<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00860007903427</udiDi>
    <basicUdiDi>B-00860007903427</basicUdiDi>
    <tradeName>RheOx Catheter</tradeName>
    <deviceName>RheOx Catheter</deviceName>
    <manufacturerName>Galvanize Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012701</manufacturerSrn>
    <authorisedRepresentativeName>Galvanize Therapeutics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000035678</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R070180</emdnCode>
    <emdnDescription>BRONCHOPULMONARY ENDOSCOPY PROBES, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GTI-00005-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:12.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860007903410</udiDi>
    <basicUdiDi>B-00860007903410</basicUdiDi>
    <tradeName>RheOx Catheter</tradeName>
    <deviceName>RheOx Catheter</deviceName>
    <manufacturerName>Galvanize Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012701</manufacturerSrn>
    <authorisedRepresentativeName>Galvanize Therapeutics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000035678</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R070180</emdnCode>
    <emdnDescription>BRONCHOPULMONARY ENDOSCOPY PROBES, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GTI-00005-02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:11.631Z</lastUpdated>
  </row>
</eudamedExport>