<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04961333247318</udiDi>
    <basicUdiDi>4961333036500ZW</basicUdiDi>
    <tradeName>Nasometer</tradeName>
    <deviceName>Nasometer</deviceName>
    <manufacturerName>PENTAX of America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008135</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:20.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333235438</udiDi>
    <basicUdiDi>4961333033950cTU</basicUdiDi>
    <tradeName>3950c Visi-Pitch</tradeName>
    <deviceName>3950c Visi-Pitch</deviceName>
    <manufacturerName>PENTAX of America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008135</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3950c</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:08.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>08023279312300</udiDi>
    <basicUdiDi>802327900V0302088700100BL</basicUdiDi>
    <tradeName>DIAPASON LEGA 128 VD - con pesi</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GIMA SPA</manufacturerName>
    <manufacturerSrn>IT-MF-000011004</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31230</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:34:07.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>08023279312256</udiDi>
    <basicUdiDi>802327900V0302088700020BM</basicUdiDi>
    <tradeName>DIAPASON IN ALLUMINIO 128 Hz</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GIMA SPA</manufacturerName>
    <manufacturerSrn>IT-MF-000011004</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31225</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:34:05.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060534899476</udiDi>
    <basicUdiDi>5060534899476YP</basicUdiDi>
    <tradeName>Clonallon Sclera Marker</tradeName>
    <deviceName>Clonallon Sclera Marker</deviceName>
    <manufacturerName>Clonallon Laboratories Ltd</manufacturerName>
    <manufacturerSrn>XI-MF-000002896</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLON-01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:23:05.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333235445</udiDi>
    <basicUdiDi>4961333034500bSG</basicUdiDi>
    <tradeName>Computerized Speech Lab (CSL) 4500b</tradeName>
    <deviceName>Computerized Speech Lab (CSL) 4500b</deviceName>
    <manufacturerName>PENTAX of America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008135</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4500b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:36.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200449</udiDi>
    <basicUdiDi>137013302ECH002KP1XXKW</basicUdiDi>
    <tradeName>Kit tube acoustique</tradeName>
    <deviceName>Accessoires Echodia</deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:23:43.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200371</udiDi>
    <basicUdiDi>137013302ECH001KP1XXKH</basicUdiDi>
    <tradeName>BABYSCREEN</tradeName>
    <deviceName>ELIOS</deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:23:42.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200616</udiDi>
    <basicUdiDi>137013302ECH002KP1000VP</basicUdiDi>
    <tradeName>Kit 26 bouchons mousse</tradeName>
    <deviceName>Accessoires Echodia kit bouchons</deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:18:27.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200432</udiDi>
    <basicUdiDi>137013302ECH002KP1XXKW</basicUdiDi>
    <tradeName>Stimulateur acoustique double inserts</tradeName>
    <deviceName>Accessoires Echodia</deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:18:26.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200364</udiDi>
    <basicUdiDi>137013302ECH001KP1XXKH</basicUdiDi>
    <tradeName>ELIOS</tradeName>
    <deviceName>ELIOS</deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:18:19.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200142</udiDi>
    <basicUdiDi>137013302ECH0003KP1XXWD</basicUdiDi>
    <tradeName>AUDIOBLUE</tradeName>
    <deviceName>AUDIOBLUE</deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH003</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:18:17.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200388</udiDi>
    <basicUdiDi>137013302ECH001KP1XXKH</basicUdiDi>
    <tradeName>ECHOSCAN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:51:52.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200395</udiDi>
    <basicUdiDi>137013302ECH001KP1XXKH</basicUdiDi>
    <tradeName>AUDIOSMART</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:51:52.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200401</udiDi>
    <basicUdiDi>137013302ECH001KP1XXKH</basicUdiDi>
    <tradeName>AUDIOSCHOOL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:51:51.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200418</udiDi>
    <basicUdiDi>137013302ECH001KP1XXKH</basicUdiDi>
    <tradeName>OTOWIN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:51:51.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200456</udiDi>
    <basicUdiDi>137013302ECH002KP1XXKW</basicUdiDi>
    <tradeName>Casque d'audiométrie osseuse (vibrateur osseux B71)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:51:51.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200463</udiDi>
    <basicUdiDi>137013302ECH002KP1XXKW</basicUdiDi>
    <tradeName>Sonde d'otoémission ECHO-OAE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:51:51.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200470</udiDi>
    <basicUdiDi>137013302ECH002KP1XXKW</basicUdiDi>
    <tradeName>Stimulateur de masque controlatéral</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:51:51.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701330200487</udiDi>
    <basicUdiDi>137013302ECH002KP1XXKW</basicUdiDi>
    <tradeName>4 pinces détachables électrophysiologie</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ELECTRONIQUE DU MAZET</manufacturerName>
    <manufacturerSrn>FR-MF-000001805</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:51:51.858Z</lastUpdated>
  </row>
</eudamedExport>