<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00815762020230</udiDi>
    <basicUdiDi>B-00815762020230</basicUdiDi>
    <tradeName>CBC-3D for Abacus Hematology Control</tradeName>
    <deviceName>CBC-3D1</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D3D02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:20:50.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815762020209</udiDi>
    <basicUdiDi>B-00815762020209</basicUdiDi>
    <tradeName>CBC-3D Hematology Control</tradeName>
    <deviceName>CBC-3D1</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D516</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:20:49.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815762020186</udiDi>
    <basicUdiDi>B-00815762020186</basicUdiDi>
    <tradeName>CBC-3D Hematology Control</tradeName>
    <deviceName>CBC-3D1</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D508</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:20:48.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815762020179</udiDi>
    <basicUdiDi>B-00815762020179</basicUdiDi>
    <tradeName>CBC-3D Hematology Control</tradeName>
    <deviceName>CBC-3D1</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D507</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:20:32.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815762020162</udiDi>
    <basicUdiDi>B-00815762020162</basicUdiDi>
    <tradeName>CBC-3D Hematology Control</tradeName>
    <deviceName>CBC-3D1</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D506US</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:20:31.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815762020124</udiDi>
    <basicUdiDi>B-00815762020124</basicUdiDi>
    <tradeName>CBC-3D Hematology Control</tradeName>
    <deviceName>CBC-3D1</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D503RX</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:20:27.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815762020117</udiDi>
    <basicUdiDi>B-00815762020117</basicUdiDi>
    <tradeName>CBC-3D Hematology Control</tradeName>
    <deviceName>CBC-3D1</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D503</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:20:26.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815762020100</udiDi>
    <basicUdiDi>B-00815762020100</basicUdiDi>
    <tradeName>CBC-3D Hematology Control</tradeName>
    <deviceName>CBC-3D1</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D502</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:20:26.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844509000655</udiDi>
    <basicUdiDi>0844509012EXT5Y</basicUdiDi>
    <tradeName>Streck</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Streck</manufacturerName>
    <manufacturerSrn>US-MF-000013009</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>218775</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:14.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844509000662</udiDi>
    <basicUdiDi>0844509012EXT5Y</basicUdiDi>
    <tradeName>Streck</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Streck</manufacturerName>
    <manufacturerSrn>US-MF-000013009</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>218770</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:14.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844509000679</udiDi>
    <basicUdiDi>0844509012EXT5Y</basicUdiDi>
    <tradeName>Streck</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Streck</manufacturerName>
    <manufacturerSrn>US-MF-000013009</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>218776</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:14.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590233778</udiDi>
    <basicUdiDi>150995901HEMCONTROL9R</basicUdiDi>
    <tradeName>COULTER</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 Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>628027</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:13:30.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590233785</udiDi>
    <basicUdiDi>150995901HEMCONTROL9R</basicUdiDi>
    <tradeName>COULTER</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 Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>628028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:13:30.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590233808</udiDi>
    <basicUdiDi>150995901HEMCONTROL9R</basicUdiDi>
    <tradeName>COULTER</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 Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>628030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:13:30.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008522</udiDi>
    <basicUdiDi>361023minotrol16BH</basicUdiDi>
    <tradeName>ABX Minotrol 16</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1212042202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:02.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008539</udiDi>
    <basicUdiDi>361023minotrol16BH</basicUdiDi>
    <tradeName>ABX Minotrol 16</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1212042209</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:02.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008553</udiDi>
    <basicUdiDi>361023difftrolXR</basicUdiDi>
    <tradeName>ABX Difftrol</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2062203</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:02.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008560</udiDi>
    <basicUdiDi>361023difftrolXR</basicUdiDi>
    <tradeName>ABX Difftrol</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2062208</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:02.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009659</udiDi>
    <basicUdiDi>361023minotrol16BH</basicUdiDi>
    <tradeName>ABX Minotrol 16</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300135996</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:01.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009666</udiDi>
    <basicUdiDi>361023minotrol16BH</basicUdiDi>
    <tradeName>ABX Minotrol 16</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300135997</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:01.411Z</lastUpdated>
  </row>
</eudamedExport>