<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>14562185380139</udiDi>
    <basicUdiDi>543000049500019550LS4</basicUdiDi>
    <tradeName>HSi Hemolysis &amp; Wash Solution-(LL)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tosoh Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000000210</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>019550L</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:12:46.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562185380095</udiDi>
    <basicUdiDi>5430000495000960474SA</basicUdiDi>
    <tradeName>AIA-PACK MULTI ANALYTE CONTROL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tosoh Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000000210</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0960474</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:08:32.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562185380071</udiDi>
    <basicUdiDi>5430000495000968780UC</basicUdiDi>
    <tradeName>Hemolysis Collection System 10 µL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tosoh Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000000210</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0968780</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:08:31.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562185380040</udiDi>
    <basicUdiDi>5430000495000968700TL</basicUdiDi>
    <tradeName>Hemolysis Stability Solution 6 x 100 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tosoh Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000000210</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0968700</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:08:30.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562185380033</udiDi>
    <basicUdiDi>5430000495000020955MW</basicUdiDi>
    <tradeName>AIA-PACK WASH CONCENTRATE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tosoh Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000000210</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020955</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:08:29.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562185380026</udiDi>
    <basicUdiDi>5430000495000020956MY</basicUdiDi>
    <tradeName>AIA-PACK DILUENT CONCENTRATE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tosoh Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000000210</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020956</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:08:28.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562185380019</udiDi>
    <basicUdiDi>543000049500018431LRB</basicUdiDi>
    <tradeName>HSi Hemolysis &amp; Wash Solution-(L)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tosoh Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000000210</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018431L</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:08:27.552Z</lastUpdated>
  </row>
</eudamedExport>