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<eudamedExport entity="devices">
  <row>
    <udiDi>08902120240330</udiDi>
    <basicUdiDi>8902120B019S2</basicUdiDi>
    <tradeName>AERO COMFORT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2403</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120240347</udiDi>
    <basicUdiDi>8902120B019S2</basicUdiDi>
    <tradeName>AERO COMFORT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2403S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120240354</udiDi>
    <basicUdiDi>8902120B019S2</basicUdiDi>
    <tradeName>AERO COMFORT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2403S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120240361</udiDi>
    <basicUdiDi>8902120B019S2</basicUdiDi>
    <tradeName>AERO COMFORT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2403S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>30889483093393</udiDi>
    <basicUdiDi>0889483TF20013VHC_SpcS3</basicUdiDi>
    <tradeName>Ventlab BreatheRite™ Anti-Static Rigid VHC, with Economy Spacer Mask Pediatric</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>BR320</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:40:36.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>30889483092396</udiDi>
    <basicUdiDi>0889483TF20013VHC_SpcS3</basicUdiDi>
    <tradeName>Ventlab BreatheRite™ Anti-Static Rigid VHC, with Premium ERGO Mask Small Child</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>BR303-I</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:40:25.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>30889483160972</udiDi>
    <basicUdiDi>0889483TF20013VHC_SpcS3</basicUdiDi>
    <tradeName>Ventlab BreatheRite™ Anti-Static Rigid VHC, with Premium ERGO Mask Adult</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>BR305-I</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:40:22.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310912068</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:02:29.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310912051</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0615</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:02:28.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310912044</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0605</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:02:27.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310912037</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0614</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:02:25.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310912020</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0608</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:02:23.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310912013</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0609</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:02:21.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310912006</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0606</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:02:20.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310911993</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0607</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:02:19.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310911986</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0620</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:02:16.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310911979</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0619</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:02:14.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310911962</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0618</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:02:13.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310911955</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0617</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:02:11.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310911948</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0616</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:02:09.542Z</lastUpdated>
  </row>
</eudamedExport>