<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>06978507780340</udiDi>
    <basicUdiDi>697850778BIA10MF</basicUdiDi>
    <tradeName>Fully Auto Biochemistry Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Infitek Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048840</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA-A-200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:37:45.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>89061707100964</udiDi>
    <basicUdiDi>890617071AVCCADW</basicUdiDi>
    <tradeName>MAXLYZER SMART PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Avecon Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000040691</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVCCA 02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:30:31.754Z</lastUpdated>
  </row>
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