<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-472110PE</udiDi>
    <basicUdiDi>B-472110PE</basicUdiDi>
    <tradeName>SYNCHRON Systems 40 ng/mL THC Urine Control</tradeName>
    <deviceName>SYNCHRON Systems 40 ng/mL THC Urine Control</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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>472110</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:43.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-472107PR</udiDi>
    <basicUdiDi>B-472107PR</basicUdiDi>
    <tradeName>SYNCHRON Systems 10 ng/mL THC Urine Control</tradeName>
    <deviceName>SYNCHRON Systems 10 ng/mL THC Urine Control</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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>472107</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:42.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-469945SF</udiDi>
    <basicUdiDi>B-469945SF</basicUdiDi>
    <tradeName>SYNCHRON Systems DAT Drug Free Urine Control</tradeName>
    <deviceName>SYNCHRON Systems DAT Drug Free Urine Control</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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>469945</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:33.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-465912R4</udiDi>
    <basicUdiDi>B-465912R4</basicUdiDi>
    <tradeName>SYNCHRON Systems 75 ng/mL THC Urine Control</tradeName>
    <deviceName>SYNCHRON Systems 75 ng/mL THC Urine Control</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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>465912</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:52:24.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-465300PX</udiDi>
    <basicUdiDi>B-465300PX</basicUdiDi>
    <tradeName>Immunochemistry Systems Level 2 Urine Protein Control</tradeName>
    <deviceName>Immunochemistry Systems Level 2 Urine Protein Control</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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>465300</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:52:17.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-465290QM</udiDi>
    <basicUdiDi>B-465290QM</basicUdiDi>
    <tradeName>Immunochemistry Systems Level 1 Urine Protein Control</tradeName>
    <deviceName>Immunochemistry Systems Level 1 Urine Protein Control</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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>465290</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:52:16.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-450164NZ</udiDi>
    <basicUdiDi>B-450164NZ</basicUdiDi>
    <tradeName>Vigil Serology Control Level 3</tradeName>
    <deviceName>Vigil Serology 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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>450164</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:48:20.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-450163NX</udiDi>
    <basicUdiDi>B-450163NX</basicUdiDi>
    <tradeName>Vigil Serology Control Level 2</tradeName>
    <deviceName>Vigil Serology 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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>450163</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:48:16.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-450162NV</udiDi>
    <basicUdiDi>B-450162NV</basicUdiDi>
    <tradeName>Vigil Serology Control Level 1</tradeName>
    <deviceName>Vigil Serology 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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>450162</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:48:15.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-450130NG</udiDi>
    <basicUdiDi>B-450130NG</basicUdiDi>
    <tradeName>Vigil Protein Control Level 3</tradeName>
    <deviceName>Vigil Protein 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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>450130</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:48:14.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34479H6</udiDi>
    <basicUdiDi>B-34479H6</basicUdiDi>
    <tradeName>Access Toxo IgM II QC</tradeName>
    <deviceName>Access Toxo IgM II 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 B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34479</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:28:09.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34219GA</udiDi>
    <basicUdiDi>B-34219GA</basicUdiDi>
    <tradeName>Access HAV IgM QC</tradeName>
    <deviceName>Access HAV IgM 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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34219</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:32.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>25060527730155</udiDi>
    <basicUdiDi>B-25060527730155</basicUdiDi>
    <tradeName>PATHTROL™ TRYPTASE HIGH POSITIVE CONTROL</tradeName>
    <deviceName>PATHTROL™ TRYPTASE HIGH POSITIVE CONTROL</deviceName>
    <manufacturerName>Eurobio Scientific UK Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000053721</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PW85201</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:42:08.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>25060527730148</udiDi>
    <basicUdiDi>B-25060527730148</basicUdiDi>
    <tradeName>PATHTROL™ TRYPTASE POSITIVE CONTROL</tradeName>
    <deviceName>PATHTROL™ TRYPTASE POSITIVE CONTROL</deviceName>
    <manufacturerName>Eurobio Scientific UK Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000053721</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PW85101</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:42:04.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060527730158</udiDi>
    <basicUdiDi>B-15060527730158</basicUdiDi>
    <tradeName>PATHTROL™ TRYPTASE HIGH POSITIVE CONTROL</tradeName>
    <deviceName>PATHTROL™ TRYPTASE HIGH POSITIVE CONTROL</deviceName>
    <manufacturerName>Eurobio Scientific UK Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000053721</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PW85205</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:32:13.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060527730141</udiDi>
    <basicUdiDi>B-15060527730141</basicUdiDi>
    <tradeName>PATHTROL™ TRYPTASE POSITIVE CONTROL</tradeName>
    <deviceName>PATHTROL™ TRYPTASE POSITIVE CONTROL</deviceName>
    <manufacturerName>Eurobio Scientific UK Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000053721</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PW85105</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:32:12.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060527730103</udiDi>
    <basicUdiDi>B-15060527730103</basicUdiDi>
    <tradeName>PATHTROL™ ALLERGY CONTROL LEVEL 1 &amp; 2 (TRIAL PACK)</tradeName>
    <deviceName>PATHTROL™ ALLERGY CONTROL LEVEL 1 &amp; 2 (TRIAL PACK)</deviceName>
    <manufacturerName>Eurobio Scientific UK Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000053721</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PW80121</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:32:11.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060527730097</udiDi>
    <basicUdiDi>B-15060527730097</basicUdiDi>
    <tradeName>PathTROL Allergy Control - Level 2</tradeName>
    <deviceName>PATHTROL™ ALLERGY CONTROL - LEVEL 2</deviceName>
    <manufacturerName>Eurobio Scientific UK Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000053721</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PW80201</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:32:07.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060527730080</udiDi>
    <basicUdiDi>B-15060527730080</basicUdiDi>
    <tradeName>PathTROL Allergy Control - Level 1</tradeName>
    <deviceName>PathTROL™ Allergy Control – Level 1</deviceName>
    <manufacturerName>Eurobio Scientific UK Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000053721</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PW80101</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:32:07.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359522663</udiDi>
    <basicUdiDi>697015090000130GW</basicUdiDi>
    <tradeName>Thyroid Speciality Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZK0501L206</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:47:21.368Z</lastUpdated>
  </row>
</eudamedExport>