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<eudamedExport entity="devices">
  <row>
    <udiDi>00630414600451</udiDi>
    <basicUdiDi>0405686900790VZ</basicUdiDi>
    <tradeName>Atellica IM Insulin Calibrator (IRI CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_IRI_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>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995629</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:15:03.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598253</udiDi>
    <basicUdiDi>0405686901719W2</basicUdiDi>
    <tradeName>Atellica IM Homocysteine Calibrator (HCY CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_HCY 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>W0102152204</emdnCode>
    <emdnDescription>CARDIAC MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995498</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:24.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598222</udiDi>
    <basicUdiDi>0405686901835W5</basicUdiDi>
    <tradeName>Atellica IM Calibrator 30 (CAL 30)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_Calibrator 30</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>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995495</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:21.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-701131N9</udiDi>
    <basicUdiDi>B-701131N9</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® MPO Calibrators</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701131</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:28:47.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>6971771202235</udiDi>
    <basicUdiDi>B-6971771202235</basicUdiDi>
    <tradeName>Lysun</tradeName>
    <deviceName>One Step Multi-Drug Rapid Test(Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RPS/15/2024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:00:37.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-663940RM</udiDi>
    <basicUdiDi>B-663940RM</basicUdiDi>
    <tradeName>Immunochemistry Systems CAL 2 Calibrator 2</tradeName>
    <deviceName>Immunochemistry Systems CAL 2 Calibrator 2</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>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>663940</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:55.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041044040</udiDi>
    <basicUdiDi>B-62230041044040</basicUdiDi>
    <tradeName>"25-OH Vitamin D Calibrator Set</tradeName>
    <deviceName>"25-OH Vitamin D Calibrator Set</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152206</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>393 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:30:36.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700804611</udiDi>
    <basicUdiDi>37017008HBAE043A</basicUdiDi>
    <tradeName>HbA1c Enzymatic Calibrator Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBAE-4301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:57.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700804628</udiDi>
    <basicUdiDi>37017008HBAE043A</basicUdiDi>
    <tradeName>HbA1c Enzymatic Calibrator Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBAE-4303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:57.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700821113</udiDi>
    <basicUdiDi>37017008HBAC042Y</basicUdiDi>
    <tradeName>HbA1c CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBAC-4301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:17.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700821120</udiDi>
    <basicUdiDi>37017008HBAC042Y</basicUdiDi>
    <tradeName>HbA1c CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBAC-4302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:16.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700821137</udiDi>
    <basicUdiDi>37017008HBAC042Y</basicUdiDi>
    <tradeName>HbA1c CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBAC-4303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:16.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700821144</udiDi>
    <basicUdiDi>37017008HBAC042Y</basicUdiDi>
    <tradeName>HbA1c CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBAC-4304</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:16.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700821717</udiDi>
    <basicUdiDi>37017008ICRP049G</basicUdiDi>
    <tradeName>CRP IP CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICRP-4311</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:16.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700821724</udiDi>
    <basicUdiDi>37017008ICRP049G</basicUdiDi>
    <tradeName>CRP IP CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICRP-4312</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:16.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700821731</udiDi>
    <basicUdiDi>37017008ICRP049G</basicUdiDi>
    <tradeName>CRP IP CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICRP-4313</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:16.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700821748</udiDi>
    <basicUdiDi>37017008ICRP049G</basicUdiDi>
    <tradeName>CRP IP CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICRP-4314</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:16.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700821755</udiDi>
    <basicUdiDi>37017008ICRP049G</basicUdiDi>
    <tradeName>CRP IP CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICRP-4315</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:16.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700822219</udiDi>
    <basicUdiDi>37017008IFRT04B5</basicUdiDi>
    <tradeName>FERRITIN CALIBRATOR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFRT-4230</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:16.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700822714</udiDi>
    <basicUdiDi>37017008IMAL048K</basicUdiDi>
    <tradeName>µALBUMIN IP CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMAL-4311</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:15.639Z</lastUpdated>
  </row>
</eudamedExport>