<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00843685100005</udiDi>
    <basicUdiDi>08436851NKV550K7</basicUdiDi>
    <tradeName>Nihon Kohden NKV-550 Series Ventilator System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nihon Kohden OrangeMed, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019023</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKV-550-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:40:10.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843685100012</udiDi>
    <basicUdiDi>08436851NKV550K7</basicUdiDi>
    <tradeName>Nihon Kohden NKV-550 Series Ventilator System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nihon Kohden OrangeMed, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019023</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKV-550-U</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:40:10.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843685100029</udiDi>
    <basicUdiDi>08436851NKV550K7</basicUdiDi>
    <tradeName>Nihon Kohden NKV-550 Series Ventilator System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nihon Kohden OrangeMed, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019023</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKV-550-N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:40:10.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843685100159</udiDi>
    <basicUdiDi>08436851NKV440JX</basicUdiDi>
    <tradeName>Nihon Kohden NKV-440 Ventilator System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nihon Kohden OrangeMed, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019023</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKV-440</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:40:10.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843685100166</udiDi>
    <basicUdiDi>08436851NKV440JX</basicUdiDi>
    <tradeName>Nihon Kohden NKV-440 Ventilator System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nihon Kohden OrangeMed, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019023</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKV-440</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:40:10.665Z</lastUpdated>
  </row>
</eudamedExport>