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<eudamedExport entity="devices">
  <row>
    <udiDi>D-8901117WAK0123MUSF</udiDi>
    <basicUdiDi>B-8901117WAK0123MUSF</basicUdiDi>
    <tradeName>Wakeeta</tradeName>
    <deviceName>Tiotropium Bromide Inhalation Device</deviceName>
    <manufacturerName>Cipla Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000038939</manufacturerSrn>
    <authorisedRepresentativeName>Cipla Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000038918</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Not Applicable for Wakeeta device</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:30:23.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436037137631</udiDi>
    <basicUdiDi>843603713GT.0252Q</basicUdiDi>
    <tradeName>Creo Medical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Creo Medical, S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000000385</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN10018002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:49:08.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436037137648</udiDi>
    <basicUdiDi>843603713GT.0252Q</basicUdiDi>
    <tradeName>Creo Medical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Creo Medical, S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000000385</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN10018003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:49:08.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436037137655</udiDi>
    <basicUdiDi>843603713GT.0252Q</basicUdiDi>
    <tradeName>Creo Medical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Creo Medical, S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000000385</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN10018004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:49:08.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436037137662</udiDi>
    <basicUdiDi>843603713GT.0252Q</basicUdiDi>
    <tradeName>Creo Medical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Creo Medical, S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000000385</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN10018011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:49:08.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436037137679</udiDi>
    <basicUdiDi>843603713GT.0252Q</basicUdiDi>
    <tradeName>Creo Medical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Creo Medical, S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000000385</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN2360000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:49:08.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>03666256010995</udiDi>
    <basicUdiDi>3666256DI100AP0VENU0802SX</basicUdiDi>
    <tradeName>Embout buccal 22M/15F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Int'Air Médical</manufacturerName>
    <manufacturerSrn>FR-MF-000000328</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC26.EA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T20:51:07.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>03666256011008</udiDi>
    <basicUdiDi>3666256DI100AP0VENU0802SX</basicUdiDi>
    <tradeName>Embout buccal 22M/15F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Int'Air Médical</manufacturerName>
    <manufacturerSrn>FR-MF-000000328</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC26.WW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T20:51:07.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860008017956</udiDi>
    <basicUdiDi>8600080179FenomDW</basicUdiDi>
    <tradeName>Fenom Pro</tradeName>
    <deviceName>Fenom Pro Mouthpiece</deviceName>
    <manufacturerName>CAIRE Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030745</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-0019-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:01:38.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056351381086</udiDi>
    <basicUdiDi>80563513810862L</basicUdiDi>
    <tradeName>APRIBOCCA</tradeName>
    <deviceName>APRIBOCCA</deviceName>
    <manufacturerName>TAUMEDIPLAST s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000031607</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APRIBOCCA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:15:23.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810087639</udiDi>
    <basicUdiDi>471081008NNbLB3</basicUdiDi>
    <tradeName>Mouth Piece, 22/19mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AL0001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:19.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810107764</udiDi>
    <basicUdiDi>471081008NNbLB3</basicUdiDi>
    <tradeName>Mouth Piece, 22F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AL0002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:54.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810112133</udiDi>
    <basicUdiDi>471081008NNbLB3</basicUdiDi>
    <tradeName>Mouth Piece, 13M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0028</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:54.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810115776</udiDi>
    <basicUdiDi>471081008NNbLB3</basicUdiDi>
    <tradeName>Mouth Piece, L18F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0030</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:52.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810117343</udiDi>
    <basicUdiDi>471081008NNbLB3</basicUdiDi>
    <tradeName>Elbow Mouth Piece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XTB0001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:51.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974909514002</udiDi>
    <basicUdiDi>697490951CA22D01E5</basicUdiDi>
    <tradeName>Mouthpiece</tradeName>
    <deviceName>Mouthpiece</deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:43:19.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974909513982</udiDi>
    <basicUdiDi>697490951CA22C01DY</basicUdiDi>
    <tradeName>Mouthpiece</tradeName>
    <deviceName>Mouthpiece</deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:43:17.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934325305493</udiDi>
    <basicUdiDi>69343253R900134A4B</basicUdiDi>
    <tradeName>06934325305493</tradeName>
    <deviceName>Mouthpiece</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>MDR 2017/745</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:58:02.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970701961938</udiDi>
    <basicUdiDi>697070196420131001LF</basicUdiDi>
    <tradeName>lifesense</tradeName>
    <deviceName>Medical Mouthpieces</deviceName>
    <manufacturerName>Taian Dalu Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003009</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD1012</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:18:25.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934325311838</udiDi>
    <basicUdiDi>69343253R900134A4B</basicUdiDi>
    <tradeName>ApWell Mouthpiece</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>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:47:45.470Z</lastUpdated>
  </row>
</eudamedExport>