<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-34435GJ</udiDi>
    <basicUdiDi>B-34435GJ</basicUdiDi>
    <tradeName>Access RUBELLA IgG Calibrators</tradeName>
    <deviceName>Access RUBELLA IgG Calibrators</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34435</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:56.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34255GE</udiDi>
    <basicUdiDi>B-34255GE</basicUdiDi>
    <tradeName>Access HBc IgM Calibrators</tradeName>
    <deviceName>Access HBc IgM Calibrators</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34255</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:52.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34249GK</udiDi>
    <basicUdiDi>B-34249GK</basicUdiDi>
    <tradeName>Access HBc Ab QC</tradeName>
    <deviceName>Access HBc Ab QC</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34249</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:37.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34245GB</udiDi>
    <basicUdiDi>B-34245GB</basicUdiDi>
    <tradeName>Access HBc Ab Calibrators</tradeName>
    <deviceName>Access HBc Ab Calibrators</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34245</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:36.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34215G2</udiDi>
    <basicUdiDi>B-34215G2</basicUdiDi>
    <tradeName>Access HAV IgM Calibrators</tradeName>
    <deviceName>Access HAV IgM Calibrators</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>34215</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:31.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34209G7</udiDi>
    <basicUdiDi>B-34209G7</basicUdiDi>
    <tradeName>HAV Ab QC</tradeName>
    <deviceName>HAV Ab QC</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>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34209</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:28.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34205FX</udiDi>
    <basicUdiDi>B-34205FX</basicUdiDi>
    <tradeName>HAV Ab Calibrators</tradeName>
    <deviceName>HAV Ab Calibrators</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>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34205</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:26.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33716GN</udiDi>
    <basicUdiDi>B-33716GN</basicUdiDi>
    <tradeName>Access Digoxin Calibrator S0</tradeName>
    <deviceName>Access Digoxin Calibrator S0</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>33716</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:38.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33715GL</udiDi>
    <basicUdiDi>B-33715GL</basicUdiDi>
    <tradeName>Access Digoxin Calibrators</tradeName>
    <deviceName>Access Digoxin Calibrators</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>33715</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:37.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33205FQ</udiDi>
    <basicUdiDi>B-33205FQ</basicUdiDi>
    <tradeName>Access CEA Calibrators</tradeName>
    <deviceName>Access CEA Calibrators</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>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33205</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:19.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3000-2338DK</udiDi>
    <basicUdiDi>B-3000-2338DK</basicUdiDi>
    <tradeName>sTfR (II) Calibrators</tradeName>
    <deviceName>sTfR (II) Calibrators</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152206</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000-2338</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:06:24.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153817366</udiDi>
    <basicUdiDi>B-16438153817366</basicUdiDi>
    <tradeName>16438153817366</tradeName>
    <deviceName>DoA Calibration set E</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981736</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:46:02.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153817311</udiDi>
    <basicUdiDi>B-16438153817311</basicUdiDi>
    <tradeName>16438153817311</tradeName>
    <deviceName>DoA Calibrator C3</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981731</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:46:01.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153817304</udiDi>
    <basicUdiDi>B-16438153817304</basicUdiDi>
    <tradeName>16438153817304</tradeName>
    <deviceName>DoA Calibrator C2</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981730</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:56.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153817298</udiDi>
    <basicUdiDi>B-16438153817298</basicUdiDi>
    <tradeName>16438153817298</tradeName>
    <deviceName>DoA Calibrator C1</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981729</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:55.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153817274</udiDi>
    <basicUdiDi>B-16438153817274</basicUdiDi>
    <tradeName>16438153817274</tradeName>
    <deviceName>DoA Calibrator B4</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981727</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:53.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153817267</udiDi>
    <basicUdiDi>B-16438153817267</basicUdiDi>
    <tradeName>16438153817267</tradeName>
    <deviceName>DoA Calibrator B3</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981726</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:48.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153817250</udiDi>
    <basicUdiDi>B-16438153817250</basicUdiDi>
    <tradeName>16438153817250</tradeName>
    <deviceName>DoA Calibrator B2</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981725</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:47.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153817243</udiDi>
    <basicUdiDi>B-16438153817243</basicUdiDi>
    <tradeName>16438153817243</tradeName>
    <deviceName>DoA Calibrator B1</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981724</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:46.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153817229</udiDi>
    <basicUdiDi>B-16438153817229</basicUdiDi>
    <tradeName>16438153817229</tradeName>
    <deviceName>DoA Calibrator A2</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981722</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:29.687Z</lastUpdated>
  </row>
</eudamedExport>