<?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>
  <row>
    <udiDi>00860007903403</udiDi>
    <basicUdiDi>B-00860007903403</basicUdiDi>
    <tradeName>RheOx Generator</tradeName>
    <deviceName>RheOx Generator</deviceName>
    <manufacturerName>Galvanize Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012701</manufacturerSrn>
    <authorisedRepresentativeName>Galvanize Therapeutics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000035678</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0199</emdnCode>
    <emdnDescription>ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GTI-00006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:07.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850033727012</udiDi>
    <basicUdiDi>0850033727GTI-00021-01HW</basicUdiDi>
    <tradeName>CENTAURI Generator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galvanize Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012701</manufacturerSrn>
    <authorisedRepresentativeName>Galvanize Therapeutics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000035678</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GTI-00021-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:17.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850033727029</udiDi>
    <basicUdiDi>0850033727GTI-00022-03J9</basicUdiDi>
    <tradeName>CENTAURI Connect</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galvanize Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012701</manufacturerSrn>
    <authorisedRepresentativeName>Galvanize Therapeutics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000035678</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GTI-00022-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:17.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850033727043</udiDi>
    <basicUdiDi>0850033727GTI-00038BC</basicUdiDi>
    <tradeName>Compatibility Cable, BW ThermoCool ST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galvanize Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012701</manufacturerSrn>
    <authorisedRepresentativeName>Galvanize Therapeutics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000035678</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GTI-00038</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:17.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850033727050</udiDi>
    <basicUdiDi>0850033727GTI-00045B9</basicUdiDi>
    <tradeName>ECG Trunk Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galvanize Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012701</manufacturerSrn>
    <authorisedRepresentativeName>Galvanize Therapeutics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000035678</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GTI-00045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:17.739Z</lastUpdated>
  </row>
</eudamedExport>