<?xml version="1.0" encoding="UTF-8"?>
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    <udiDi>06979497340071</udiDi>
    <basicUdiDi>697949734FACA01RM</basicUdiDi>
    <tradeName>06979497340071</tradeName>
    <deviceName>Fully automatic coagulation analyzer</deviceName>
    <manufacturerName>Jiangsu Hongen Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051431</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H1201</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:45:17.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979497340019</udiDi>
    <basicUdiDi>697949734FADESRA0139</basicUdiDi>
    <tradeName>06979497340019</tradeName>
    <deviceName>Fully automatic dynamic erythrocyte sedimentation rate analyzer</deviceName>
    <manufacturerName>Jiangsu Hongen Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051431</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HXC-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:45:16.838Z</lastUpdated>
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