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<eudamedExport entity="devices">
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    <basicUdiDi>471989020OSCK93XUE</basicUdiDi>
    <tradeName>Fibre Diagnostic Otoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHIN KOU MEDICAL INSTRUMENT CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000042725</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-938A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:11.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719890209412</udiDi>
    <basicUdiDi>471989020OSCK93XUE</basicUdiDi>
    <tradeName>Fibre Diagnostic Otoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHIN KOU MEDICAL INSTRUMENT CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000042725</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-939A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:10.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719890209429</udiDi>
    <basicUdiDi>471989020OSCK93XUE</basicUdiDi>
    <tradeName>Radiantlite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHIN KOU MEDICAL INSTRUMENT CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000042725</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-S908</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:10.080Z</lastUpdated>
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  <row>
    <udiDi>04048551196342</udiDi>
    <basicUdiDi>4048551001441TM</basicUdiDi>
    <tradeName>04048551196342</tradeName>
    <deviceName>Probes/Bougies/Dilators</deviceName>
    <manufacturerName>KARL STORZ SE &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005723</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745708</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:26:56.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048551196502</udiDi>
    <basicUdiDi>4048551001447TZ</basicUdiDi>
    <tradeName>04048551196502</tradeName>
    <deviceName>Probes/Bougies/Dilators</deviceName>
    <manufacturerName>KARL STORZ SE &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005723</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745847</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:26:54.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>04035873011422</udiDi>
    <basicUdiDi>4035873120101029S</basicUdiDi>
    <tradeName>OTOSCOPES</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Henke-Sass, Wolf GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005531</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>89550240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T14:23:02.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770025150000</udiDi>
    <basicUdiDi>3770025150LOGAUDIOPODV7</basicUdiDi>
    <tradeName>iAudiogram®</tradeName>
    <deviceName>AudioPod®</deviceName>
    <manufacturerName>MY MEDICAL ASSISTANT</manufacturerName>
    <manufacturerSrn>FR-MF-000019847</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149092</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iAudiogram®</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:06:30.311Z</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>
  <row>
    <udiDi>06947752802558</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>ER02.140.WA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:01:45.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947752802541</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>ER34.100.WA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:01:44.398Z</lastUpdated>
  </row>
</eudamedExport>