<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>15060753520035</udiDi>
    <basicUdiDi>506075352GEN2OTOAB</basicUdiDi>
    <tradeName>Tympa Otoscope System (Samsung A40)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tympa Health Technologies Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000042174</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THA4002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:03:27.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060753520097</udiDi>
    <basicUdiDi>506075352GEN2OTOAB</basicUdiDi>
    <tradeName>Tympa Otoscope System (iPhone 13)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tympa Health Technologies Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000042174</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THi1302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:03:27.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977473890008</udiDi>
    <basicUdiDi>697747389OtoscopeTB</basicUdiDi>
    <tradeName>06977473890008</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Soundlink Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000043038</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149099</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SOT100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:37:39.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975918770885</udiDi>
    <basicUdiDi>697591877ES11SW</basicUdiDi>
    <tradeName>06975918770885</tradeName>
    <deviceName>Ear Syringe</deviceName>
    <manufacturerName>NANJING IHOME COMFORT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000037214</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ear Syringe 8ml</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:25:00.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975918770656</udiDi>
    <basicUdiDi>697591877NS09VA</basicUdiDi>
    <tradeName>06975918770656</tradeName>
    <deviceName>Nasal Suction</deviceName>
    <manufacturerName>NANJING IHOME COMFORT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000037214</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149099</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHCF1030</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:24:42.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975773654900</udiDi>
    <basicUdiDi>697577365OSD01UC</basicUdiDi>
    <tradeName>06975773654900</tradeName>
    <deviceName>Otoscope(Including Tip Dispensor)</deviceName>
    <manufacturerName>Foshan Any Home Care Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041905</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149099</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHC-OT01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:45:41.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974439670339</udiDi>
    <basicUdiDi>6974439670353EZ</basicUdiDi>
    <tradeName>LCD Monitor</tradeName>
    <deviceName>LCD Monitor</deviceName>
    <manufacturerName>Nanjing Tuge Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018925</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149010</emdnCode>
    <emdnDescription>VOICE DISPLAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TG-S26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:07:35.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974415288893</udiDi>
    <basicUdiDi>697441528oto4Y</basicUdiDi>
    <tradeName>06974415288893</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>ZHEJIANG NEW VISION IMP. &amp; EXP. CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048749</manufacturerSrn>
    <authorisedRepresentativeName>REP Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025090</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Otoscope</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:58:51.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972727560072</udiDi>
    <basicUdiDi>697272756ZTVS0163</basicUdiDi>
    <tradeName>VertiSVV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai ZEHNIT Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013234</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>007/ZT-SVV-I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:08:20.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972727560041</udiDi>
    <basicUdiDi>697272756ZTVG0249</basicUdiDi>
    <tradeName>VertiGoggles</tradeName>
    <deviceName>Vestibular function assessment device</deviceName>
    <manufacturerName>Shanghai ZEHNIT Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013234</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:08:20.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972727560003</udiDi>
    <basicUdiDi>697272756ZTVM0155</basicUdiDi>
    <tradeName>VertiMobile</tradeName>
    <deviceName>Eye Movement Recording Goggles</deviceName>
    <manufacturerName>Shanghai ZEHNIT Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013234</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:08:16.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972545091000</udiDi>
    <basicUdiDi>697254509OTOSCOPETY</basicUdiDi>
    <tradeName>06972545091000</tradeName>
    <deviceName>OTOSCOPE</deviceName>
    <manufacturerName>Zhejiang Honsun Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000039480</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS-OT10</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:59:04.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971919461708</udiDi>
    <basicUdiDi>697191946EO4R</basicUdiDi>
    <tradeName>06971919461708</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Ningbo Albert Novosino Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008571</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OS811</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:22:39.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975633110010</udiDi>
    <basicUdiDi>697058187EJ001EQ</basicUdiDi>
    <tradeName>06975633110010</tradeName>
    <deviceName>Otoscopes</deviceName>
    <manufacturerName>Tonglu Sike Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051027</manufacturerSrn>
    <authorisedRepresentativeName>endodoctor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050606</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EJ2001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:32:30.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315000768</udiDi>
    <basicUdiDi>5713315NA000765R</basicUdiDi>
    <tradeName>05713315000768</tradeName>
    <deviceName>1066 Astera2 Accessories - Software</deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-49-90600</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:50:58.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117243871</udiDi>
    <basicUdiDi>5711117_P-0000129_RB</basicUdiDi>
    <tradeName>RadioEar IP30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8601097</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:47:46.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117228779</udiDi>
    <basicUdiDi>5711117_P-0000506_RL</basicUdiDi>
    <tradeName>DD65v2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8520327</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:47:42.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117228717</udiDi>
    <basicUdiDi>5711117_P-0000505_RH</basicUdiDi>
    <tradeName>DD450</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8520308</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:47:41.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117230802</udiDi>
    <basicUdiDi>5711117_P-0000556_02_YN</basicUdiDi>
    <tradeName>Sanibel EARturtle Universal Box of 36 kits w/tab electrodes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-PR-000031217</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140385</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8537209</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:47:40.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117230796</udiDi>
    <basicUdiDi>5711117_P-0000403_R4</basicUdiDi>
    <tradeName>Sanibel EARturtle Universal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140385</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8537206</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:47:40.141Z</lastUpdated>
  </row>
</eudamedExport>