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<eudamedExport entity="devices">
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    <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>
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  <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>
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  <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>
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    <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>
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  <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>
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  <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>
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  <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>
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  <row>
    <udiDi>05904800223414</udiDi>
    <basicUdiDi>59048002234kom_inhal88</basicUdiDi>
    <tradeName>Spiro Hospital</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WEGA Handel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020205</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Spiro Hospital</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:44:52.552Z</lastUpdated>
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  <row>
    <udiDi>05904800223421</udiDi>
    <basicUdiDi>59048002234kom_inhal88</basicUdiDi>
    <tradeName>Apteo Komora Inhalacyjna KI-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WEGA Handel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020205</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Apteo Komora Inhalacyjna KI-200</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:44:52.513Z</lastUpdated>
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  <row>
    <udiDi>04260652960268</udiDi>
    <basicUdiDi>426065296-P678-4060-00ZF</basicUdiDi>
    <tradeName>eFlow Controller</tradeName>
    <deviceName>eBase Controller</deviceName>
    <manufacturerName>PARI Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006193</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>678B4020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:54:23.548Z</lastUpdated>
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  <row>
    <udiDi>04066299860011</udiDi>
    <basicUdiDi>4066299SIH15XA</basicUdiDi>
    <tradeName>04066299860011</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Dinslage GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005488</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>86001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:48:06.035Z</lastUpdated>
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  <row>
    <udiDi>04015672114159</udiDi>
    <basicUdiDi>40156721141556</basicUdiDi>
    <tradeName>04015672114159</tradeName>
    <deviceName>CompAir Basic (NE-C106-KSA)</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NE-C106-KSA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:48:32.892Z</lastUpdated>
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  <row>
    <udiDi>04015672114128</udiDi>
    <basicUdiDi>4015672114124Y</basicUdiDi>
    <tradeName>04015672114128</tradeName>
    <deviceName>CompAir Basic (NE-C106-E)</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE-C106-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:48:31.312Z</lastUpdated>
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  <row>
    <udiDi>04015672114050</udiDi>
    <basicUdiDi>40156721140553</basicUdiDi>
    <tradeName>04015672114050</tradeName>
    <deviceName>NEB-TPC-8A (NEB-TPC-8AE)</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-TPC-8AE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:48:24.087Z</lastUpdated>
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    <udiDi>04015672114043</udiDi>
    <basicUdiDi>4015672114044Z</basicUdiDi>
    <tradeName>04015672114043</tradeName>
    <deviceName>NEB-NSETB-8A(NEB-NSETB-8AE)</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-NSETB-8AE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:48:22.502Z</lastUpdated>
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  <row>
    <udiDi>04015672114036</udiDi>
    <basicUdiDi>4015672114034X</basicUdiDi>
    <tradeName>NE-C810</tradeName>
    <deviceName>NE-C810</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE-C810-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:48:20.085Z</lastUpdated>
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    <udiDi>04015672113961</udiDi>
    <basicUdiDi>4015672113965T</basicUdiDi>
    <tradeName>Mouth Piece NE-U22</tradeName>
    <deviceName>Mouthpiece</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9520281-5</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:48:13.685Z</lastUpdated>
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    <udiDi>04015672113695</udiDi>
    <basicUdiDi>4015672113695Q</basicUdiDi>
    <tradeName>Air Tube (NEB-TP-82E)</tradeName>
    <deviceName>Air Tube</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-TP-82E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:48:09.684Z</lastUpdated>
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    <udiDi>04015672113688</udiDi>
    <basicUdiDi>4015672113685N</basicUdiDi>
    <tradeName>Air Tube (NEB-TP-L10E)</tradeName>
    <deviceName>Air Tube</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-TP-L10E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:48:07.279Z</lastUpdated>
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    <udiDi>04015672113664</udiDi>
    <basicUdiDi>4015672113665J</basicUdiDi>
    <tradeName>Mesh Cap (U22-4-E)</tradeName>
    <deviceName>Mesh Cap U22</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9518216-4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:48:05.681Z</lastUpdated>
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