<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974929820008</udiDi>
    <basicUdiDi>697492982SPM2J</basicUdiDi>
    <tradeName>Spectrumedics</tradeName>
    <deviceName>Intravascular Lithotripsy Generator</deviceName>
    <manufacturerName>Spectrumedics Medical Technology (Shanghai) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046123</manufacturerSrn>
    <authorisedRepresentativeName>BioDomi GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016611</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010499</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPM-2400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:44:11.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974929820015</udiDi>
    <basicUdiDi>697492982SPM2J</basicUdiDi>
    <tradeName>Spectrumedics</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spectrumedics Medical Technology (Shanghai) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046123</manufacturerSrn>
    <authorisedRepresentativeName>BioDomi GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016611</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010499</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPM-3500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:45:02.178Z</lastUpdated>
  </row>
</eudamedExport>