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<eudamedExport entity="devices">
  <row>
    <udiDi>00606959004566</udiDi>
    <basicUdiDi>B-00606959004566</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with 4 PT Headgr, Medium, Single Use</tradeName>
    <deviceName>AF531 Mask EE, LEAK 1, with 4 PT Headgr, Medium, Single Use</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:15.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959004559</udiDi>
    <basicUdiDi>B-00606959004559</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with 4 PT Headgear, Small, Single Use</tradeName>
    <deviceName>AF531 Mask EE, LEAK 1, with 4 PT Headgear, Small, Single Use</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:11.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959004160</udiDi>
    <basicUdiDi>B-00606959004160</basicUdiDi>
    <tradeName>L Performax Su W/Ee Leak 2 — Single</tradeName>
    <deviceName>L Performax Su W/Ee Leak 2 — Single</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1061620</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:10.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959000889</udiDi>
    <basicUdiDi>B-00606959000889</basicUdiDi>
    <tradeName>Performax Mask With Se, Single Patient Use, Intl, Large</tradeName>
    <deviceName>Performax Mask With Se, Single Patient Use, Intl, Large</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1054999</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:09.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959000858</udiDi>
    <basicUdiDi>B-00606959000858</basicUdiDi>
    <tradeName>Performax Mask, Single Patient Use, Ee, Intl, Small</tradeName>
    <deviceName>Performax Mask, Single Patient Use, Ee, Intl, Small</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1054966</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:09.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>05070004249816</udiDi>
    <basicUdiDi>50700042498CPRWRAPEUKU</basicUdiDi>
    <tradeName>Child CPRWrap™ (ages 1–8)</tradeName>
    <deviceName>CPRWrap™</deviceName>
    <manufacturerName>Rhuomai Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000052769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPR-EUE02</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:07:17.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959000873</udiDi>
    <basicUdiDi>B-30606959000873</basicUdiDi>
    <tradeName>S Performax Su Intl W/Se —10 Pack</tradeName>
    <deviceName>S Performax Su Intl W/Se —10 Pack</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1052547</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:53:07.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>05070004249830</udiDi>
    <basicUdiDi>50700042498CPRWRAPEUKU</basicUdiDi>
    <tradeName>Adult CPRWrap™ (ages 8+)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rhuomai Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000052769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPR-EUE01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:51:38.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>05070004249823</udiDi>
    <basicUdiDi>50700042498CPRWRAPEUKU</basicUdiDi>
    <tradeName>Infant CPRWrap™ (under 1 year)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rhuomai Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000052769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPR-EUE03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:51:11.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900768</udiDi>
    <basicUdiDi>69233109PA31028Q</basicUdiDi>
    <tradeName>Anaesthetic Mask</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA310201</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T12:17:44.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900775</udiDi>
    <basicUdiDi>69233109PA31028Q</basicUdiDi>
    <tradeName>Anaesthetic Mask</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA310202</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T12:17:44.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900782</udiDi>
    <basicUdiDi>69233109PA31028Q</basicUdiDi>
    <tradeName>Anaesthetic Mask</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA310203</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T12:17:44.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900799</udiDi>
    <basicUdiDi>69233109PA31028Q</basicUdiDi>
    <tradeName>Anaesthetic Mask</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA310204</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T12:17:44.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900805</udiDi>
    <basicUdiDi>69233109PA31028Q</basicUdiDi>
    <tradeName>Anaesthetic Mask</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA310205</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T12:17:44.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900812</udiDi>
    <basicUdiDi>69233109PA31028Q</basicUdiDi>
    <tradeName>Anaesthetic Mask</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA310206</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T12:17:44.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906033940097</udiDi>
    <basicUdiDi>890603394A140900RP</basicUdiDi>
    <tradeName>08906033940097</tradeName>
    <deviceName>Non-Invasive Ventilation  Device</deviceName>
    <manufacturerName>Phoenix Medical Systems Pvt. Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000022931</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010402</emdnCode>
    <emdnDescription>NIV HELMETS AND KITS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Cat.No: 7.2.3- 46</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:43:44.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975834955892</udiDi>
    <basicUdiDi>697583495CPAPSUA</basicUdiDi>
    <tradeName>CPAP Mask S</tradeName>
    <deviceName>CPAP mask</deviceName>
    <manufacturerName>Ningbo Hanyue Medical Technology CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000035941</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HY-008-3-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:51:27.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975834955885</udiDi>
    <basicUdiDi>697583495CPAPSUA</basicUdiDi>
    <tradeName>CPAP Mask M</tradeName>
    <deviceName>CPAP mask</deviceName>
    <manufacturerName>Ningbo Hanyue Medical Technology CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000035941</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HY-008-2-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:44:08.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975834955878</udiDi>
    <basicUdiDi>697583495CPAPSUA</basicUdiDi>
    <tradeName>CPAP Mask L</tradeName>
    <deviceName>CPAP mask</deviceName>
    <manufacturerName>Ningbo Hanyue Medical Technology CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000035941</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HY-008-1-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:35:33.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975834951139</udiDi>
    <basicUdiDi>697583495CPAPSUA</basicUdiDi>
    <tradeName>Nasal Pillow L</tradeName>
    <deviceName>CPAP mask</deviceName>
    <manufacturerName>Ningbo Hanyue Medical Technology CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000035941</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HY-008-1-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:28:32.079Z</lastUpdated>
  </row>
</eudamedExport>