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<eudamedExport entity="devices">
  <row>
    <udiDi>15099590010775</udiDi>
    <basicUdiDi>150995902OSR6182N2</basicUdiDi>
    <tradeName>Alpha-amylase</tradeName>
    <deviceName>Alpha-amylase</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6182</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:29:01.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010744</udiDi>
    <basicUdiDi>150995901OSR6179MS</basicUdiDi>
    <tradeName>Creatine Kinase (CK NAC)</tradeName>
    <deviceName>Creatine Kinase (CK NAC)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6179</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:59.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010737</udiDi>
    <basicUdiDi>150995901OSR6178MQ</basicUdiDi>
    <tradeName>Creatinine</tradeName>
    <deviceName>Creatinine</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6178</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:57.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010676</udiDi>
    <basicUdiDi>150995901OSR6170M8</basicUdiDi>
    <tradeName>Urinary/CSF Protein</tradeName>
    <deviceName>Urinary/CSF Protein</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6170</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:55.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010386</udiDi>
    <basicUdiDi>150995901OSR6141LZ</basicUdiDi>
    <tradeName>Urea STAT</tradeName>
    <deviceName>Urea STAT</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6141</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:20.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010317</udiDi>
    <basicUdiDi>150995901OSR6134M4</basicUdiDi>
    <tradeName>Urea</tradeName>
    <deviceName>Urea</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6134</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:15.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010294</udiDi>
    <basicUdiDi>150995901OSR6132LY</basicUdiDi>
    <tradeName>Total Protein</tradeName>
    <deviceName>Total Protein</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6132</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:15.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010270</udiDi>
    <basicUdiDi>150995901OSR6130LU</basicUdiDi>
    <tradeName>Lipase</tradeName>
    <deviceName>Lipase</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010123</emdnCode>
    <emdnDescription>LIPASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6130</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:14.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010256</udiDi>
    <basicUdiDi>150995902OSR6128MU</basicUdiDi>
    <tradeName>LDH</tradeName>
    <deviceName>LDH</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010119</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE L  ( LDH - L --&gt; P )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6128</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:13.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010232</udiDi>
    <basicUdiDi>150995902OSR6126MQ</basicUdiDi>
    <tradeName>LDH</tradeName>
    <deviceName>LDH</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010119</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE L  ( LDH - L --&gt; P )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6126</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:09.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010201</udiDi>
    <basicUdiDi>150995901OSR6122LV</basicUdiDi>
    <tradeName>Inorganic Phosphorous</tradeName>
    <deviceName>Inorganic Phosphorous</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6122</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:08.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010188</udiDi>
    <basicUdiDi>150995902OSR6120MC</basicUdiDi>
    <tradeName>GGT</tradeName>
    <deviceName>GGT</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010116</emdnCode>
    <emdnDescription>GAMMA GLUTAMYLTRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:07.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010140</udiDi>
    <basicUdiDi>150995901OSR6116M2</basicUdiDi>
    <tradeName>Cholesterol</tradeName>
    <deviceName>Cholesterol</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6116</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:07.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010133</udiDi>
    <basicUdiDi>150995901OSR6114LW</basicUdiDi>
    <tradeName>Cholinesterase</tradeName>
    <deviceName>Cholinesterase</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010111</emdnCode>
    <emdnDescription>CHOLINESTERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6114</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:03.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010126</udiDi>
    <basicUdiDi>150995901OSR6113LU</basicUdiDi>
    <tradeName>Calcium oCPC</tradeName>
    <deviceName>Calcium oCPC</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6113</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:02.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010119</udiDi>
    <basicUdiDi>150995901OSR6112LS</basicUdiDi>
    <tradeName>Total Bilirubin</tradeName>
    <deviceName>Total Bilirubin</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6112</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:00.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010102</udiDi>
    <basicUdiDi>150995901OSR6111LQ</basicUdiDi>
    <tradeName>Direct Bilirubin</tradeName>
    <deviceName>Direct Bilirubin</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6111</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:27:59.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010089</udiDi>
    <basicUdiDi>150995901OSR6109M5</basicUdiDi>
    <tradeName>AST</tradeName>
    <deviceName>AST</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010110</emdnCode>
    <emdnDescription>ASPARTATE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6109</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:27:55.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010065</udiDi>
    <basicUdiDi>150995901OSR6107LZ</basicUdiDi>
    <tradeName>ALT</tradeName>
    <deviceName>ALT</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010103</emdnCode>
    <emdnDescription>ALANINE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6107</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:27:55.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590010058</udiDi>
    <basicUdiDi>150995901OSR6106LX</basicUdiDi>
    <tradeName>α-AMYLASE</tradeName>
    <deviceName>α-AMYLASE</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6106</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:27:54.249Z</lastUpdated>
  </row>
</eudamedExport>