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    <tradeName>00884883001824</tradeName>
    <deviceName>MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MYCOPHENOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100278</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:52.287Z</lastUpdated>
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    <udiDi>00884883001817</udiDi>
    <basicUdiDi>B-00884883001817</basicUdiDi>
    <tradeName>00884883001817</tradeName>
    <deviceName>CEDIA Mycophenolic Acid Calibrators</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MYCOPHENOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100277</reference>
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    <lastUpdated>2026-07-05T09:13:50.701Z</lastUpdated>
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    <udiDi>00884883001800</udiDi>
    <basicUdiDi>B-00884883001800</basicUdiDi>
    <tradeName>00884883001800</tradeName>
    <deviceName>CEDIA Mycophenolic Acid</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>MYCOPHENOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100276</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:49.897Z</lastUpdated>
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    <udiDi>00884883001589</udiDi>
    <basicUdiDi>B-00884883001589</basicUdiDi>
    <tradeName>00884883001589</tradeName>
    <deviceName>CEDIA CsA PLUS Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100147</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:09.017Z</lastUpdated>
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    <udiDi>00884883001299</udiDi>
    <basicUdiDi>B-00884883001299</basicUdiDi>
    <tradeName>00884883001299</tradeName>
    <deviceName>CEDIA Cyclosporine PLUS High Range Calibrators (450/2000)</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:14.544Z</lastUpdated>
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    <udiDi>00884883000537</udiDi>
    <basicUdiDi>B-00884883000537</basicUdiDi>
    <tradeName>00884883000537</tradeName>
    <deviceName>QMS Everolimus Immunoassay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080606</emdnCode>
    <emdnDescription>EVEROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0380005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:12.866Z</lastUpdated>
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    <udiDi>03770029302023</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Mobile Phase A</tradeName>
    <deviceName>DOSIMMUNE</deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40102-55</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:12:42.379Z</lastUpdated>
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    <udiDi>06947145502157</udiDi>
    <basicUdiDi>B-06947145502157</basicUdiDi>
    <tradeName>MAGLUMI FK 506 (CLIA)</tradeName>
    <deviceName>FK 506 (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080603</emdnCode>
    <emdnDescription>TACROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130207003M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:45.803Z</lastUpdated>
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    <udiDi>06947145501457</udiDi>
    <basicUdiDi>B-06947145501457</basicUdiDi>
    <tradeName>MAGLUMI CSA (CLIA)</tradeName>
    <deviceName>CSA (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130207001M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:33.800Z</lastUpdated>
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    <udiDi>03770029302030</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Mobile Phase B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40103-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:14.472Z</lastUpdated>
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    <udiDi>03770029302047</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>System Cleaning Phase</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40104-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:14.444Z</lastUpdated>
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    <udiDi>03770029302054</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Extraction Buffer (IM-M)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40105-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:14.425Z</lastUpdated>
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    <udiDi>03770029302061</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Internal Standard Set (IM-M)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40106-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:14.411Z</lastUpdated>
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    <udiDi>03770029302078</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Calibrator Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40120-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:14.379Z</lastUpdated>
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    <udiDi>03770029302085</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40110-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:56.108Z</lastUpdated>
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    <udiDi>03770029302092</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Column Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40142-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:56.089Z</lastUpdated>
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    <udiDi>03770029302122</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>PACK 1400</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40190-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:56.074Z</lastUpdated>
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    <udiDi>03770029302139</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>PACK 1000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40180-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:56.058Z</lastUpdated>
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    <udiDi>03770029302146</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Internal Standard Set (IM-A)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40175-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:56.046Z</lastUpdated>
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    <udiDi>03770029302153</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Extraction Buffer (IM-A)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-41085-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:56.031Z</lastUpdated>
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