<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06973574190085</udiDi>
    <basicUdiDi>697357419NP01PB</basicUdiDi>
    <tradeName>Earwax removal and ear examination tools</tradeName>
    <deviceName>Earwax removal and ear examination tools</deviceName>
    <manufacturerName>Wudao Pu (Shenzhen) Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000056790</manufacturerSrn>
    <authorisedRepresentativeName>Debao International GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046097</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:09:09.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971355353063</udiDi>
    <basicUdiDi>697135535305694</basicUdiDi>
    <tradeName>Single Use Sheath</tradeName>
    <deviceName>Single Use Sheath</deviceName>
    <manufacturerName>Shenzhen Besdata Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000018921</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-BS001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:59:50.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117227550</udiDi>
    <basicUdiDi>5711117_P-0000498_SY</basicUdiDi>
    <tradeName>Sanibel REM Probe Tubes</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>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8533301</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:07:05.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117199659</udiDi>
    <basicUdiDi>5711117_P-0000495_SP</basicUdiDi>
    <tradeName>Sanibel Pediatric OAE  foam ear tips</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>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8102682</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:07:03.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117026504</udiDi>
    <basicUdiDi>5711117_P-0000501_R5</basicUdiDi>
    <tradeName>Sanibel Assortment Box BET25</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>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8012838</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:06:55.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971355353070</udiDi>
    <basicUdiDi>697135535305694</basicUdiDi>
    <tradeName>Single Use Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Besdata Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000018921</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-BS002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:44:57.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971355353087</udiDi>
    <basicUdiDi>697135535305694</basicUdiDi>
    <tradeName>Single Use Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Besdata Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000018921</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-BS003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:44:57.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971355353094</udiDi>
    <basicUdiDi>697135535305694</basicUdiDi>
    <tradeName>Single Use Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Besdata Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000018921</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-BS004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:44:56.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851289007330</udiDi>
    <basicUdiDi>0851289007DE508QR</basicUdiDi>
    <tradeName>00851289007330</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Firefly Global</manufacturerName>
    <manufacturerSrn>US-MF-000020015</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE508</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:34:29.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851289007101</udiDi>
    <basicUdiDi>0851289007DE570QW</basicUdiDi>
    <tradeName>00851289007101</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Firefly Global</manufacturerName>
    <manufacturerSrn>US-MF-000020015</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE570</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:34:02.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851289007064</udiDi>
    <basicUdiDi>0851289007DE500Q9</basicUdiDi>
    <tradeName>00851289007064</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Firefly Global</manufacturerName>
    <manufacturerSrn>US-MF-000020015</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:56.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851289007019</udiDi>
    <basicUdiDi>0851289007DE550QQ</basicUdiDi>
    <tradeName>00851289007019</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Firefly Global</manufacturerName>
    <manufacturerSrn>US-MF-000020015</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE550</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:49.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022464621</udiDi>
    <basicUdiDi>0850022464HearOAETC</basicUdiDi>
    <tradeName>hearOAE</tradeName>
    <deviceName>hearOAE</deviceName>
    <manufacturerName>hearX SA (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000031452</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149001</emdnCode>
    <emdnDescription>OTOACOUSTIC EMISSIONS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>None</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:51.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318190376</udiDi>
    <basicUdiDi>0842318160516UN</basicUdiDi>
    <tradeName>Pro Fit Fitting Software</tradeName>
    <deviceName>Pro Fit Fitting Software</deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>60516-000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:19:03.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318131171</udiDi>
    <basicUdiDi>0842318160945VH</basicUdiDi>
    <tradeName>My Starkey Mobile App</tradeName>
    <deviceName>My Starkey Mobile App</deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>My Starkey</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:18:49.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318130808</udiDi>
    <basicUdiDi>0842318161475V8</basicUdiDi>
    <tradeName>Thrive Software</tradeName>
    <deviceName>Thrive Software Application</deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:18:45.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318117175</udiDi>
    <basicUdiDi>0842318160211TV</basicUdiDi>
    <tradeName>Starkey Inspire X Fitting Software</tradeName>
    <deviceName>Inspire Fitting Software</deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>60211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:18:45.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925027787</udiDi>
    <basicUdiDi>0821925000215B</basicUdiDi>
    <tradeName>00821925027787</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDFS100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:43:41.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817020020075</udiDi>
    <basicUdiDi>08172002M010300EP</basicUdiDi>
    <tradeName>USB Jr Duet</tradeName>
    <deviceName>USB Jr Duet</deviceName>
    <manufacturerName>Intelligent Hearing Systems Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000011473</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149001</emdnCode>
    <emdnDescription>OTOACOUSTIC EMISSIONS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M010300</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:26:41.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340077905000</udiDi>
    <basicUdiDi>0734007791003TP</basicUdiDi>
    <tradeName>Disposable Ear Speculum 2,5 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hammarplast Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000009420</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>31110</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:01:41.556Z</lastUpdated>
  </row>
</eudamedExport>