<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04711605995344</udiDi>
    <basicUdiDi>471160599AIF0143</basicUdiDi>
    <tradeName>Insufflation Filter with Tubing Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Medical Design Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000019772</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040199</emdnCode>
    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>AIF-400Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:38:11.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711605995382</udiDi>
    <basicUdiDi>471160599AIF0143</basicUdiDi>
    <tradeName>Insufflation Filter with Tubing Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Medical Design Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000019772</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040199</emdnCode>
    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>AIF-403Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:38:11.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711605995450</udiDi>
    <basicUdiDi>471160599AIF0143</basicUdiDi>
    <tradeName>INSUFFLATION TUBING WITH FILTER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Medical Design Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000019772</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040199</emdnCode>
    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NL-41020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:38:10.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841737101352</udiDi>
    <basicUdiDi>B-00841737101352</basicUdiDi>
    <tradeName>00841737101352</tradeName>
    <deviceName>Precision Flow Heliox Unit</deviceName>
    <manufacturerName>Vapotherm Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006231</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PFH-UNIT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:44:46.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841737101369</udiDi>
    <basicUdiDi>B-00841737101369</basicUdiDi>
    <tradeName>Precision Flow</tradeName>
    <deviceName>Precision Flow Plus</deviceName>
    <manufacturerName>Vapotherm Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006231</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF-PLUS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:44:45.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841737100140</udiDi>
    <basicUdiDi>B-00841737100140</basicUdiDi>
    <tradeName>00841737100140</tradeName>
    <deviceName>Precision Flow Unit</deviceName>
    <manufacturerName>Vapotherm Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006231</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF-UNIT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:44:42.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498368587</udiDi>
    <basicUdiDi>B-00619498368587</basicUdiDi>
    <tradeName>S9/AIR10 FILTER,HYPO,50 PACK</tradeName>
    <deviceName>S9/Air10 Hypoallergenic Filters,AirMini Hypoallergenic Filters,Air11 Hypoallergenic Filter</deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040199</emdnCode>
    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36858</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:21:02.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498368570</udiDi>
    <basicUdiDi>B-00619498368570</basicUdiDi>
    <tradeName>S9/AIR10 FILTER,HYPO,12 PACK</tradeName>
    <deviceName>S9/Air10 Hypoallergenic Filters,AirMini Hypoallergenic Filters,Air11 Hypoallergenic Filter</deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040199</emdnCode>
    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36857</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:21:02.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498368563</udiDi>
    <basicUdiDi>B-00619498368563</basicUdiDi>
    <tradeName>S9/AIR10 FILTER,HYPO,2 PACK</tradeName>
    <deviceName>S9/Air10 Hypoallergenic Filters,AirMini Hypoallergenic Filters,Air11 Hypoallergenic Filter</deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040199</emdnCode>
    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36856</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:20:58.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906118133574</udiDi>
    <basicUdiDi>890611813YM-ML10177W</basicUdiDi>
    <tradeName>Heated Respiratory Humidifier</tradeName>
    <deviceName>Heated Respiratory Humidifier</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>R040102</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM-ML1017</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:44:21.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904428744954</udiDi>
    <basicUdiDi>89044287BRS4P</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Tube Cleaning Brush</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EA91071</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:33:33.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120209511</udiDi>
    <basicUdiDi>8902120B013RN</basicUdiDi>
    <tradeName>HME FILTER</tradeName>
    <deviceName>Disposable Heat and Moisture Exchange Bacterial/Viral Filter</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040102</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2095</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:11.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095204245</udiDi>
    <basicUdiDi>890209520424EB</basicUdiDi>
    <tradeName>Breathing Circuit &amp; Accessories (Bain Circuit, Ventilator Circuit, HME Filter)</tradeName>
    <deviceName>Breathing Circuit &amp; Accessories (Bain Circuit, Ventilator Circuit, HME Filter)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040199</emdnCode>
    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20424</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:09.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>08721008511030</udiDi>
    <basicUdiDi>87210085110purinoxsamplK9</basicUdiDi>
    <tradeName>PURINOX HME</tradeName>
    <deviceName>PURINOX HME Sample</deviceName>
    <manufacturerName>PurinoxHME B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000030680</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PURINOX HME Sample</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:13:39.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299993303</udiDi>
    <basicUdiDi>87202999933purinoxhmeJ4</basicUdiDi>
    <tradeName>PURINOX HME</tradeName>
    <deviceName>PURINOX HME</deviceName>
    <manufacturerName>PurinoxHME B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000030680</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PURINOX HME</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:53:38.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>86988638307398</udiDi>
    <basicUdiDi>869886383T202401PQ</basicUdiDi>
    <tradeName>86988638307398</tradeName>
    <deviceName>BACTERIAL AND HMEF FILTERS</deviceName>
    <manufacturerName>TMS MEDİKAL PLASTİK ÜRÜNLERİ SANAYİ VE DIŞ TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000019237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T202401</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:50:50.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203201032</udiDi>
    <basicUdiDi>42502032PRI0244N</basicUdiDi>
    <tradeName>PRIMEDIAIR ® -VO2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:44:31.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203201049</udiDi>
    <basicUdiDi>42502032PRI0244N</basicUdiDi>
    <tradeName>PRIMEDIAIR ® -DUAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21065</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:44:31.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203201056</udiDi>
    <basicUdiDi>42502032PRI0244N</basicUdiDi>
    <tradeName>PRIMEDIAIR ® -VO1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21066</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:44:31.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436593200039</udiDi>
    <basicUdiDi>84365932000396H</basicUdiDi>
    <tradeName>SANITY PROTECT II PLUS-AZ</tradeName>
    <deviceName>SANITY PROTECT II PLUS-AZ</deviceName>
    <manufacturerName>SANITY HEALTH S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000014604</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:54:44.362Z</lastUpdated>
  </row>
</eudamedExport>