<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-71266HA</udiDi>
    <basicUdiDi>B-71266HA</basicUdiDi>
    <tradeName>CALIBRATOR 80</tradeName>
    <deviceName>CALIBRATOR 80</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>71266</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:00.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-70305GL</udiDi>
    <basicUdiDi>B-70305GL</basicUdiDi>
    <tradeName>Standard Solution Set</tradeName>
    <deviceName>Standard Solution Set</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70305</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:08.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>8053617720320ZM</udiDi>
    <basicUdiDi>B-8053617720320ZM</basicUdiDi>
    <tradeName>Chemistry Multicalibrator</tradeName>
    <deviceName>Chemistry Multicalibrator</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL1010; CAL1013</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:21:44.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225323131CEKUSS</udiDi>
    <basicUdiDi>B-69750225323131CEKUSS</basicUdiDi>
    <tradeName>D-69750225323131CEKUSS</tradeName>
    <deviceName>Creatinine Control Solutions</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.5mL/vial，2 vials/box;4.0mL/vial，2 vials/box</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:15.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225321132CEK7Q5</udiDi>
    <basicUdiDi>B-69750225321132CEK7Q5</basicUdiDi>
    <tradeName>D-69750225321132CEK7Q5</tradeName>
    <deviceName>Total Cholesterol Control Solutions</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.5mL/vial，2 vials/box</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:12.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225321131CEK2PG</udiDi>
    <basicUdiDi>B-69750225321131CEK2PG</basicUdiDi>
    <tradeName>D-69750225321131CEK2PG</tradeName>
    <deviceName>Blood Gas Control Solutions</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050199</emdnCode>
    <emdnDescription>MULTICOMPONENT CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EG-c1, EG-c2, EG-c3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:11.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225319134CEN8V7</udiDi>
    <basicUdiDi>B-69750225319134CEN8V7</basicUdiDi>
    <tradeName>D-69750225319134CEN8V7</tradeName>
    <deviceName>Uric Acid Control Solutions</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.5mL/vial, 2 vials/box</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:57.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225319133CEN3UJ</udiDi>
    <basicUdiDi>B-69750225319133CEN3UJ</basicUdiDi>
    <tradeName>D-69750225319133CEN3UJ</tradeName>
    <deviceName>Lactate Control Solutions</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Specification 1 、Specification 2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:56.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225319131CEMRVM</udiDi>
    <basicUdiDi>B-69750225319131CEMRVM</basicUdiDi>
    <tradeName>D-69750225319131CEMRVM</tradeName>
    <deviceName>Blood Glucose Control Solutions</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Specification 1、Specification 2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:53.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225319132CEMWWA</udiDi>
    <basicUdiDi>B-69750225319132CEMWWA</basicUdiDi>
    <tradeName>D-69750225319132CEMWWA</tradeName>
    <deviceName>β-Ketone Control Solutions</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.5mL/vial, 2 vials/box</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:52.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-667740S7</udiDi>
    <basicUdiDi>B-667740S7</basicUdiDi>
    <tradeName>Ultimate-D Bilirubin Control Level 4</tradeName>
    <deviceName>Ultimate-D Bilirubin Control Level 4</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>W0101050203</emdnCode>
    <emdnDescription>BILIRUBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>667740</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:47:10.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-667730S4</udiDi>
    <basicUdiDi>B-667730S4</basicUdiDi>
    <tradeName>Ultimate-D Bilirubin Control Level 3</tradeName>
    <deviceName>Ultimate-D Bilirubin Control Level 3</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>W0101050203</emdnCode>
    <emdnDescription>BILIRUBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>667730</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:47:09.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-667720RZ</udiDi>
    <basicUdiDi>B-667720RZ</basicUdiDi>
    <tradeName>Ultimate-D Bilirubin Control Level 2</tradeName>
    <deviceName>Ultimate-D Bilirubin Control Level 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>W0101050203</emdnCode>
    <emdnDescription>BILIRUBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>667720</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:47:08.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-667710RW</udiDi>
    <basicUdiDi>B-667710RW</basicUdiDi>
    <tradeName>Ultimate-D Bilirubin Control Level 1</tradeName>
    <deviceName>Ultimate-D Bilirubin Control Level 1</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>W0101050203</emdnCode>
    <emdnDescription>BILIRUBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>667710</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:47:07.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-657365RQ</udiDi>
    <basicUdiDi>B-657365RQ</basicUdiDi>
    <tradeName>SYNCHRON Control Multilevel Comprehensive Chemistry Control Serum</tradeName>
    <deviceName>SYNCHRON Control Multilevel Comprehensive Chemistry Control Serum</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>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>657365</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:43:31.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6327F</udiDi>
    <basicUdiDi>B-6327F</basicUdiDi>
    <tradeName>D-6327F</tradeName>
    <deviceName>Urinary Control</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:41:04.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6297S</udiDi>
    <basicUdiDi>B-6297S</basicUdiDi>
    <tradeName>D-6297S</tradeName>
    <deviceName>Enzyme Multical Control</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:39:36.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6287Q</udiDi>
    <basicUdiDi>B-6287Q</basicUdiDi>
    <tradeName>D-6287Q</tradeName>
    <deviceName>Enzyme Multical Calibrator</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:39:13.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041034836</udiDi>
    <basicUdiDi>B-62230041034836</basicUdiDi>
    <tradeName>SP-Pathotrol</tradeName>
    <deviceName>SP-Pathotrol</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>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>327 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:27:31.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041034904</udiDi>
    <basicUdiDi>B-62230041034904</basicUdiDi>
    <tradeName>SP-Pathotrol</tradeName>
    <deviceName>SP-Pathotrol</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>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>327 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:27:27.551Z</lastUpdated>
  </row>
</eudamedExport>