<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-441350NU</udiDi>
    <basicUdiDi>B-441350NU</basicUdiDi>
    <tradeName>SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2</tradeName>
    <deviceName>SYNCHRON® Systems Enzyme Validator Set Levels 1 and 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>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>441350</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:45:29.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>03661540304101</udiDi>
    <basicUdiDi>B-03661540304101</basicUdiDi>
    <tradeName>ChloroChek Standard Solution, 100 mmol/L</tradeName>
    <deviceName>ChloroChek Standard Solution, 100 mmol/L</deviceName>
    <manufacturerName>ELITechGroup Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006942</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:16:58.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950021766</udiDi>
    <basicUdiDi>84269500217665Q</basicUdiDi>
    <tradeName>ISE High Calibrator</tradeName>
    <deviceName>ISE High Calibrator</deviceName>
    <manufacturerName>Instrumentation Laboratory SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000009277</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0018469300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:02:58.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950021759</udiDi>
    <basicUdiDi>84269500217595T</basicUdiDi>
    <tradeName>ISE Low Calibrator</tradeName>
    <deviceName>ISE Low Calibrator</deviceName>
    <manufacturerName>Instrumentation Laboratory SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000009277</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0018469200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:02:57.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643962156</udiDi>
    <basicUdiDi>59026439BBCH713B3</basicUdiDi>
    <tradeName>05902643962156</tradeName>
    <deviceName>Wzorzec cholesterolu 5 ml</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</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>1-713-0005</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:24:09.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195210142</udiDi>
    <basicUdiDi>4049195CDTCMPNT35</basicUdiDi>
    <tradeName>ClinTest® Test Solution for CDT</tradeName>
    <deviceName>ClinTest® Test Solution</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:57:13.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751017</udiDi>
    <basicUdiDi>B-06936595751017</basicUdiDi>
    <tradeName>Multi Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JZ903TY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:55:51.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750133</udiDi>
    <basicUdiDi>B-06936595750133</basicUdiDi>
    <tradeName>Low-Density Lipoprotein Cholesterol Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JZ207Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:53:40.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750119</udiDi>
    <basicUdiDi>B-06936595750119</basicUdiDi>
    <tradeName>High-Density Lipoprotein Cholesterol Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JZ203Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:53:37.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514651337</udiDi>
    <basicUdiDi>B-05907514651337</basicUdiDi>
    <tradeName>IRON STANDARD 56</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-133</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T00:34:19.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514651306</udiDi>
    <basicUdiDi>B-05907514651306</basicUdiDi>
    <tradeName>TRIGLYCERIDES STANDARD 220</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-130</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T00:34:17.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514651252</udiDi>
    <basicUdiDi>B-05907514651252</basicUdiDi>
    <tradeName>URIC ACID STANDARD 5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-125</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T00:34:13.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514651160</udiDi>
    <basicUdiDi>B-05907514651160</basicUdiDi>
    <tradeName>PROTEIN STANDARD 4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-116</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T00:34:07.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643962163</udiDi>
    <basicUdiDi>59026439BBCH713B3</basicUdiDi>
    <tradeName>05902643962163</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-733-0005</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:15:19.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>13125620.01.0002028</udiDi>
    <basicUdiDi>PP12562CALLOESUNG20</basicUdiDi>
    <tradeName>13125620.01.0002028</tradeName>
    <deviceName></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>0.01.0002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T16:37:26.871Z</lastUpdated>
  </row>
</eudamedExport>