<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975039130094</udiDi>
    <basicUdiDi>B-06975039130094</basicUdiDi>
    <tradeName>High Intensity Focused Ultrasound System</tradeName>
    <deviceName>High Intensity Focused Ultrasound System</deviceName>
    <manufacturerName>Shenzhen PRO HITU Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021578</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDD2022MA3375</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:58.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975039130018</udiDi>
    <basicUdiDi>B-06975039130018</basicUdiDi>
    <tradeName>NO</tradeName>
    <deviceName>High intensity focused ultrasound systems</deviceName>
    <manufacturerName>Shenzhen PRO HITU Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021578</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRO300</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:57.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975039130001</udiDi>
    <basicUdiDi>B-06975039130001</basicUdiDi>
    <tradeName>NO</tradeName>
    <deviceName>High intensity focused ultrasound systems</deviceName>
    <manufacturerName>Shenzhen PRO HITU Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021578</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRO2008</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:57.110Z</lastUpdated>
  </row>
</eudamedExport>