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<eudamedExport entity="devices">
  <row>
    <udiDi>06936881155901</udiDi>
    <basicUdiDi>69449327FA07A01DA</basicUdiDi>
    <tradeName>Welllead Dcisposable Air Cushion Face Mask</tradeName>
    <deviceName>Disposable Air Cushion Face Mask</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</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>FA07A050710</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:40.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816660443</udiDi>
    <basicUdiDi>69449327FR01A04K3</basicUdiDi>
    <tradeName>Welllead Non-Rebreath Mask</tradeName>
    <deviceName>Non-Rebreath Mask</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A04013F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:10.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053041133</udiDi>
    <basicUdiDi>69449040AB020000333W</basicUdiDi>
    <tradeName>Nasal cannula</tradeName>
    <deviceName>Nasal cannula</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020302</emdnCode>
    <emdnDescription>HIGH FLOW THERAPY NASAL CANNULAS (HFNC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HF132S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:49:24.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053037969</udiDi>
    <basicUdiDi>69449040AB020000013H</basicUdiDi>
    <tradeName>Headgear</tradeName>
    <deviceName>Headgear/Bonnet</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RA15103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:49:00.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053037792</udiDi>
    <basicUdiDi>69449040AB0200002947</basicUdiDi>
    <tradeName>Bonnet</tradeName>
    <deviceName>Headgear/Bonnet</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RA15201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:49:00.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053006477</udiDi>
    <basicUdiDi>69449040AB020000023K</basicUdiDi>
    <tradeName>Nasal mask</tradeName>
    <deviceName>Nasal Mask/Nasal Prong</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010280</emdnCode>
    <emdnDescription>OXYGEN THERAPY MASKS AND NASAL CANNULAS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504-NM(XL)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:05.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942272610003</udiDi>
    <basicUdiDi>69422726P5.01.01XW</basicUdiDi>
    <tradeName>06942272610003</tradeName>
    <deviceName>CPR Face Shield</deviceName>
    <manufacturerName>FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)</manufacturerName>
    <manufacturerSrn>CN-MF-000009645</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS‐100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:37:04.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942272600011</udiDi>
    <basicUdiDi>69422726P5.01.07YA</basicUdiDi>
    <tradeName>06942272600011</tradeName>
    <deviceName>Mouth to Mouth Resuscitation Mask</deviceName>
    <manufacturerName>FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)</manufacturerName>
    <manufacturerSrn>CN-MF-000009645</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:36:52.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941617113926</udiDi>
    <basicUdiDi>693811937357K7</basicUdiDi>
    <tradeName>06941617113926</tradeName>
    <deviceName>Anesthesia mask</deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013924</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EM100310</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:11:55.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941617113834</udiDi>
    <basicUdiDi>693811937356K5</basicUdiDi>
    <tradeName>06941617113834</tradeName>
    <deviceName>Anesthesia mask</deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013924</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMB000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:11:55.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941617109370</udiDi>
    <basicUdiDi>693811937358K9</basicUdiDi>
    <tradeName>06941617109370</tradeName>
    <deviceName>Anesthesia mask</deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013924</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMS000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:11:49.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938119387771</udiDi>
    <basicUdiDi>693811937367KA</basicUdiDi>
    <tradeName>06938119387771</tradeName>
    <deviceName>Manual Resuscitator</deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013924</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRPAO00</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:08:17.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934325308111</udiDi>
    <basicUdiDi>69343253R03010332E78</basicUdiDi>
    <tradeName>06934325308111</tradeName>
    <deviceName>Nebulizati on Mask</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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:57:13.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934325307015</udiDi>
    <basicUdiDi>69343253R030132BYJ</basicUdiDi>
    <tradeName>06934325307015</tradeName>
    <deviceName>Nebulizer Mask</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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XL7</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:57:11.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931515008578</udiDi>
    <basicUdiDi>69315150MW107JD</basicUdiDi>
    <tradeName>06931515008578</tradeName>
    <deviceName>Nebulizer mask</deviceName>
    <manufacturerName>HOSPITAL&amp;HOMECARE IMP. &amp; EXP. CO.,LTD NANJING</manufacturerName>
    <manufacturerSrn>CN-MF-000038483</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>MW10701001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:49:52.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931515061078</udiDi>
    <basicUdiDi>69315150MW105J9</basicUdiDi>
    <tradeName>06931515061078</tradeName>
    <deviceName>Oxygen Mask</deviceName>
    <manufacturerName>HOSPITAL&amp;HOMECARE IMP. &amp; EXP. CO.,LTD NANJING</manufacturerName>
    <manufacturerSrn>CN-MF-000038483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW10501001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:49:51.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924993400118</udiDi>
    <basicUdiDi>692499340735365G</basicUdiDi>
    <tradeName>06924993400118</tradeName>
    <deviceName>Medical Face Mask</deviceName>
    <manufacturerName>Honz Pharmaceutical Co,.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024508</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030299</emdnCode>
    <emdnDescription>RESPIRATORY BALLOONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:25:09.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980112744</udiDi>
    <basicUdiDi>69239801NR2KASE</basicUdiDi>
    <tradeName>NIV mask, small, including headgear</tradeName>
    <deviceName>Reusable Mask</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XMR0074</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:32.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980111655</udiDi>
    <basicUdiDi>69239801FD2AEKW</basicUdiDi>
    <tradeName>Neb-1 Nebulizer Kit</tradeName>
    <deviceName>Disposable Aerosol therapy</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</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>AD0037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:30.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980108334</udiDi>
    <basicUdiDi>69239801ND2MBPL</basicUdiDi>
    <tradeName>NHF Prong Kit, #4</tradeName>
    <deviceName>Disposable Oxygen therapy</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020302</emdnCode>
    <emdnDescription>HIGH FLOW THERAPY NASAL CANNULAS (HFNC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:13.452Z</lastUpdated>
  </row>
</eudamedExport>