<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>04711064682939</udiDi>
    <basicUdiDi>47126880500007258RPASY</basicUdiDi>
    <tradeName>04711064682939</tradeName>
    <deviceName>Respiratory accessories</deviceName>
    <manufacturerName>Hsiner Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007258</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</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>00003456</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:27:29.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810101649</udiDi>
    <basicUdiDi>471081008NNAM8H</basicUdiDi>
    <tradeName>Headgear for Nasal Mask, White</tradeName>
    <deviceName>Disposable Headgear</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>MDR 2017/745</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0079</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:42.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810081439</udiDi>
    <basicUdiDi>471081008RNAM9D</basicUdiDi>
    <tradeName>Headgear for CPAP Mask, S, Silicone</tradeName>
    <deviceName>Reusable Headgear</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>MDR 2017/745</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:05.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711064683783</udiDi>
    <basicUdiDi>47126880500007258RPASY</basicUdiDi>
    <tradeName>04711064683783</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hsiner Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007258</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C10200-023</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-25T07:37:54.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959002142</udiDi>
    <basicUdiDi>0606959BM202LJ</basicUdiDi>
    <tradeName>Premium Chin Strap</tradeName>
    <deviceName>Mask Accessory</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</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>1012911</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:52:23.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>07045432084153</udiDi>
    <basicUdiDi>B-07045432084153</basicUdiDi>
    <tradeName>Laerdal Disposable Mask</tradeName>
    <deviceName>The BAG II Disposable Resuscitator</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>845170</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:56:50.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>07045432084146</udiDi>
    <basicUdiDi>B-07045432084146</basicUdiDi>
    <tradeName>Laerdal Disposable Mask</tradeName>
    <deviceName>The BAG II  Disposable Resuscitator</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>845160</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:56:49.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>07045432084139</udiDi>
    <basicUdiDi>B-07045432084139</basicUdiDi>
    <tradeName>Laerdal Disposable Mask</tradeName>
    <deviceName>The BAG II Disposable Resuscitator</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>845270</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:56:48.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>07045432084122</udiDi>
    <basicUdiDi>B-07045432084122</basicUdiDi>
    <tradeName>Laerdal Disposable Mask</tradeName>
    <deviceName>The BAG II Disposable Resuscitator</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>845260</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:56:44.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>07045432084115</udiDi>
    <basicUdiDi>B-07045432084115</basicUdiDi>
    <tradeName>Laerdal Disposable Mask</tradeName>
    <deviceName>The BAG II Disposable Resuscitator</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>845256</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:56:43.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>07045432083958</udiDi>
    <basicUdiDi>B-07045432083958</basicUdiDi>
    <tradeName>Laerdal Disposable Mask with Inflation Port</tradeName>
    <deviceName>The BAG II Disposable Resuscitator</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>845250</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:56:42.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>07045432083941</udiDi>
    <basicUdiDi>B-07045432083941</basicUdiDi>
    <tradeName>Laerdal Disposable Mask</tradeName>
    <deviceName>The BAG II Disposable Resuscitator</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>845150</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:56:37.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>07045432083927</udiDi>
    <basicUdiDi>B-07045432083927</basicUdiDi>
    <tradeName>Laerdal Disposable Mask</tradeName>
    <deviceName>The BAG II Disposable Resuscitator</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>845156</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:56:36.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>07045432083552</udiDi>
    <basicUdiDi>B-07045432083552</basicUdiDi>
    <tradeName>Laerdal Disposable Mask</tradeName>
    <deviceName>The BAG II Disposable Resuscitator</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>845255</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:56:35.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>07045432083545</udiDi>
    <basicUdiDi>B-07045432083545</basicUdiDi>
    <tradeName>Laerdal Disposable Mask</tradeName>
    <deviceName>The BAG II Disposable Resuscitator</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>845155</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:56:34.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056209010144</udiDi>
    <basicUdiDi>805620901mbxSC</basicUdiDi>
    <tradeName>MorbideX® – Protective cushion Adult</tradeName>
    <deviceName>MorbideX® - Protective Cushion</deviceName>
    <manufacturerName>BenCorpp Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000023046</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>MBX-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:06:04.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082245</udiDi>
    <basicUdiDi>471081008RNAM9D</basicUdiDi>
    <tradeName>Headgear for CPAP Mask, L, Silicone</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>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084942</udiDi>
    <basicUdiDi>471081008RNAM9D</basicUdiDi>
    <tradeName>Headgear for Nasal Mask, L</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>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0042</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810086199</udiDi>
    <basicUdiDi>471081008RNAM9D</basicUdiDi>
    <tradeName>Headgear for Mask, S, Silicone</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>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0037</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.034Z</lastUpdated>
  </row>
</eudamedExport>