<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03665389000385</udiDi>
    <basicUdiDi>3665389ONIRIS8X</basicUdiDi>
    <tradeName>ONIRIS PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>oniris</manufacturerName>
    <manufacturerSrn>FR-MF-000014182</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONIPLUSIET2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:24:39.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684190120018</udiDi>
    <basicUdiDi>868419012SDCV4AIRPAP3S</basicUdiDi>
    <tradeName>NEFES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEFES MEDIKAL TEKNOLOJI SAN.TIC.LTD.STI</manufacturerName>
    <manufacturerSrn>TR-MF-000038588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AirPAPCPAP</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:23:25.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436570232183</udiDi>
    <basicUdiDi>84365702328TE</basicUdiDi>
    <tradeName>LEFT SAM·MAS KIT</tradeName>
    <deviceName>SAM·MAS MANDIBULAR ADVANCEMENT SELECTOR</deviceName>
    <manufacturerName>VEC MEDICAL SPAIN, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002992</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28001_L-kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:41:41.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435389813453</udiDi>
    <basicUdiDi>84353898APNIA-INTRORALAR</basicUdiDi>
    <tradeName>08435389813453</tradeName>
    <deviceName>APNIA INTRAORAL DEVICE</deviceName>
    <manufacturerName>B.T.I. BIOTECHNOLOGY INSTITUTE, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000001701</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTI DIA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:57:50.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426059000556</udiDi>
    <basicUdiDi>8426059RESP8A</basicUdiDi>
    <tradeName>RESPIPLUS 12U</tradeName>
    <deviceName>RESPIPLUS</deviceName>
    <manufacturerName>MARTÍNEZ LLENAS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002286</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>395129.6</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:01:54.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052590430004</udiDi>
    <basicUdiDi>805259043AIROBT</basicUdiDi>
    <tradeName>08052590430004</tradeName>
    <deviceName>AIRO ANTISNORING</deviceName>
    <manufacturerName>QReverse Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000052072</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QRS.P.0.000.00.A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:32:16.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649996144362</udiDi>
    <basicUdiDi>7649996144100304ZL</basicUdiDi>
    <tradeName>SomnoDent Fusion Flex</tradeName>
    <deviceName>SomnoDent Fusion Flex</deviceName>
    <manufacturerName>SomnoMed Philippines Inc.</manufacturerName>
    <manufacturerSrn>PH-MF-000039693</manufacturerSrn>
    <authorisedRepresentativeName>SOMNOMED FRANCE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000020732</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1117211</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:55:39.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649996144355</udiDi>
    <basicUdiDi>7649996144100303ZJ</basicUdiDi>
    <tradeName>SomnoDent Fusion Classic</tradeName>
    <deviceName>SomnoDent Fusion Classic</deviceName>
    <manufacturerName>SomnoMed Philippines Inc.</manufacturerName>
    <manufacturerSrn>PH-MF-000039693</manufacturerSrn>
    <authorisedRepresentativeName>SOMNOMED FRANCE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000020732</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SomnoDent Fusion Classic</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:55:39.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649996144348</udiDi>
    <basicUdiDi>7649996144100302ZG</basicUdiDi>
    <tradeName>SomnoDent Flex</tradeName>
    <deviceName>SomnoDent Flex</deviceName>
    <manufacturerName>SomnoMed Philippines Inc.</manufacturerName>
    <manufacturerSrn>PH-MF-000039693</manufacturerSrn>
    <authorisedRepresentativeName>SOMNOMED FRANCE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000020732</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1116211</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:55:20.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649996144331</udiDi>
    <basicUdiDi>7649996144100301ZE</basicUdiDi>
    <tradeName>SomnoDent Classic</tradeName>
    <deviceName>SomnoDent Classic</deviceName>
    <manufacturerName>SomnoMed Philippines Inc.</manufacturerName>
    <manufacturerSrn>PH-MF-000039693</manufacturerSrn>
    <authorisedRepresentativeName>SOMNOMED FRANCE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000020732</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1115111</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:55:19.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649996144324</udiDi>
    <basicUdiDi>7649996144100201Z9</basicUdiDi>
    <tradeName>SomnoDent Avant</tradeName>
    <deviceName>SomnoDent Avant</deviceName>
    <manufacturerName>SomnoMed Philippines Inc.</manufacturerName>
    <manufacturerSrn>PH-MF-000039693</manufacturerSrn>
