<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06923310902748</udiDi>
    <basicUdiDi>69233109PA17M7</basicUdiDi>
    <tradeName>Oxygen Mask with Reservoir Bag</tradeName>
    <deviceName>Oxygen Mask with Reservoir Bag</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>MDR 2017/745</legislation>
    <emdnCode>R03010206</emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA1700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:39.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310902533</udiDi>
    <basicUdiDi>69233109PA40619A</basicUdiDi>
    <tradeName>Manual Resuscitator</tradeName>
    <deviceName>Manual Resuscitator</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>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA40611111</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:35.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310901420</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName>Nebulizer kit</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>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0611</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:23.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900850</udiDi>
    <basicUdiDi>69233109PA16079D</basicUdiDi>
    <tradeName>Gas tube</tradeName>
    <deviceName>Gas tube</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>MDR 2017/745</legislation>
    <emdnCode>R03010204</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION TUBINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA160707</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:04.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900751</udiDi>
    <basicUdiDi>69233109PA31028Q</basicUdiDi>
    <tradeName>Anaesthetic Mask</tradeName>
    <deviceName>Anaesthetic Mask</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>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA310200</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:03.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900669</udiDi>
    <basicUdiDi>69233109PA16M5</basicUdiDi>
    <tradeName>Nasal Cannula</tradeName>
    <deviceName>Nasal Cannula</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>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA160512</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:17:57.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900638</udiDi>
    <basicUdiDi>69233109PA16018Z</basicUdiDi>
    <tradeName>Nasal Cannula</tradeName>
    <deviceName>Nasal Cannula</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>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA160101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:17:57.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900430</udiDi>
    <basicUdiDi>69233109PA160395</basicUdiDi>
    <tradeName>Nasal Cannula</tradeName>
    <deviceName>Nasal Cannula</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>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA160301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:17:55.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06922166510510</udiDi>
    <basicUdiDi>69221665YNM001QC</basicUdiDi>
    <tradeName>Nasal Mask</tradeName>
    <deviceName>Sleep apnea breathing therapy mask</deviceName>
    <manufacturerName>Suzhou Yuyue Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015854</manufacturerSrn>
    <authorisedRepresentativeName>Metrax GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005481</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MN02001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:15:23.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>06922166510244</udiDi>
    <basicUdiDi>69221665YPM001R2</basicUdiDi>
    <tradeName>Nasal Pillows Mask</tradeName>
    <deviceName>Sleep apnea breathing therapy mask</deviceName>
    <manufacturerName>Suzhou Yuyue Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015854</manufacturerSrn>
    <authorisedRepresentativeName>Metrax GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005481</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01004</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:15:21.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>06922166510572</udiDi>
    <basicUdiDi>69221665YFM001ML</basicUdiDi>
    <tradeName>Full Face Mask</tradeName>
    <deviceName>Sleep Apnea Breathing Therapy Mask</deviceName>
    <manufacturerName>Suzhou Yuyue Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015854</manufacturerSrn>
    <authorisedRepresentativeName>Metrax GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005481</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF01001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:12:36.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004251993</udiDi>
    <basicUdiDi>622300425OFM2007TS</basicUdiDi>
    <tradeName>ULTRAMED OXYGEN FACE MASK (With Nebulizer) (Paediatric Standard)</tradeName>
    <deviceName>ULTRAMED OXYGEN FACE MASK</deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2007-02</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:30:49.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004251603</udiDi>
    <basicUdiDi>622300425OFM2004TL</basicUdiDi>
    <tradeName>ULTRAMED OXYGEN FACE MASK (Medium Concentration With Tube) (Adult Standard)</tradeName>
    <deviceName>ULTRAMED OXYGEN FACE MASK</deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2004-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:30:47.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004251474</udiDi>
    <basicUdiDi>622300425NOC2003T8</basicUdiDi>
    <tradeName>ULTRAMED NASAL OXYGEN CANNULA (TWIN BORE NASAL OXYGEN CANNULA)- Adult</tradeName>
    <deviceName>ULTRAMED NASAL OXYGEN CANNULA (TWIN BORE NASAL OXYGEN CANNULA)</deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2003-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:30:46.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>05905996902060</udiDi>
    <basicUdiDi>59059969020pMDIRedT4</basicUdiDi>
    <tradeName>FindAir ONE for pMDI Red</tradeName>
    <deviceName>FINDAIR ONE for pMDI czujnik aktywacji inhalatora pMDI Red</deviceName>
    <manufacturerName>FindAir Sp. z o. o.</manufacturerName>
    <manufacturerSrn>PL-MF-000037094</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:11:36.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>05905996902022</udiDi>
    <basicUdiDi>59059969020TurbuhalerHD</basicUdiDi>
    <tradeName>FindAir ONE for Turbuhaler</tradeName>
    <deviceName>FINDAIR ONE for Turbuhaler czujnik aktywacji inhalatora Turbuhaler</deviceName>
    <manufacturerName>FindAir Sp. z o. o.</manufacturerName>
    <manufacturerSrn>PL-MF-000037094</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:11:29.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>05905996902015</udiDi>
    <basicUdiDi>59059969020Ellipta8M</basicUdiDi>
    <tradeName>FindAir ONE for Ellipta</tradeName>
    <deviceName>FINDAIR ONE for Ellipta czujnik aktywacji inhalatora Ellipta</deviceName>
    <manufacturerName>FindAir Sp. z o. o.</manufacturerName>
    <manufacturerSrn>PL-MF-000037094</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:11:29.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>05905996902008</udiDi>
    <basicUdiDi>59059969020pMDIBlueHB</basicUdiDi>
    <tradeName>FindAir ONE for pMDI Blue</tradeName>
    <deviceName>FINDAIR ONE for pMDI czujnik aktywacji inhalatora pMDI Blue</deviceName>
    <manufacturerName>FindAir Sp. z o. o.</manufacturerName>
    <manufacturerSrn>PL-MF-000037094</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:11:28.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904507279004</udiDi>
    <basicUdiDi>590450727RD32CN</basicUdiDi>
    <tradeName>Manual Resuscitator</tradeName>
    <deviceName>Manual Resuscitator</deviceName>
    <manufacturerName>AUG MEDICAL Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000019086</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AU-60152</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:47:35.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904507279677</udiDi>
    <basicUdiDi>590450727BV28C9</basicUdiDi>
    <tradeName>Air Cushion Mask</tradeName>
    <deviceName>590450727BV28C9</deviceName>
    <manufacturerName>AUG MEDICAL Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000019086</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AU-20116</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:43:33.050Z</lastUpdated>
  </row>
</eudamedExport>