<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09421901970703</udiDi>
    <basicUdiDi>942190197070NZ3230-100PE</basicUdiDi>
    <tradeName>Ear Specula - 6mm</tradeName>
    <deviceName>Ear Specula - 6mm</deviceName>
    <manufacturerName>Adept Medical Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000003374</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NZ3230-100</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:14:40.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421901970697</udiDi>
    <basicUdiDi>942190197069NZ3232-52F</basicUdiDi>
    <tradeName>Ear Specula - 4mm</tradeName>
    <deviceName>Ear Specula - 4mm</deviceName>
    <manufacturerName>Adept Medical Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000003374</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NZ3232-5</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:14:39.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421901970680</udiDi>
    <basicUdiDi>942190197068NZ3231-5ZG</basicUdiDi>
    <tradeName>Ear Specula - 5mm</tradeName>
    <deviceName>Ear Specula - 5mm</deviceName>
    <manufacturerName>Adept Medical Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000003374</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NZ3231-5</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:14:38.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421901970673</udiDi>
    <basicUdiDi>942190197067NZ3230-5YL</basicUdiDi>
    <tradeName>Ear Specula - 6mm</tradeName>
    <deviceName>Ear Specula - 6mm</deviceName>
    <manufacturerName>Adept Medical Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000003374</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NZ3230-5</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:14:34.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421901970611</udiDi>
    <basicUdiDi>942190197061NZ3238-100RY</basicUdiDi>
    <tradeName>Suction Controller</tradeName>
    <deviceName>Suction Controller</deviceName>
    <manufacturerName>Adept Medical Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000003374</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NZ3238-100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:14:32.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421901970475</udiDi>
    <basicUdiDi>942190197047NZ3441-100UJ</basicUdiDi>
    <tradeName>Cerumen Hook</tradeName>
    <deviceName>Cerumen Hook</deviceName>
    <manufacturerName>Adept Medical Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000003374</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NZ3441-100</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:14:26.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421901970451</udiDi>
    <basicUdiDi>942190197045NZ3431-100S7</basicUdiDi>
    <tradeName>Jobson Horne Probe</tradeName>
    <deviceName>Jobson Horne Probe</deviceName>
    <manufacturerName>Adept Medical Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000003374</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NZ3431-100</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:14:21.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>09348227000016</udiDi>
    <basicUdiDi>93482270VHWBPSLRK9</basicUdiDi>
    <tradeName>VorOtek O Scope - SpecFrame 2D</tradeName>
    <deviceName>VorOtek Scopes and Lights Range</deviceName>
    <manufacturerName>Vorotek Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002859</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VSOS-2D</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:35.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>08711757236223</udiDi>
    <basicUdiDi>87117572362236V</basicUdiDi>
    <tradeName>Wapiti Hoestsiroop 250 ml NL/Fr</tradeName>
    <deviceName>Wapiti Hoestsiroop 250 ml NL/FR</deviceName>
    <manufacturerName>Emonta B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000049904</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>056201</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:18:11.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>08711757223162</udiDi>
    <basicUdiDi>871175722316262</basicUdiDi>
    <tradeName>Wapiti Hoestsiroop 150 ml</tradeName>
    <deviceName>Wapiti Hoestsiroop 150 ml</deviceName>
    <manufacturerName>Emonta B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000049904</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>056102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:18:10.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>08711757222004</udiDi>
    <basicUdiDi>871175722200458</basicUdiDi>
    <tradeName>Wapiti Hoestsiroop 250 ml</tradeName>
    <deviceName>Wapiti Hoestsiroop 250 ml</deviceName>
    <manufacturerName>Emonta B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000049904</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>056101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:18:08.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859911004702</udiDi>
    <basicUdiDi>859911004LightedForcep87</basicUdiDi>
    <tradeName>Lighted Forceps</tradeName>
    <deviceName>Lighted Forceps</deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2750</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:00:53.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859911004429</udiDi>
    <basicUdiDi>859911004SafeCurettesZF</basicUdiDi>
    <tradeName>Safe Ear Curettes</tradeName>
    <deviceName>Safe Ear Curette</deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1222</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:00:52.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>00714646000873</udiDi>
    <basicUdiDi>859911004LightedCuretteKH</basicUdiDi>
    <tradeName>Lighted Ear Curette</tradeName>
    <deviceName>Lighted Curettes</deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3340</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:00:40.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053614630004</udiDi>
    <basicUdiDi>805848125BroncositolXY</basicUdiDi>
    <tradeName>BRONCOSITOL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LO.LI. PHARMA S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000023734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BRONCOSITOL</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:00:38.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>08054042880061</udiDi>
    <basicUdiDi>805404288MEOTDH</basicUdiDi>
    <tradeName>08054042880061</tradeName>
    <deviceName>KIT OTORINOLARINGOIATRIA ED ACCESSORI</deviceName>
    <manufacturerName>Cam Hospital srl</manufacturerName>
    <manufacturerSrn>IT-MF-000033797</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-OT-XXX</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:00:02.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053300890835</udiDi>
    <basicUdiDi>805330089TD12AFTAC9</basicUdiDi>
    <tradeName>MILROSINA + AFTAS GEL</tradeName>
    <deviceName>AFTABLOCK</deviceName>
    <manufacturerName>ALMA s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000029690</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AI64000001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:41:18.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052990631063</udiDi>
    <basicUdiDi>805299063LARI001JQ</basicUdiDi>
    <tradeName>Angineel Própolis</tradeName>
    <deviceName>Throat Spray</deviceName>
    <manufacturerName>Nirial Pharma srl</manufacturerName>
    <manufacturerSrn>IT-MF-000018760</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19408</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:40:17.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055510241438</udiDi>
    <basicUdiDi>805044485100020072</basicUdiDi>
    <tradeName>TONIMER AEROSOL FLACONCINI MONODOSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche</manufacturerName>
    <manufacturerSrn>IT-MF-000027942</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I48V02460</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:35:01.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033638951187</udiDi>
    <basicUdiDi>803363895CO0015R</basicUdiDi>
    <tradeName>KAROS GOLA PASTIGLIE</tradeName>
    <deviceName>Orodispersible Tablets HA + Carbomer + Xanthan Gum</deviceName>
    <manufacturerName>IBSA FARMACEUTICI ITALIA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000008111</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8033638951187</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:08:47.724Z</lastUpdated>
  </row>
</eudamedExport>