    <authorisedRepresentativeName>SOMNOMED FRANCE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000020732</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1151211</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:55:18.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649996144072</udiDi>
    <basicUdiDi>7649996144100251ZQ</basicUdiDi>
    <tradeName>07649996144072</tradeName>
    <deviceName>Virtus</deviceName>
    <manufacturerName>SomnoMed Philippines Inc.</manufacturerName>
    <manufacturerSrn>PH-MF-000039693</manufacturerSrn>
    <authorisedRepresentativeName>SOMNOMED FRANCE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000020732</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1155211</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:55:18.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649996144034</udiDi>
    <basicUdiDi>7649996144100403ZP</basicUdiDi>
    <tradeName>SomnoDent Avant strap kit large</tradeName>
    <deviceName>SomnoDent Avant strap kit large</deviceName>
    <manufacturerName>SomnoMed Philippines Inc.</manufacturerName>
    <manufacturerSrn>PH-MF-000039693</manufacturerSrn>
    <authorisedRepresentativeName>SOMNOMED FRANCE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000020732</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1520011</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:55:14.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649996144027</udiDi>
    <basicUdiDi>7649996144100402ZM</basicUdiDi>
    <tradeName>SomnoDent Avant strap kit medium</tradeName>
    <deviceName>SomnoDent Avant strap kit medium</deviceName>
    <manufacturerName>SomnoMed Philippines Inc.</manufacturerName>
    <manufacturerSrn>PH-MF-000039693</manufacturerSrn>
    <authorisedRepresentativeName>SOMNOMED FRANCE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000020732</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1520021</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:55:13.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649996144010</udiDi>
    <basicUdiDi>7649996144100401ZK</basicUdiDi>
    <tradeName>07649996144010</tradeName>
    <deviceName>SomnoDent Avant strap kit small</deviceName>
    <manufacturerName>SomnoMed Philippines Inc.</manufacturerName>
    <manufacturerSrn>PH-MF-000039693</manufacturerSrn>
    <authorisedRepresentativeName>SOMNOMED FRANCE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000020732</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1520031</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:55:12.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972601010020</udiDi>
    <basicUdiDi>697260101001E2</basicUdiDi>
    <tradeName>Positive Airway Pressure Devices</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Ventmed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021194</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:42:17.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640104927518</udiDi>
    <basicUdiDi>764010492NOSNORINGBELTV8</basicUdiDi>
    <tradeName>OSCIMED Anti-snoring electronic belt, size XL-XXL</tradeName>
    <deviceName>Anti-snoring Belt</deviceName>
    <manufacturerName>Oscimed SA</manufacturerName>
    <manufacturerSrn>CH-MF-000009605</manufacturerSrn>
    <authorisedRepresentativeName>OSCIMED EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000028943</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-BLT-XLXXL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:23:19.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640104927501</udiDi>
    <basicUdiDi>764010492DENTALPROTECT2Z</basicUdiDi>
    <tradeName>SANABRUX</tradeName>
    <deviceName>Dental protector for bruxism</deviceName>
    <manufacturerName>Oscimed SA</manufacturerName>
    <manufacturerSrn>CH-MF-000009605</manufacturerSrn>
    <authorisedRepresentativeName>OSCIMED EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000028943</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-BRX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:23:17.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640104927204</udiDi>
    <basicUdiDi>764010492NASALDILATORP3</basicUdiDi>
    <tradeName>ClipAir nasal dilator 1 pack of 3 sizes</tradeName>
    <deviceName>Nasal Dilator to treat snoring</deviceName>
    <manufacturerName>Oscimed SA</manufacturerName>
    <manufacturerSrn>CH-MF-000009605</manufacturerSrn>
    <authorisedRepresentativeName>OSCIMED EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000028943</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-CLIP-3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:23:15.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640104927006</udiDi>
    <basicUdiDi>764010492SOMNOFIT8U</basicUdiDi>
    <tradeName>SOMNOFIT Mandibular advancement device</tradeName>
    <deviceName>Mandibular advancement devices</deviceName>
    <manufacturerName>Oscimed SA</manufacturerName>
    <manufacturerSrn>CH-MF-000009605</manufacturerSrn>
    <authorisedRepresentativeName>OSCIMED EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000028943</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:23:13.949Z</lastUpdated>
  </row>
</eudamedExport>