<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03760364680214</udiDi>
    <basicUdiDi>376036468FRAMI-EYEX3N</basicUdiDi>
    <tradeName>Frami-EyeXplor Module Sinusoïdal</tradeName>
    <deviceName>EYEXPLOR FRAMIRAL</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRAMI-EYEX-SINU</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:35.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680191</udiDi>
    <basicUdiDi>376036468MTTBCHW</basicUdiDi>
    <tradeName>Multitest Balance Control Poussant Gauche</tradeName>
    <deviceName>Multitest Balance Control FRAMIRAL</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140402</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENTSTABILOMETRIC PLATFORMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTTBC-PL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:31.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680177</udiDi>
    <basicUdiDi>376036468HPOINT.27Q</basicUdiDi>
    <tradeName>HEAD POINTER FRAMIRAL</tradeName>
    <deviceName>HEAD POINTER FRAMIRAL</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPOINT.2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:30.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680153</udiDi>
    <basicUdiDi>376036468VERSUB-EU-PCKD</basicUdiDi>
    <tradeName>FRAMI-VS</tradeName>
    <deviceName>Vertical Subjective Framiral</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VERSUB-EU-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:29.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680146</udiDi>
    <basicUdiDi>376036468REGLED-EUHE</basicUdiDi>
    <tradeName>REGLED Vert</tradeName>
    <deviceName>REGLED FRAMIRAL</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REGLED-EU-VERT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:28.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680078</udiDi>
    <basicUdiDi>376036468FRAMAVDN4</basicUdiDi>
    <tradeName>FRAMAVD-SSF FRAMIRAL</tradeName>
    <deviceName>Acuité Visuelle Dynamique Framiral</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRAMAVD2-SSF-EU</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:24.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680054</udiDi>
    <basicUdiDi>376036468FR-KITINFO-EUSC</basicUdiDi>
    <tradeName>Kit d'informatisation du fauteuil</tradeName>
    <deviceName>Kit d'informatisation Fauteuil Rotatoire</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140480</emdnCode>
    <emdnDescription>VESTIBULAR SYSTEM ANALYSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR-KITINFO-EU</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:24.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680016</udiDi>
    <basicUdiDi>376036468FSCOPE-EUL7</basicUdiDi>
    <tradeName>Framiscope avec écran incorporé</tradeName>
    <deviceName>FRAMISCOPE-Vidéonystagmoscope FRAMIRAL</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSCOPE-EU-EI2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:22.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680061</udiDi>
    <basicUdiDi>376036468FAUTRT4-STEL</basicUdiDi>
    <tradeName>FRAMI-FAUTEUIL</tradeName>
    <deviceName>Fauteuil Rotatoire Framiral</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140403</emdnCode>
    <emdnDescription>ROTATING PENDULAR CHAIRS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAUTRT4-ST</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:38:57.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701126700030</udiDi>
    <basicUdiDi>37011267247XXXXTS</basicUdiDi>
    <tradeName>03701126700030</tradeName>
    <deviceName>Spéculum auriculaire à usage unique</deviceName>
    <manufacturerName>COMED SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000151</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24 701 25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:40:00.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970384252767</udiDi>
    <basicUdiDi>697038425OTSTV</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>HONSUN (NANTONG) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009428</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS-OT10S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T23:16:13.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970384250008</udiDi>
    <basicUdiDi>697038425OTSTV</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>HONSUN (NANTONG) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009428</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS-OT10G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T23:15:03.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>18052283200980</udiDi>
    <basicUdiDi>805228320Z12149006WD</basicUdiDi>
    <tradeName>OTOSCOPIO VETERINARIO CON ILLUMINAZIONE LED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AIESI HOSPITAL SERVICE S.a.s. di PIANTADOSI VALERIO E C</manufacturerName>
    <manufacturerSrn>IT-MF-000032617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHS792</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:11:10.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947752802626</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER34.140.WA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:02:04.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947752802619</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER33.140.WA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:02:02.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947752802602</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER329.140.WA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:01:57.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947752802596</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER32.140.WA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:01:55.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947752802589</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER04.140.WA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:01:54.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947752802572</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER03.140.WA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:01:51.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947752802565</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER029.140.WA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:01:48.022Z</lastUpdated>
  </row>
</eudamedExport>