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
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    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:31:02.067Z</lastUpdated>
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    <tradeName>Anti-Infliximab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Anti-Infliximab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:31:00.590Z</lastUpdated>
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    <tradeName>Infliximab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Infliximab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
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    <emdnDescription>INFLIXIMAB</emdnDescription>
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    <lastUpdated>2026-06-26T16:30:59.699Z</lastUpdated>
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    <tradeName>Anti-Golimumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
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    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-26T16:30:58.191Z</lastUpdated>
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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>
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    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
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    <tradeName>Anti-Adalimumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
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    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-26T16:30:51.292Z</lastUpdated>
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    <tradeName>Adalimumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Adalimumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11426</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:30:49.772Z</lastUpdated>
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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>
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    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-26T16:30:13.965Z</lastUpdated>
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    <tradeName>Rifampicin CLIA Kit（Chemiluminescence Immunoassay）</tradeName>
    <deviceName>Rifampicin CLIA Kit（Chemiluminescence Immunoassay）</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11445</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:30:10.205Z</lastUpdated>
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