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<eudamedExport entity="devices">
  <row>
    <udiDi>10620974004469</udiDi>
    <basicUdiDi>6209741423241341BM</basicUdiDi>
    <tradeName>OxyMulti-Mask™ Adult with Nebulizer</tradeName>
    <deviceName>OxyMulti-Mask™ with Nebulizer</deviceName>
    <manufacturerName>Southmedic Inc.</manufacturerName>
    <manufacturerSrn>CA-PR-000013764</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OMMK-4025-8</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:24:28.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119378</udiDi>
    <basicUdiDi>471081008NNED8B</basicUdiDi>
    <tradeName>RF 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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:31:08.579Z</lastUpdated>
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  <row>
    <udiDi>30889483078833</udiDi>
    <basicUdiDi>0889483TF20013VHC_SpcS3</basicUdiDi>
    <tradeName>Ventlab BreatheRite™ Anti-Static Rigid VHC, with Premium ERGO Mask Infant</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ventlab</manufacturerName>
    <manufacturerSrn>US-MF-000008625</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR302-I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:56:43.832Z</lastUpdated>
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  <row>
    <udiDi>10607411301145</udiDi>
    <basicUdiDi>0607411TF20013aAersMaskM5</basicUdiDi>
    <tradeName>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>1100-0-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:59:38.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974580754032</udiDi>
    <basicUdiDi>697458075A039GU</basicUdiDi>
    <tradeName>Spacer for aerosol</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Yingmed Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002183</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010302</emdnCode>
    <emdnDescription>AEROSOL PORTABLE INHALERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>003702</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:16.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974580754049</udiDi>
    <basicUdiDi>697458075A039GU</basicUdiDi>
    <tradeName>Spacer for aerosol</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Yingmed Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002183</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010302</emdnCode>
    <emdnDescription>AEROSOL PORTABLE INHALERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>003703</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:02.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OM-8163158</udiDi>
    <basicUdiDi>B-OM-8163158</basicUdiDi>
    <tradeName>D-OM-8163158</tradeName>
    <deviceName>Soft Tracheostomy Mask, Child</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-81631</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:14:46.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OM-8161152</udiDi>
    <basicUdiDi>B-OM-8161152</basicUdiDi>
    <tradeName>D-OM-8161152</tradeName>
    <deviceName>Soft Tracheostomy Mask, Adult</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-81611</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:14:46.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-32862VU</udiDi>
    <basicUdiDi>B-NB-32862VU</basicUdiDi>
    <tradeName>D-NB-32862VU</tradeName>
    <deviceName>Low Flow Nebulizer Bottle W/ Mouth Piece</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-32862</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:22:10.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-32860VQ</udiDi>
    <basicUdiDi>B-NB-32860VQ</basicUdiDi>
    <tradeName>D-NB-32860VQ</tradeName>
    <deviceName>Low Flow Nebulizer Bottle W/O Mouth Piece</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-32860</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:22:09.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-32762VP</udiDi>
    <basicUdiDi>B-NB-32762VP</basicUdiDi>
    <tradeName>D-NB-32762VP</tradeName>
    <deviceName>Nebulizer Kit W/ Elbow, Aerosol Mask, Mouth Piece, 7 FT Oxygen Tube, Child</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-32762</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:22:08.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-32761VM</udiDi>
    <basicUdiDi>B-NB-32761VM</basicUdiDi>
    <tradeName>D-NB-32761VM</tradeName>
    <deviceName>Nebulizer Kit W/ Elbow, Aerosol Mask, 7 FT Oxygen Tube, Child</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-32761</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:20:32.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-32759W2</udiDi>
    <basicUdiDi>B-NB-32759W2</basicUdiDi>
    <tradeName>D-NB-32759W2</tradeName>
    <deviceName>Nebulizer Kit, PVC Mask, Mouth Piece, 7 FT Oxygen Tube, Child</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-32759</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:20:31.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-32758VY</udiDi>
    <basicUdiDi>B-NB-32758VY</basicUdiDi>
    <tradeName>D-NB-32758VY</tradeName>
    <deviceName>Nebulizer Kit, PVC Mask, 7 FT Oxygen Tube, Child</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-32758</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:20:30.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-32757VW</udiDi>
    <basicUdiDi>B-NB-32757VW</basicUdiDi>
    <tradeName>D-NB-32757VW</tradeName>
    <deviceName>Nebulizer Kit, PVC Mask, Mouth Piece, 7 FT Oxygen Tube, Adult</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-32757</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:20:27.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-32756VU</udiDi>
    <basicUdiDi>B-NB-32756VU</basicUdiDi>
    <tradeName>D-NB-32756VU</tradeName>
    <deviceName>Nebulizer Kit, PVC Mask, 7 FT Oxygen Tube, Adult</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-32756</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:20:26.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-32755VS</udiDi>
    <basicUdiDi>B-NB-32755VS</basicUdiDi>
    <tradeName>D-NB-32755VS</tradeName>
    <deviceName>Nebulizer Kit, Aerofit Mask, Mouth Piece, 7 FT Oxygen Tube, Child</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-32755</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:20:25.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-32754VQ</udiDi>
    <basicUdiDi>B-NB-32754VQ</basicUdiDi>
    <tradeName>D-NB-32754VQ</tradeName>
    <deviceName>Nebulizer Kit, Aerofit Mask, 7 FT Oxygen Tube, Child</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-32754</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:20:24.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-32753VN</udiDi>
    <basicUdiDi>B-NB-32753VN</basicUdiDi>
    <tradeName>D-NB-32753VN</tradeName>
    <deviceName>Nebulizer Kit, Aerofit Mask, Mouth Piece, 7 FT Oxygen Tube, Adult</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-32753</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:20:21.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-32752VL</udiDi>
    <basicUdiDi>B-NB-32752VL</basicUdiDi>
    <tradeName>D-NB-32752VL</tradeName>
    <deviceName>Nebulizer Kit, Aerofit Mask, 7 FT Oxygen Tube, Adult</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-32752</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:20:19.796Z</lastUpdated>
  </row>
</eudamedExport>