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    <tradeName>Nebulizer Kit Set (NEB-NSET1-90E)</tradeName>
    <deviceName>NEB-NSET1-90E</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>9701325-4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:55.803Z</lastUpdated>
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    <udiDi>04015672109377</udiDi>
    <basicUdiDi>40156721093762</basicUdiDi>
    <tradeName>COMP AIR Basic (NE-C803-UK)</tradeName>
    <deviceName>COMP AIR Basic</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-C803-UK</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:54.201Z</lastUpdated>
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    <udiDi>04015672109353</udiDi>
    <basicUdiDi>4015672109355W</basicUdiDi>
    <tradeName>COMP AIR Basic (NE-C803-E)</tradeName>
    <deviceName>COMP AIR Basic</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-C803-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:38.147Z</lastUpdated>
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    <udiDi>04015672106604</udiDi>
    <basicUdiDi>4015672106605E</basicUdiDi>
    <tradeName>NE-C801 (NE-C801S-UK(V))</tradeName>
    <deviceName>NEB-NE-C801</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-C801S-UK(V)</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:10.140Z</lastUpdated>
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    <udiDi>04015672106499</udiDi>
    <basicUdiDi>4015672106495S</basicUdiDi>
    <tradeName>Comp A.I.R. Pro NE-C900 (NE-C900-E)</tradeName>
    <deviceName>Comp A.I.R. Pro NE-C900</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-C900-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:08.531Z</lastUpdated>
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    <udiDi>04015672105645</udiDi>
    <basicUdiDi>4015672105645H</basicUdiDi>
    <tradeName>NEB-NE-C801 (NE-C801S-E(V))</tradeName>
    <deviceName>NEB-NE-C801</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-C801S-E(V)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:07.726Z</lastUpdated>
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    <udiDi>04015672105621</udiDi>
    <basicUdiDi>4015672105625D</basicUdiDi>
    <tradeName>NEB-NE-C801KD (NE-C801S-KDE(V))</tradeName>
    <deviceName>NEB-NE-C801KD</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-C801S-KDE(V)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:06.128Z</lastUpdated>
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    <udiDi>04015672102422</udiDi>
    <basicUdiDi>4015672102424Q</basicUdiDi>
    <tradeName>Air Tube (NEB-TSC-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-TSC-L10E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:43:30.049Z</lastUpdated>
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    <udiDi>04015672102415</udiDi>
    <basicUdiDi>4015672102414N</basicUdiDi>
    <tradeName>Child Mask(SEBS)set (NEB-MSSS-E)</tradeName>
    <deviceName>Child Mask Set</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>Child Mask(SEBS)set (NEB-MSSS-E)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:43:29.254Z</lastUpdated>
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    <udiDi>04015672102408</udiDi>
    <basicUdiDi>4015672102404L</basicUdiDi>
    <tradeName>Adult Mask(SEBS) (NEB-MSLS-E)</tradeName>
    <deviceName>Adult Mask</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>Adult Mask(SEBS) (NEB-MSLS-E)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:43:28.489Z</lastUpdated>
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    <udiDi>04015672102392</udiDi>
    <basicUdiDi>40156721023953</basicUdiDi>
    <tradeName>Child Mask (NEB-MSMP-E)</tradeName>
    <deviceName>Child Mask</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-MSMP-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:43:24.456Z</lastUpdated>
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    <udiDi>04015672102385</udiDi>
    <basicUdiDi>4015672102384Z</basicUdiDi>
    <tradeName>Adult Mask (NEB-MSLP-E)</tradeName>
    <deviceName>Adult Mask</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-MSLP-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:43:23.656Z</lastUpdated>
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    <udiDi>04015672102378</udiDi>
    <basicUdiDi>4015672102374X</basicUdiDi>
    <tradeName>Nosepiece (NEB-NP-E)</tradeName>
    <deviceName>Nosepiece</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-NP-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:43:22.860Z</lastUpdated>
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    <udiDi>04015672102361</udiDi>
    <basicUdiDi>4015672102364V</basicUdiDi>
    <tradeName>Mouthpiece (NEB-MP-E)</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>NEB-MP-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:43:22.057Z</lastUpdated>
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    <udiDi>04015672102354</udiDi>
    <basicUdiDi>4015672102354T</basicUdiDi>
    <tradeName>Nebulizer Kit &amp; Mouthpiece Set (NEB-NSET3-28E)</tradeName>
    <deviceName>Nebulizer Kit &amp; Mouthpiece Set</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-NSET3-28E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:43:18.048Z</lastUpdated>
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    <udiDi>03700368601686</udiDi>
    <basicUdiDi>37003686ST202F8</basicUdiDi>
    <tradeName>SYST'AM 23S</tradeName>
    <deviceName>SYST'AM ST20</deviceName>
    <manufacturerName>SYSTEM ASSISTANCE MEDICAL</manufacturerName>
    <manufacturerSrn>FR-MF-000003517</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>23S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:22:43.367Z</lastUpdated>
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    <udiDi>03700368622469</udiDi>
    <basicUdiDi>3700368621401UX</basicUdiDi>
    <tradeName>SYST'AM LS2000+ 2140</tradeName>
    <deviceName>SYST'AM LS2000+</deviceName>
    <manufacturerName>SYSTEM ASSISTANCE MEDICAL</manufacturerName>
    <manufacturerSrn>FR-MF-000003517</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>2140</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:19:21.561Z</lastUpdated>
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    <udiDi>03700368611678</udiDi>
    <basicUdiDi>3700368641501VS</basicUdiDi>
    <tradeName>SYST'AM DP100+ 4150</tradeName>
    <deviceName>SYST'AM DP100+</deviceName>
    <manufacturerName>SYSTEM ASSISTANCE MEDICAL</manufacturerName>
    <manufacturerSrn>FR-MF-000003517</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>4150</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:18:16.697Z</lastUpdated>
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    <udiDi>06970979572027</udiDi>
    <basicUdiDi>697097957VP-MWYE</basicUdiDi>
    <tradeName>Nebualdo Easy Pro (Aldo-Union)</tradeName>
    <deviceName>Mesh Nebulizer(Wearable)</deviceName>
    <manufacturerName>Vapo Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014728</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VP-M10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:59:43.555Z</lastUpdated>
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    <udiDi>06970979571945</udiDi>
    <basicUdiDi>697097957VP-DCWB</basicUdiDi>
    <tradeName>DC Compressor Nebulizer (PRONTEX)</tradeName>
    <deviceName>DC Compressor Nebulizer</deviceName>
    <manufacturerName>Vapo Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014728</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VP-D1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:59:40.049Z</lastUpdated>
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