<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00868643000401</udiDi>
    <basicUdiDi>086864300040CK</basicUdiDi>
    <tradeName>IRRAflow Control Unit 4.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IRRAS USA Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011820</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICCU 020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:38:39.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>00868643000432</udiDi>
    <basicUdiDi>B-00868643000432</basicUdiDi>
    <tradeName>IRRAflow Catheter 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IRRAS USA Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011820</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICGS 020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:37:48.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>00868643000418</udiDi>
    <basicUdiDi>B-00868643000418</basicUdiDi>
    <tradeName>IRRAflow Tube Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IRRAS USA Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011820</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICDS 020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:37:48.474Z</lastUpdated>
  </row>
</eudamedExport>