<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-MS99200TR</udiDi>
    <basicUdiDi>B-MS99200TR</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Add-on Set for Immunosuppressants in Whole Blood</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS99200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:42.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS1300AJ</udiDi>
    <basicUdiDi>B-MS1300AJ</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Complete Kit, advanced, for Immunosuppressants in Whole Blood AUTOMATED ON-LINE  with Filter-Plates</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS1300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:14:32.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS1200AD</udiDi>
    <basicUdiDi>B-MS1200AD</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Complete Kit, advanced, for Immunosuppressants in Whole Blood AUTOMATED ON-LINE</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS1200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:14:31.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS1100A8</udiDi>
    <basicUdiDi>B-MS1100A8</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Complete Kit, advanced, for Immunosuppressants in Whole Blood ON-LINE</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS1100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:14:24.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4320PMPAM9</udiDi>
    <basicUdiDi>B-4320PMPAM9</basicUdiDi>
    <tradeName>Mycophenolic Acid Reagent Set</tradeName>
    <deviceName>Mycophenolic Acid Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4320 P MPA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:44:51.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978945081153</udiDi>
    <basicUdiDi>B-06978945081153</basicUdiDi>
    <tradeName>Three Immune Inhibitors Kit(LC-MS/MS)</tradeName>
    <deviceName>Three Immune Inhibitors Kit(LC-MS/MS)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAZK902A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:00.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883012622</udiDi>
    <basicUdiDi>B-00884883012622</basicUdiDi>
    <tradeName>00884883012622</tradeName>
    <deviceName>QMS Teico Rgt Kit</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>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374645</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:07.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883012615</udiDi>
    <basicUdiDi>B-00884883012615</basicUdiDi>
    <tradeName>00884883012615</tradeName>
    <deviceName>QMS Teicoplanin Cal Kit</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>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374652</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:04.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883012608</udiDi>
    <basicUdiDi>B-00884883012608</basicUdiDi>
    <tradeName>00884883012608</tradeName>
    <deviceName>QMS Teicoplanin Ctrl Kit</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>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374660</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:03.242Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <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>
  </row>
  <row>
    <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>
    <riskClass>IVD Sınıf C</riskClass>
    <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>
  </row>
  <row>
    <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>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40180-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:56.058Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
</eudamedExport>