<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-75471252Z</udiDi>
    <basicUdiDi>B-75471252Z</basicUdiDi>
    <tradeName>Coulter Retic-C Cell Control</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:52.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75471753G</udiDi>
    <basicUdiDi>B-75471753G</basicUdiDi>
    <tradeName>COULTER AcT 5dIff Calibrator</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547175</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:52.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75471873P</udiDi>
    <basicUdiDi>B-75471873P</basicUdiDi>
    <tradeName>COULTER 4C-ES Cell Control</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547187</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:52.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75471883R</udiDi>
    <basicUdiDi>B-75471883R</basicUdiDi>
    <tradeName>COULTER 4C-ES Cell Control</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547188</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:52.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75471893T</udiDi>
    <basicUdiDi>B-75471893T</basicUdiDi>
    <tradeName>COULTER 4C-ES Cell Control</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547189</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:52.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75471903C</udiDi>
    <basicUdiDi>B-75471903C</basicUdiDi>
    <tradeName>COULTER 4C-ES Cell Control</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547190</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:52.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75471983U</udiDi>
    <basicUdiDi>B-75471983U</basicUdiDi>
    <tradeName>COULTER Ac•T 5diff Control Plus</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547198</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:52.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75471993W</udiDi>
    <basicUdiDi>B-75471993W</basicUdiDi>
    <tradeName>Coulter 5C Cell Control</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547199</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:52.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75472022S</udiDi>
    <basicUdiDi>B-75472022S</basicUdiDi>
    <tradeName>COULTER 4C-ES Cell Control</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:51.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-969620TH</udiDi>
    <basicUdiDi>B-969620TH</basicUdiDi>
    <tradeName>SYNCHRON® C-Reactive Protein (C-RP) Reagent</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>969620</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:33:31.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-969650TS</udiDi>
    <basicUdiDi>B-969650TS</basicUdiDi>
    <tradeName>Pancreatic Amylase Reagent (PAM 2 x 60)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>969650</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:33:31.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-969706TU</udiDi>
    <basicUdiDi>B-969706TU</basicUdiDi>
    <tradeName>Direct LDL Cholesterol Reagent (LDLD 2 x 100)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>969706</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:33:31.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-988413TR</udiDi>
    <basicUdiDi>B-988413TR</basicUdiDi>
    <tradeName>Haptoglobin Reagent (HPT 2 x 100)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>988413</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:33:31.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-988462U6</udiDi>
    <basicUdiDi>B-988462U6</basicUdiDi>
    <tradeName>C3 Reagent (C3 2 x 100)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>988462</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:33:31.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-988471U7</udiDi>
    <basicUdiDi>B-988471U7</basicUdiDi>
    <tradeName>C4 Reagent (C4 2 x 100)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>988471</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:33:31.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A09426UC</udiDi>
    <basicUdiDi>B-A09426UC</basicUdiDi>
    <tradeName>Phosphorus Reagent (PHS 2 x300)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A09426</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:33:18.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A15625U3</udiDi>
    <basicUdiDi>B-A15625U3</basicUdiDi>
    <tradeName>HDL Cholesterol Reagent HDL 2 x 200</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A15625</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:33:18.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A18298UX</udiDi>
    <basicUdiDi>B-A18298UX</basicUdiDi>
    <tradeName>Benzodiazepine Reagent (BNZG 1 x 250)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18298</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:33:18.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A24291TY</udiDi>
    <basicUdiDi>B-A24291TY</basicUdiDi>
    <tradeName>Access HBs Ag</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A24291</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:33:18.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A24292U2</udiDi>
    <basicUdiDi>B-A24292U2</basicUdiDi>
    <tradeName>Access HBs Ag Calibrators</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A24292</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:33:18.002Z</lastUpdated>
  </row>
</eudamedExport>