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<eudamedExport entity="devices">
  <row>
    <udiDi>00630414597201</udiDi>
    <basicUdiDi>0405686900761VS</basicUdiDi>
    <tradeName>Atellica CH Albumin BCP Calibrator (AlbP CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_ALBP_Cal</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:37.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595740</udiDi>
    <basicUdiDi>0405686900823VP</basicUdiDi>
    <tradeName>Atellica CH A‑LYTE IMT Standard A</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_IMT Standard A</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099304</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:04.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595719</udiDi>
    <basicUdiDi>0405686900824VR</basicUdiDi>
    <tradeName>Atellica CH A‑LYTE IMT Standard B + Salt Bridge</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_IMT Standard B + Salt Bridge</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099306</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:02.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005183</udiDi>
    <basicUdiDi>0405686900206UR</basicUdiDi>
    <tradeName>Dimension Prealbumin Calibrator</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_PALB_cal</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:06:49.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840733103285</udiDi>
    <basicUdiDi>008407331REVOGENECLA002TH</basicUdiDi>
    <tradeName>Revogene® Check</tradeName>
    <deviceName>Revogene® Check</deviceName>
    <manufacturerName>Meridian Bioscience Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044096</manufacturerSrn>
    <authorisedRepresentativeName>Meridian Bioscience Europe S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000010460</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610220</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:25:28.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>13125620.01.0001011</udiDi>
    <basicUdiDi>PP12562CALLOESUNG20</basicUdiDi>
    <tradeName>13125620.01.0001011</tradeName>
    <deviceName>Solution</deviceName>
    <manufacturerName>Axel Löser Messtechnik</manufacturerName>
    <manufacturerSrn>DE-MF-000023401</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0.01.0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:41:08.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-U172053W</udiDi>
    <basicUdiDi>B-U172053W</basicUdiDi>
    <tradeName>D-U172053W</tradeName>
    <deviceName>ISE Calibrator Low</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U17205</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:27:28.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-U172063Y</udiDi>
    <basicUdiDi>B-U172063Y</basicUdiDi>
    <tradeName>D-U172063Y</tradeName>
    <deviceName>ISE Calibrator High</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U17206</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:27:25.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MULTICALIBRATOREUG</udiDi>
    <basicUdiDi>B-MULTICALIBRATOREUG</basicUdiDi>
    <tradeName>MULTICALIBRATORE</tradeName>
    <deviceName>MULTICALIBRATORE</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC40-2-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:18:25.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS3013AS</udiDi>
    <basicUdiDi>B-MS3013AS</basicUdiDi>
    <tradeName>ClinCal® Urine Calibrator Set, lyophil., for Nicotine and Metabolites (Level 0 - 6)</tradeName>
    <deviceName>Urine Calibrator Set for Nicotine and Metabolites</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS3013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:15:13.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS3012AQ</udiDi>
    <basicUdiDi>B-MS3012AQ</basicUdiDi>
    <tradeName>ClinMass® Internal Standard for Nicotine and Metabolites</tradeName>
    <deviceName>Internal Standard for Nicotine and Metabolites</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:14:53.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS1312AR</udiDi>
    <basicUdiDi>B-MS1312AR</basicUdiDi>
    <tradeName>ClinMass® Internal Standard, lyophil., for Immunosuppressants (d₁₂-Cyclosporine A, ¹³Cd₂-Tacrolimus,  ¹³Cd₃-Sirolimus, ¹³C₂d₄-Everolimus)</tradeName>
    <deviceName>Internal Standard for Immunosuppressants (d₁₂-Cyclosporine A, ¹³Cd₂-Tacrolimus,  ¹³Cd₃-Sirolimus, ¹³C₂d₄-Everolimus)</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS1312</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:14:33.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS1112AF</udiDi>
    <basicUdiDi>B-MS1112AF</basicUdiDi>
    <tradeName>ClinMass® Internal Standard, lyophil., for Immunosuppressants (Cyclosporine D)</tradeName>
    <deviceName>Internal Standard for Immunosuppressants (Cyclosporine D)</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS1112</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:14:26.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS1012AA</udiDi>
    <basicUdiDi>B-MS1012AA</basicUdiDi>
    <tradeName>ClinMass® Internal Standard, lyophil., for Immunosuppressants (Ascomycin)</tradeName>
    <deviceName>Internal Standard for Immunosuppressants (Ascomycin)</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS1012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:14:19.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K91201-084G</udiDi>
    <basicUdiDi>B-K91201-084G</basicUdiDi>
    <tradeName>D-K91201-084G</tradeName>
    <deviceName>C-reactive Protein (CRP) Calibrator</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:41.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS02559B</udiDi>
    <basicUdiDi>B-IS02559B</basicUdiDi>
    <tradeName>HbA1c Hemoglobin Standard</tradeName>
    <deviceName>HbA1c Hemoglobin Standard</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS0255</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:42:22.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS02479C</udiDi>
    <basicUdiDi>B-IS02479C</basicUdiDi>
    <tradeName>Lipoprotein A Standard</tradeName>
    <deviceName>Lipoprotein A</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS0247</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:42:21.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS02469A</udiDi>
    <basicUdiDi>B-IS02469A</basicUdiDi>
    <tradeName>Immunoglobulin E Standard</tradeName>
    <deviceName>Immunoglobulin E Standard</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS0246</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:42:20.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS024598</udiDi>
    <basicUdiDi>B-IS024598</basicUdiDi>
    <tradeName>Ferritin Standard</tradeName>
    <deviceName>Ferritin Standard</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS0245</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:42:17.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS024496</udiDi>
    <basicUdiDi>B-IS024496</basicUdiDi>
    <tradeName>Rheumatoid Factor Standard</tradeName>
    <deviceName>Rheumatoid Factor Standard</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS0244</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:42:15.997Z</lastUpdated>
  </row>
</eudamedExport>