<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03700659401056</udiDi>
    <basicUdiDi>B-03700659401056</basicUdiDi>
    <tradeName>S.Box Duo S</tradeName>
    <deviceName>S.Box Duo S</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-116413</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:27:00.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659401032</udiDi>
    <basicUdiDi>B-03700659401032</basicUdiDi>
    <tradeName>S.Box Duo ST</tradeName>
    <deviceName>S.Box Duo ST</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-116414</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:26:59.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659400776</udiDi>
    <basicUdiDi>B-03700659400776</basicUdiDi>
    <tradeName>EcoStar</tradeName>
    <deviceName>EcoStar</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-115900</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:26:58.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659400301</udiDi>
    <basicUdiDi>B-03700659400301</basicUdiDi>
    <tradeName>GoodKnight H2O</tradeName>
    <deviceName>GoodKnight H2O (GKH2O)</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-114600</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:26:53.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659491040</udiDi>
    <basicUdiDi>3700659416809R</basicUdiDi>
    <tradeName>Sefam Access Pro</tradeName>
    <deviceName>Sefam Access Pro</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019082</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-116800</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:29:04.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659491026</udiDi>
    <basicUdiDi>3700659420208G</basicUdiDi>
    <tradeName>Sefam Connect</tradeName>
    <deviceName>Sefam Connect</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019082</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-120200</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:29:04.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659401179</udiDi>
    <basicUdiDi>3700659417029A</basicUdiDi>
    <tradeName>Néa Duo ST</tradeName>
    <deviceName>Néa Duo</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-117014</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:29:03.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659400943</udiDi>
    <basicUdiDi>3700659415609E</basicUdiDi>
    <tradeName>Sefam Analyze</tradeName>
    <deviceName>Sefam Analyze</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019082</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-215630-04</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:29:02.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659400912</udiDi>
    <basicUdiDi>3700659416429H</basicUdiDi>
    <tradeName>Humidificateur Chauffant S.Box</tradeName>
    <deviceName>Humidificateur Chauffant S.Box</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-216430-06</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:28:58.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659400875</udiDi>
    <basicUdiDi>37006594170198</basicUdiDi>
    <tradeName>Néa H2O</tradeName>
    <deviceName>Néa H2O</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-217030-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:28:57.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659400868</udiDi>
    <basicUdiDi>3700659416409D</basicUdiDi>
    <tradeName>S.Box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-116412</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:28:56.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659400899</udiDi>
    <basicUdiDi>3700659416709N</basicUdiDi>
    <tradeName>PolyLink</tradeName>
    <deviceName>PolyLink</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-116700</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:28:56.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659400004</udiDi>
    <basicUdiDi>37006594170096</basicUdiDi>
    <tradeName>Néa Info</tradeName>
    <deviceName>Néa</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-117011</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:28:40.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659401223</udiDi>
    <basicUdiDi>3700659417029A</basicUdiDi>
    <tradeName>Néa Duo S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-12T10:23:29.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659401193</udiDi>
    <basicUdiDi>3700659417029A</basicUdiDi>
    <tradeName>Ventea ST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-12T10:23:28.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659401186</udiDi>
    <basicUdiDi>3700659417029A</basicUdiDi>
    <tradeName>Ventea S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-12T10:23:28.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659401162</udiDi>
    <basicUdiDi>37006594170198</basicUdiDi>
    <tradeName>Reve H2O</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-12T10:23:25.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659401155</udiDi>
    <basicUdiDi>37006594170096</basicUdiDi>
    <tradeName>Reve Auto</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-12T10:23:25.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659401148</udiDi>
    <basicUdiDi>37006594170096</basicUdiDi>
    <tradeName>Reve Info</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-12T10:23:24.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659401117</udiDi>
    <basicUdiDi>37006594170096</basicUdiDi>
    <tradeName>Néa Auto</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-12T10:23:23.402Z</lastUpdated>
  </row>
</eudamedExport>