<?xml version="1.0" encoding="UTF-8"?>
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    <udiDi>07350040635193</udiDi>
    <basicUdiDi>7350040638R117RJ</basicUdiDi>
    <tradeName>Devyser Thalassemia v2</tradeName>
    <deviceName>Devyser Thalassemia v2</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R117-24</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:48:23.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341680459</udiDi>
    <basicUdiDi>69703416803202027HS</basicUdiDi>
    <tradeName>ß-THALASSAEMIA &amp; HbA1c Reagent Kit (HPLC)</tradeName>
    <deviceName>ß-THALASSAEMIA &amp; HbA1c Reagent Kit (HPLC)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320201205</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:53:11.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731097</udiDi>
    <basicUdiDi>B-06955792731097</basicUdiDi>
    <tradeName>06955792731097</tradeName>
    <deviceName>α-Thalassemia Gene Diagnostic Kit(gap-PCR)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S3045E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:29:57.316Z</lastUpdated>
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