<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987562510948</udiDi>
    <basicUdiDi>4987562SULFOLYSERBV</basicUdiDi>
    <tradeName>SULFOLYSER</tradeName>
    <deviceName>SULFOLYSER</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>904-1141-4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:41:54.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HC-111ELTP</udiDi>
    <basicUdiDi>B-HC-111ELTP</basicUdiDi>
    <tradeName>D-HC-111ELTP</tradeName>
    <deviceName>Hemoglobin A2 elevated control</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HC-111EL</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:53:07.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HC-102ZU</udiDi>
    <basicUdiDi>B-HC-102ZU</basicUdiDi>
    <tradeName>D-HC-102ZU</tradeName>
    <deviceName>AFSC Haemoglobin control</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HC-102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:53:06.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HC-111ZV</udiDi>
    <basicUdiDi>B-HC-111ZV</basicUdiDi>
    <tradeName>D-HC-111ZV</tradeName>
    <deviceName>Hemoglobin A2 normal control</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HC-111</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:53:04.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AN01637A032A</udiDi>
    <basicUdiDi>B-AN01637A032A</basicUdiDi>
    <tradeName>HemoTrol Duo High</tradeName>
    <deviceName>HemoTrol Duo High</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN01637A03</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:35:57.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AN01637A0228</udiDi>
    <basicUdiDi>B-AN01637A0228</basicUdiDi>
    <tradeName>HemoTrol Duo Normal</tradeName>
    <deviceName>HemoTrol Duo Normal</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN01637A02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:35:56.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AN01637A0126</udiDi>
    <basicUdiDi>B-AN01637A0126</basicUdiDi>
    <tradeName>HemoTrol Duo Low</tradeName>
    <deviceName>HemoTrol Duo Low</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN01637A01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:35:41.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A88469XF</udiDi>
    <basicUdiDi>B-A88469XF</basicUdiDi>
    <tradeName>HbDIL DxC</tradeName>
    <deviceName>HbDIL DxC</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>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A88469</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:16:45.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-202.003.00265</udiDi>
    <basicUdiDi>B-202.003.00265</basicUdiDi>
    <tradeName>HemoTrol High (Level 3)</tradeName>
    <deviceName>HemoTrol High (Level 3)</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202.003.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:57.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-202.002.0025S</udiDi>
    <basicUdiDi>B-202.002.0025S</basicUdiDi>
    <tradeName>HemoTrol Normal (Level 2)</tradeName>
    <deviceName>HemoTrol Normal (Level 2)</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202.002.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:53.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-202.001.0025F</udiDi>
    <basicUdiDi>B-202.001.0025F</basicUdiDi>
    <tradeName>HemoTrol Low (Level 1)</tradeName>
    <deviceName>HemoTrol Low (Level 1)</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202.001.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:52.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-147.003.002CD</udiDi>
    <basicUdiDi>B-147.003.002CD</basicUdiDi>
    <tradeName>Hb 301 Control High</tradeName>
    <deviceName>Hb 301 Control High</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>147.003.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:18:11.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-147.002.002C2</udiDi>
    <basicUdiDi>B-147.002.002C2</basicUdiDi>
    <tradeName>Hb 301 Control Normal</tradeName>
    <deviceName>Hb 301 Control Normal</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>147.002.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:18:10.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-147.001.002BP</udiDi>
    <basicUdiDi>B-147.001.002BP</basicUdiDi>
    <tradeName>Hb 301 Control Low</tradeName>
    <deviceName>Hb 301 Control Low</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>147.001.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:18:09.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421902348044</udiDi>
    <basicUdiDi>B-09421902348044</basicUdiDi>
    <tradeName>extendSURETM Haemoglobin F and A2 Calibrators</tradeName>
    <deviceName>extendSURETM Haemoglobin F and A2 Calibrators</deviceName>
    <manufacturerName>Canterbury Scientific Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000001778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB110SCALAr</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:52.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421902348037</udiDi>
    <basicUdiDi>B-09421902348037</basicUdiDi>
    <tradeName>extendSURE™ Haemoglobin F and A2 Controls</tradeName>
    <deviceName>extendSURE™ Haemoglobin F and A2 Controls</deviceName>
    <manufacturerName>Canterbury Scientific Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000001778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB110SSBAr</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:50.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065170203</udiDi>
    <basicUdiDi>B-08800065170203</basicUdiDi>
    <tradeName>CERA-CHEK™  3 in 1 GHL Hemoglobin Control Solution</tradeName>
    <deviceName>Hemoglobin Control Solution</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M400C11</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:32.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065170005</udiDi>
    <basicUdiDi>B-08800065170005</basicUdiDi>
    <tradeName>CERA-CHEK™ Hb Plus Hemoglobin Control Solution</tradeName>
    <deviceName>CERA-CHEK™ Hb Plus Hemoglobin Control Solution</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B400C10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:32.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978467910214</udiDi>
    <basicUdiDi>B-06978467910214</basicUdiDi>
    <tradeName>AllDx</tradeName>
    <deviceName>Hb Hemoglobin Control Solution</deviceName>
    <manufacturerName>Hangzhou Aokai Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048311</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS105-0011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:44:15.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139078327</udiDi>
    <basicUdiDi>B-06978139078327</basicUdiDi>
    <tradeName>ß-THALASSAEMIA &amp; HbA1c Control Material</tradeName>
    <deviceName>ß-THALASSAEMIA &amp; HbA1c Control Material</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>56150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:11.592Z</lastUpdated>
  </row>
</eudamedExport>