<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09120087610068</udiDi>
    <basicUdiDi>912008761HUM100088</basicUdiDi>
    <tradeName>LiMAx Breathing Mask Set A</tradeName>
    <deviceName>LiMAx Breathing Mask</deviceName>
    <manufacturerName>Humedics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005094</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201002M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:39:16.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906118133567</udiDi>
    <basicUdiDi>890611813YM-ML10167U</basicUdiDi>
    <tradeName>CPAP/BPAP Unit Ambient Air Filter, Reusable</tradeName>
    <deviceName>CPAP/BPAP Unit Ambient Air Filter, Reusable</deviceName>
    <manufacturerName>TECHO INFO LTD</manufacturerName>
    <manufacturerSrn>UK-MF-000048031</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM-ML1016</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:24:44.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906118133550</udiDi>
    <basicUdiDi>890611813YM-ML10157S</basicUdiDi>
    <tradeName>CPAP/BPAP Nasal Mask, Reusable</tradeName>
    <deviceName>CPAP/BPAP Nasal Mask, Reusable</deviceName>
    <manufacturerName>TECHO INFO LTD</manufacturerName>
    <manufacturerSrn>UK-MF-000048031</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM-ML1015</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:24:43.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906118133543</udiDi>
    <basicUdiDi>890611813YM-ML10147Q</basicUdiDi>
    <tradeName>Breathing Circuit Tube Holder</tradeName>
    <deviceName>Breathing Circuit Tube Holder</deviceName>
    <manufacturerName>TECHO INFO LTD</manufacturerName>
    <manufacturerSrn>UK-MF-000048031</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM-ML1014</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:24:39.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906118133536</udiDi>
    <basicUdiDi>890611813YM-ML10017F</basicUdiDi>
    <tradeName>CPAP Replacement Headgear</tradeName>
    <deviceName>CPAP Replacement Headgear</deviceName>
    <manufacturerName>TECHO INFO LTD</manufacturerName>
    <manufacturerSrn>UK-MF-000048031</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM-ML1001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:24:38.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906118133529</udiDi>
    <basicUdiDi>890611813YM-ML10087V</basicUdiDi>
    <tradeName>Hose Pipe</tradeName>
    <deviceName>Hose Pipe</deviceName>
    <manufacturerName>TECHO INFO LTD</manufacturerName>
    <manufacturerSrn>UK-MF-000048031</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM-ML1008</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:24:37.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906118133512</udiDi>
    <basicUdiDi>890611813YM-ML10097X</basicUdiDi>
    <tradeName>CPAP Replacement Elbow</tradeName>
    <deviceName>CPAP Replacement Elbow</deviceName>
    <manufacturerName>TECHO INFO LTD</manufacturerName>
    <manufacturerSrn>UK-MF-000048031</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM-ML1009</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:24:37.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906118133505</udiDi>
    <basicUdiDi>890611813YM-ML10037K</basicUdiDi>
    <tradeName>CPAP Replacement Frame</tradeName>
    <deviceName>CPAP Replacement Frame</deviceName>
    <manufacturerName>TECHO INFO LTD</manufacturerName>
    <manufacturerSrn>UK-MF-000048031</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM-ML1003</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:24:33.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906118133482</udiDi>
    <basicUdiDi>890611813YM-ML10027H</basicUdiDi>
    <tradeName>CPAP Replacement Mask Cushion</tradeName>
    <deviceName>CPAP Replacement Mask Cushion</deviceName>
    <manufacturerName>TECHO INFO LTD</manufacturerName>
    <manufacturerSrn>UK-MF-000048031</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM-ML1002</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:24:32.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975519160037</udiDi>
    <basicUdiDi>697551916NOCV8</basicUdiDi>
    <tradeName>Disposable Nasal Oxygen Cannula</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NOC-Infant-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:55:05.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>10620974003608</udiDi>
    <basicUdiDi>6209741423241517149A</basicUdiDi>
    <tradeName>Oxy2Pro Plus</tradeName>
    <deviceName>Oxy2Pro</deviceName>
    <manufacturerName>Southmedic Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000005669</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRP-2110-MDT</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:01.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>20884521761893</udiDi>
    <basicUdiDi>0763000B00000406S</basicUdiDi>
    <tradeName>20884521761893</tradeName>
    <deviceName>CO2 SAMPLE LINE INTUBATED</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010204</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION TUBINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MVAI100U</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:46:20.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>20884521761909</udiDi>
    <basicUdiDi>0763000B00000406S</basicUdiDi>
    <tradeName>20884521761909</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010204</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION TUBINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MVAIL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:46:19.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>20884521761985</udiDi>
    <basicUdiDi>0763000B00000406S</basicUdiDi>
    <tradeName>20884521761985</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010204</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION TUBINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MVIIH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:46:19.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435412906275</udiDi>
    <basicUdiDi>84354129909U</basicUdiDi>
    <tradeName>Alargadera de oxígeno 7 m</tradeName>
    <deviceName>Alargadera de oxígeno</deviceName>
    <manufacturerName>Material clínico y sanitario, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000016772</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010204</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION TUBINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0000555</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:30:01.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033003260456</udiDi>
    <basicUdiDi>803300326101000006KB</basicUdiDi>
    <tradeName>08033003260456</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIAB S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000005988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010206</emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OS/50P</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:21:24.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033003260449</udiDi>
    <basicUdiDi>803300326101000006KB</basicUdiDi>
    <tradeName>08033003260449</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIAB S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000005988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010206</emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OS/50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:10:37.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975519160952</udiDi>
    <basicUdiDi>697551916NKNST7</basicUdiDi>
    <tradeName>16975519160952</tradeName>
    <deviceName>Disposable Nebulizer Mask</deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</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>AB pazarı için değil</deviceStatus>
    <reference>Adult-S-6(non sterile)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:46:20.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975519160914</udiDi>
    <basicUdiDi>697551916OMNSTQ</basicUdiDi>
    <tradeName>16975519160914</tradeName>
    <deviceName>Disposable Oxygen Mask</deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Adult-S-02(non sterile)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:46:18.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975519160587</udiDi>
    <basicUdiDi>697551916NOCNSSX</basicUdiDi>
    <tradeName>16975519160587</tradeName>
    <deviceName>Disposable Nasal Oxygen Cannula</deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NOC-Infant-14(non sterile)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:46:17.702Z</lastUpdated>
  </row>
</eudamedExport>