<?xml version="1.0" encoding="UTF-8"?>
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    <udiDi>00195278483713</udiDi>
    <basicUdiDi>8406821BUG00299J3</basicUdiDi>
    <tradeName>SIGNA 7.0T</tradeName>
    <deviceName>SIGNA 7.0T</deviceName>
    <manufacturerName>GE Medical Systems LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001632</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050106</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 4T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIGNA 7.0T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:27:03.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576830435</udiDi>
    <basicUdiDi>697157683043N6</basicUdiDi>
    <tradeName>06971576830435</tradeName>
    <deviceName>Magnetic Resonance Imaging System</deviceName>
    <manufacturerName>Shanghai United Imaging Healthcare Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008501</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050106</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 4T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000220</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:20.860Z</lastUpdated>
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