<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05391517938272</udiDi>
    <basicUdiDi>539151793AG00016WP</basicUdiDi>
    <tradeName>Aerogen CNTS Tube Set (10 pack)</tradeName>
    <deviceName>Aerogen CNTS Tube Set</deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-AS3170</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:08.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517938265</udiDi>
    <basicUdiDi>539151793AG00015WM</basicUdiDi>
    <tradeName>Aerogen Solo CNTS Syringe &amp; Cap(20 Pack)</tradeName>
    <deviceName>Aerogen Solo CNTS Syringe &amp; Cap</deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-AS3180</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:08.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517938241</udiDi>
    <basicUdiDi>539151793AG00012WF</basicUdiDi>
    <tradeName>Aerogen Ultra Oxygen Tubing 10-Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-AS7008-EUR</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:07.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937985</udiDi>
    <basicUdiDi>539151793AG00008WQ</basicUdiDi>
    <tradeName>Aerogen USB Controller AC/DC Adapter (EU)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-UC1040-EU</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:06.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937886</udiDi>
    <basicUdiDi>539151793AG00020WE</basicUdiDi>
    <tradeName>Aerogen Ultra with I-Guard™ Aerosol Mask (Adult)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-AS7001-EUR</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:05.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937879</udiDi>
    <basicUdiDi>539151793AG00013WH</basicUdiDi>
    <tradeName>Aerogen Ultra-10 PK</tradeName>
    <deviceName>Aerogen Ultra</deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-AS7000-EUR</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:04.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937855</udiDi>
    <basicUdiDi>539151793AG00011WD</basicUdiDi>
    <tradeName>Aerogen Solo T-Piece Plug</tradeName>
    <deviceName>Aerogen Solo T-Piece Plug</deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-AS3450</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:04.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937831</udiDi>
    <basicUdiDi>539151793AG00019WV</basicUdiDi>
    <tradeName>Aerogen Solo Convenience Kit (5 Pack)</tradeName>
    <deviceName>Aerogen Solo Convenience Kit (5 Pack)</deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-AS3300</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:03.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937800</udiDi>
    <basicUdiDi>539151793AG00003WE</basicUdiDi>
    <tradeName>Aerogen USB Controller</tradeName>
    <deviceName>Aerogen USB Controller</deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-UC1000-SE</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:01.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937794</udiDi>
    <basicUdiDi>539151793AG00009WS</basicUdiDi>
    <tradeName>Aerogen Solo Nebuliser (5 Pack)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-AS3100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:00.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937749</udiDi>
    <basicUdiDi>539151793AG00010WB</basicUdiDi>
    <tradeName>Aerogen Solo T-Piece 22mm</tradeName>
    <deviceName>Aerogen Solo T-Piece</deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-AS3010</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:00.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517938258</udiDi>
    <basicUdiDi>539151793AG00013WH</basicUdiDi>
    <tradeName>Aerogen Ultra Mouthpiece 10 Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-AS7003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:33:20.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937992</udiDi>
    <basicUdiDi>539151793AG00008WQ</basicUdiDi>
    <tradeName>Aerogen USB Controller AC/DC Adapter (UK)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-UC1040-UK</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:35:48.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937978</udiDi>
    <basicUdiDi>539151793AG00003WE</basicUdiDi>
    <tradeName>Aerogen USB Controller</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-UC1000-UK</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:35:47.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937961</udiDi>
    <basicUdiDi>539151793AG00003WE</basicUdiDi>
    <tradeName>Aerogen USB Controller</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-UC1000-NE</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:35:46.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937954</udiDi>
    <basicUdiDi>539151793AG00003WE</basicUdiDi>
    <tradeName>Aerogen USB Controller</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-UC1000-SC</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:35:45.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937947</udiDi>
    <basicUdiDi>539151793AG00003WE</basicUdiDi>
    <tradeName>Aerogen USB Controller</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-UC1000-RB</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:35:44.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937923</udiDi>
    <basicUdiDi>539151793AG00003WE</basicUdiDi>
    <tradeName>Aerogen USB Controller</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-UC1000-CE</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:35:43.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937916</udiDi>
    <basicUdiDi>539151793AG00020WE</basicUdiDi>
    <tradeName>Aerogen Ultra Starter Kit Ped Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-AS7502-EUR</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:35:42.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391517937909</udiDi>
    <basicUdiDi>539151793AG00020WE</basicUdiDi>
    <tradeName>Aerogen Ultra Starter Kit Adult Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerogen Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000004597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-AS7501-EUR</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:35:41.796Z</lastUpdated>
  </row>
</eudamedExport>