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    <tradeName>Neb.Easy Nebulizer, 18M</tradeName>
    <deviceName>Nebulizer</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
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    <reference>AD0002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:10.212Z</lastUpdated>
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    <udiDi>04710810082788</udiDi>
    <basicUdiDi>471081008NNE37B</basicUdiDi>
    <tradeName>AM-2 Aerosol Mask, Child</tradeName>
    <deviceName>Aerosol Mask &amp; Connector</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0068</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:06.271Z</lastUpdated>
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    <udiDi>04710810082085</udiDi>
    <basicUdiDi>471081008NNE47D</basicUdiDi>
    <tradeName>LVN Nebulizer, PP</tradeName>
    <deviceName>LVN Nebulizer Kit</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
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    <reference>AH0032</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:29.192Z</lastUpdated>
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    <udiDi>04710810081835</udiDi>
    <basicUdiDi>471081008NNE57F</basicUdiDi>
    <tradeName>Isolated Nebulizer Kit</tradeName>
    <deviceName>Isolated Nebulizer Kit</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0035</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:16.383Z</lastUpdated>
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    <udiDi>04710810081828</udiDi>
    <basicUdiDi>471081008NNED8B</basicUdiDi>
    <tradeName>Neb-1 Nebulizer Kit</tradeName>
    <deviceName>Nebulizer Kit</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010303</emdnCode>
    <emdnDescription>AEROSOL THERAPY TUBINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0037</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:12.390Z</lastUpdated>
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    <udiDi>04710810080586</udiDi>
    <basicUdiDi>471081008NNE177</basicUdiDi>
    <tradeName>Neb.Easy AM-1 Mask, Adult w/Tube</tradeName>
    <deviceName>Nebulizer Kit, w/mask</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0049</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:23:25.828Z</lastUpdated>
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    <udiDi>04065477000010</udiDi>
    <basicUdiDi>4065477HANDIHALERRH</basicUdiDi>
    <tradeName>HandiHaler</tradeName>
    <deviceName>HandiHaler</deviceName>
    <manufacturerName>Boehringer Ingelheim Pharma GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000015595</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010302</emdnCode>
    <emdnDescription>AEROSOL PORTABLE INHALERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HH OEFFHI KAMMER AUS PC EU/ROW / 87712</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:21:48.528Z</lastUpdated>
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    <udiDi>04065477001017</udiDi>
    <basicUdiDi>4065477RESPIMATEJ</basicUdiDi>
    <tradeName>Respimat</tradeName>
    <deviceName>Respimat</deviceName>
    <manufacturerName>Boehringer Ingelheim Pharma GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000015595</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010302</emdnCode>
    <emdnDescription>AEROSOL PORTABLE INHALERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INH RES A5.2 BERO 120HUB GUMD / 84976</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:21:46.222Z</lastUpdated>
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    <udiDi>20607411102039</udiDi>
    <basicUdiDi>0607411TF20013aAersMaskM5</basicUdiDi>
    <tradeName>I-Guard Aerosol Mask (Adult), elastic strap fixation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Salter Labs</manufacturerName>
    <manufacturerSrn>US-MF-000007934</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8107V-0-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:55:39.749Z</lastUpdated>
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    <udiDi>08437028850010</udiDi>
    <basicUdiDi>8437028850MAS1000000110T8</basicUdiDi>
    <tradeName>08437028850010</tradeName>
    <deviceName>MASCARILLA SILICONA</deviceName>
    <manufacturerName>Reiner Medtech S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000048477</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00600INT000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T01:58:46.348Z</lastUpdated>
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    <udiDi>04975479498893</udiDi>
    <basicUdiDi>497547949889RA</basicUdiDi>
    <tradeName>04975479498893</tradeName>
    <deviceName>NEB-DMC1-20AP</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>R03010399</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NEB-DMC1-20AP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:13:31.091Z</lastUpdated>
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    <tradeName>04975479498626</tradeName>
    <deviceName>NEB-NSETB-8A</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NEB-NSETB-8AAP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:12:43.067Z</lastUpdated>
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    <basicUdiDi>497547949792QS</basicUdiDi>
    <tradeName>04975479497926</tradeName>
    <deviceName>NEB-NSET3-28E (NEB-NSET3-28AP)</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NEB-NSET3-28AP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:12:12.521Z</lastUpdated>
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    <tradeName>04975479497919</tradeName>
    <deviceName>NEB-HS-L15E(NEB-HS-L15AP)</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>R03010303</emdnCode>
    <emdnDescription>AEROSOL THERAPY TUBINGS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NEB-HS-L15AP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:12:11.720Z</lastUpdated>
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    <tradeName>04975479497902</tradeName>
    <deviceName>NEB-MSILS-78E (NEB-MSILS-78AP)</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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NEB-MSILS-78AP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:12:10.114Z</lastUpdated>
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    <deviceName>NEB-LMCC-78E (NEB-LMCC-78AP)</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
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    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NEB-LMCC-78AP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:12:07.711Z</lastUpdated>
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    <tradeName>04975479497889</tradeName>
    <deviceName>U12-1-E (NE-U12-1AP)</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>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NE-U12-1AP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:12:06.118Z</lastUpdated>
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    <deviceName>NEB-NZU-78E (NEB-NZU-78AP)</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>
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    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NEB-NZU-78AP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:12:05.318Z</lastUpdated>
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    <tradeName>04975479497865</tradeName>
    <deviceName>NEB-BTL-10E (NEB-BTL-10AP)</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>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NEB-BTL-10AP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:12:03.714Z</lastUpdated>
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    <tradeName>04975479497858</tradeName>
    <deviceName>NEB-MC-10E (NEB-MC-10AP)</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>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NEB-MC-10AP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T14:12:00.528Z</lastUpdated>
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