<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00860014024832</udiDi>
    <basicUdiDi>B-00860014024832</basicUdiDi>
    <tradeName>Revivent TC</tradeName>
    <deviceName>Introducer Kit BVX-150RTC</deviceName>
    <manufacturerName>BioVentrix Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044097</manufacturerSrn>
    <authorisedRepresentativeName>Meditrial Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007805</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J010399</emdnCode>
    <emdnDescription>IMPLANTABLE VENTRICULAR ASSISTANCE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVX-150RTC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:48.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860014024818</udiDi>
    <basicUdiDi>B-00860014024818</basicUdiDi>
    <tradeName>Revivent TC</tradeName>
    <deviceName>LV-LV Anchor Kit, Curved Needle-20 BVX-120RTC</deviceName>
    <manufacturerName>BioVentrix Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044097</manufacturerSrn>
    <authorisedRepresentativeName>Meditrial Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007805</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J010399</emdnCode>
    <emdnDescription>IMPLANTABLE VENTRICULAR ASSISTANCE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVX-120RTC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:46.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860014024801</udiDi>
    <basicUdiDi>B-00860014024801</basicUdiDi>
    <tradeName>Revivent TC</tradeName>
    <deviceName>Anchor Kit, Flex BVX-110RTC</deviceName>
    <manufacturerName>BioVentrix Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044097</manufacturerSrn>
    <authorisedRepresentativeName>Meditrial Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007805</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J010399</emdnCode>
    <emdnDescription>IMPLANTABLE VENTRICULAR ASSISTANCE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVX-110RTC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:46.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860014024825</udiDi>
    <basicUdiDi>B-00860014024825</basicUdiDi>
    <tradeName>Revivent TC</tradeName>
    <deviceName>TransThoracic Force Gauge BVX-145RTC</deviceName>
    <manufacturerName>BioVentrix Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044097</manufacturerSrn>
    <authorisedRepresentativeName>Meditrial Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007805</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J010399</emdnCode>
    <emdnDescription>IMPLANTABLE VENTRICULAR ASSISTANCE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVX-145RTC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:44.602Z</lastUpdated>
  </row>
</eudamedExport>