<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>30889483648074</udiDi>
    <basicUdiDi>0889483NasalPap20035e4J</basicUdiDi>
    <tradeName>SuperNO2VA Nasal PAP Ventilation Device, Large</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SunMed</manufacturerName>
    <manufacturerSrn>US-MF-000009164</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNL-20-CE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:56:52.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>30889483605671</udiDi>
    <basicUdiDi>0889483EtSys20035eTY</basicUdiDi>
    <tradeName>SuperNO2VA Et Mask, Adult Large</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SunMed</manufacturerName>
    <manufacturerSrn>US-MF-000009164</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEL-20-CE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:56:49.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>30889483078833</udiDi>
    <basicUdiDi>0889483TF20013VHC_SpcS3</basicUdiDi>
    <tradeName>Ventlab BreatheRite™ Anti-Static Rigid VHC, with Premium ERGO Mask Infant</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ventlab</manufacturerName>
    <manufacturerSrn>US-MF-000008625</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR302-I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:56:43.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>00888277446635</udiDi>
    <basicUdiDi>0888277DC356NSL8</basicUdiDi>
    <tradeName>Comfort Flo Plus</tradeName>
    <deviceName>Hudson RCI Comfort Flo Plus Chin Strap</deviceName>
    <manufacturerName>Medline Industries, LP</manufacturerName>
    <manufacturerSrn>US-MF-000009717</manufacturerSrn>
    <authorisedRepresentativeName>Medline International France</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001814</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010280</emdnCode>
    <emdnDescription>OXYGEN THERAPY MASKS AND NASAL CANNULAS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>241210CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:42:05.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>00888277446628</udiDi>
    <basicUdiDi>0888277DC354NSKW</basicUdiDi>
    <tradeName>Comfort Flo Plus</tradeName>
    <deviceName>Hudson RCI Tracheostomy Adaptor</deviceName>
    <manufacturerName>Medline Industries, LP</manufacturerName>
    <manufacturerSrn>US-MF-000009717</manufacturerSrn>
    <authorisedRepresentativeName>Medline International France</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001814</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010205</emdnCode>
    <emdnDescription>TRACHEOSTOMY O2 SUPPLIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>241501CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:42:02.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>00888277446611</udiDi>
    <basicUdiDi>0888277DC354NSNCSH</basicUdiDi>
    <tradeName>Comfort Flo Plus</tradeName>
    <deviceName>Hudson RCI Confort Flo Plus Cannulas</deviceName>
    <manufacturerName>Medline Industries, LP</manufacturerName>
    <manufacturerSrn>US-MF-000009717</manufacturerSrn>
    <authorisedRepresentativeName>Medline International France</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001814</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>241212CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:42:01.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>00888277445751</udiDi>
    <basicUdiDi>0888277DC352NSOMSJ</basicUdiDi>
    <tradeName>Hudson RCI</tradeName>
    <deviceName>Husdon RCI Oxygen and Aerosol masks</deviceName>
    <manufacturerName>Medline Industries, LP</manufacturerName>
    <manufacturerSrn>US-MF-000009717</manufacturerSrn>
    <authorisedRepresentativeName>Medline International France</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001814</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010206</emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1061CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:41:56.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000012</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000012</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113311</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:49.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000029</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000029</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113312</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:49.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000036</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000036</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113313</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:49.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000098</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000098</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113319</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:49.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000166</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000166</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113326</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:49.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000173</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000173</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113327</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:49.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000180</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000180</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113328</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:49.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000609</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000609</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201438</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:49.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000616</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000616</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201439</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:49.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000623</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000623</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201443</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:49.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000630</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000630</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201453</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:49.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000647</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000647</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>669150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:48.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000654</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000654</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>669151</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:48.966Z</lastUpdated>
  </row>
</eudamedExport>