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<eudamedExport entity="devices">
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    <udiDi>07898935580208</udiDi>
    <basicUdiDi>B-07898935580208</basicUdiDi>
    <tradeName>Maxi Haler NV 45 x 1.00 x 2.0</tradeName>
    <deviceName>Maxi Haler NV 45 x 1.00 x 2.0</deviceName>
    <manufacturerName>EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA.</manufacturerName>
    <manufacturerSrn>BR-MF-000020354</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010302</emdnCode>
    <emdnDescription>AEROSOL PORTABLE INHALERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03-056-11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:48.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898935580192</udiDi>
    <basicUdiDi>B-07898935580192</basicUdiDi>
    <tradeName>Vertical Haler 3.4mm - R</tradeName>
    <deviceName>Vertical Haler 3.4mm - R</deviceName>
    <manufacturerName>EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA.</manufacturerName>
    <manufacturerSrn>BR-MF-000020354</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010302</emdnCode>
    <emdnDescription>AEROSOL PORTABLE INHALERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03-084-14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:48.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898935580185</udiDi>
    <basicUdiDi>B-07898935580185</basicUdiDi>
    <tradeName>Vertical Haler 3.4mm  NV - R</tradeName>
    <deviceName>Vertical Haler 3.4mm  NV - R</deviceName>
    <manufacturerName>EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA.</manufacturerName>
    <manufacturerSrn>BR-MF-000020354</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010302</emdnCode>
    <emdnDescription>AEROSOL PORTABLE INHALERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03-084-23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:47.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974269382365</udiDi>
    <basicUdiDi>B-06974269382365</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>nebulizer mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0908</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:25.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974269382310</udiDi>
    <basicUdiDi>B-06974269382310</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>nebulizer mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0907</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:16.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974269382303</udiDi>
    <basicUdiDi>B-06974269382303</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>nebulizer mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0906</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:14.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974269382297</udiDi>
    <basicUdiDi>B-06974269382297</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>nebulizer mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0905</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:14.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974269382280</udiDi>
    <basicUdiDi>B-06974269382280</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>Nebulizer mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0904</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:12.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974269382198</udiDi>
    <basicUdiDi>B-06974269382198</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>nebulizer mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0903</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:41:46.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974269382181</udiDi>
    <basicUdiDi>B-06974269382181</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>nebulizer mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0902</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:41:44.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974269382174</udiDi>
    <basicUdiDi>B-06974269382174</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>nebulizer mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:41:42.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974269381696</udiDi>
    <basicUdiDi>B-06974269381696</basicUdiDi>
    <tradeName>DCT</tradeName>
    <deviceName>Nebulizer mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H7 1495</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:41:08.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973351317322</udiDi>
    <basicUdiDi>B-06973351317322</basicUdiDi>
    <tradeName>Nebulizer Mask</tradeName>
    <deviceName>Nebulizer Mask</deviceName>
    <manufacturerName>Ningbo Trustlab Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008493</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT012-100</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:08:17.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973351317315</udiDi>
    <basicUdiDi>B-06973351317315</basicUdiDi>
    <tradeName>Nebulizer Mask</tradeName>
    <deviceName>Nebulizer Mask</deviceName>
    <manufacturerName>Ningbo Trustlab Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008493</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT012-100</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:08:16.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934325307022</udiDi>
    <basicUdiDi>69343253R030132BYJ</basicUdiDi>
    <tradeName>06934325307022</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FEELLIFE HEALTH INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000000782</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L7</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:47:56.950Z</lastUpdated>
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  <row>
    <udiDi>08907265011142</udiDi>
    <basicUdiDi>8907265B019YV</basicUdiDi>
    <tradeName>AERO MIST</tradeName>
    <deviceName>NEBULIZER: Mask / Mouth Piece with Nebulization Chamber and Tubing.</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-2074S KAD</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:35.566Z</lastUpdated>
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    <udiDi>08904399170752</udiDi>
    <basicUdiDi>89043991HSRTD026N</basicUdiDi>
    <tradeName>Nebulizer Mask</tradeName>
    <deviceName>Nebulizer Mask</deviceName>
    <manufacturerName>Harsoria Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000018349</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7075</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:33:20.288Z</lastUpdated>
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  <row>
    <udiDi>08902120207418</udiDi>
    <basicUdiDi>8902120B019S2</basicUdiDi>
    <tradeName>AERO-MIST</tradeName>
    <deviceName>NEBULISER: Mask / Mouth Piece with Nebulization Chamber and Tubing</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-2074</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:10.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095201114</udiDi>
    <basicUdiDi>890209520111DK</basicUdiDi>
    <tradeName>Nebulizer Mask</tradeName>
    <deviceName>Nebulizer Mask</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20111</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:19:46.751Z</lastUpdated>
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  <row>
    <udiDi>08699931750027</udiDi>
    <basicUdiDi>869993175NBL001U6</basicUdiDi>
    <tradeName>Nebulizer Set - Adult</tradeName>
    <deviceName>Nebulizer Set - Adult</deviceName>
    <manufacturerName>GENJECT SAGLIK URUNLERI VE KIMYA SAN. VE TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000024441</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>NBL001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:15:05.994Z</lastUpdated>
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