<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06947145593728</udiDi>
    <basicUdiDi>69471455C12Y8</basicUdiDi>
    <tradeName>Biossays Rheumatism &amp; Inflammation Multi-Calibrator</tradeName>
    <deviceName>Rheumatism &amp; Inflammation Multi-Calibrator</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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1601020047</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:43:11.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145589226</udiDi>
    <basicUdiDi>69471455C07YF</basicUdiDi>
    <tradeName>Biossays Protein Multiconstituent Calibrators</tradeName>
    <deviceName>Protein Multiconstituent Calibrators</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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1601020046</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:43:09.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145589202</udiDi>
    <basicUdiDi>69471455C06YD</basicUdiDi>
    <tradeName>Biossays Immunoassay Multiconstituent Calibrators</tradeName>
    <deviceName>Immunoassay Multiconstituent Calibrators</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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1601020045</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:43:07.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597492</udiDi>
    <basicUdiDi>0405686901837W9</basicUdiDi>
    <tradeName>Atellica CH Chemistry Calibrator (CHEM CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_Chemistry Calibrator</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>11099411</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:47.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597225</udiDi>
    <basicUdiDi>0405686901704VM</basicUdiDi>
    <tradeName>Atellica CH ENZ 1 Calibrator (ENZ 1 CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_ENZ 1 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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099317</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:44.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005190</udiDi>
    <basicUdiDi>0405686901189VR</basicUdiDi>
    <tradeName>Dimension® Special Protein Calibrator</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_SP 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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:48.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597379</udiDi>
    <basicUdiDi>0405686900777W9</basicUdiDi>
    <tradeName>Atellica CH CHEM III Calibrator (CHEM III CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_CHEM III_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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099335</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:41.579Z</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>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>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-ECH0184999AA</udiDi>
    <basicUdiDi>B-ECH0184999AA</basicUdiDi>
    <tradeName>D-ECH0184999AA</tradeName>
    <deviceName>Calibrator for Automatic System (Multi-Cal)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0184999</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:44.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH0183999A3</udiDi>
    <basicUdiDi>B-ECH0183999A3</basicUdiDi>
    <tradeName>D-ECH0183999A3</tradeName>
    <deviceName>Calibrator for Automatic System (Multi-Cal)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0183999</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:39.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01829999U</udiDi>
    <basicUdiDi>B-ECH01829999U</basicUdiDi>
    <tradeName>D-ECH01829999U</tradeName>
    <deviceName>Calibrator for Automatic System (Multi-Cal)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0182999</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:27.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01819999M</udiDi>
    <basicUdiDi>B-ECH01819999M</basicUdiDi>
    <tradeName>D-ECH01819999M</tradeName>
    <deviceName>Calibrator for Automatic System (Multi-Cal)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0181999</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:51.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-B23634UE</udiDi>
    <basicUdiDi>B-B23634UE</basicUdiDi>
    <tradeName>Unicel DxC SYNCHRON Systems HDL Calibrator</tradeName>
    <deviceName>Unicel DxC SYNCHRON Systems HDL Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B23634</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:50:35.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9988DK</udiDi>
    <basicUdiDi>B-9988DK</basicUdiDi>
    <tradeName>ClinCal® Urine Calibrator, lyophil., for Trace Elements</tradeName>
    <deviceName>Urine Calibrator for Trace Elements</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>9988</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:59:24.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9943CV</udiDi>
    <basicUdiDi>B-9943CV</basicUdiDi>
    <tradeName>ClinCal® Whole Blood Calibrator, lyophil., for Trace Elements</tradeName>
    <deviceName>Whole Blood Calibrator for Trace Elements</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>9943</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:59:23.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9925CT</udiDi>
    <basicUdiDi>B-9925CT</basicUdiDi>
    <tradeName>ClinCal® Urine Calibrator, lyophil., for Phenolic Compounds</tradeName>
    <deviceName>Urine Calibrator for Phenolic Compounds</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>9925</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:59:22.615Z</lastUpdated>
  </row>
</eudamedExport>