<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04260585411684</udiDi>
    <basicUdiDi>42605854142605854116844H</basicUdiDi>
    <tradeName>Merz Drehstuhl</tradeName>
    <deviceName>Merz Drehstuhl</deviceName>
    <manufacturerName>Merz Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010619</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>52000000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:12:00.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260585410199</udiDi>
    <basicUdiDi>42605854142605854101993W</basicUdiDi>
    <tradeName>Merz Audio</tradeName>
    <deviceName>Merz Audio</deviceName>
    <manufacturerName>Merz Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010619</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51050005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:11:57.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260381960164</udiDi>
    <basicUdiDi>426038196OhrtrichterXE</basicUdiDi>
    <tradeName>04260381960164</tradeName>
    <deviceName>Disposable Ear Funnels</deviceName>
    <manufacturerName>Luxamed GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006437</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>A5.101.144</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:54:50.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260381960010</udiDi>
    <basicUdiDi>426038196OtoskopYN</basicUdiDi>
    <tradeName>04260381960010</tradeName>
    <deviceName>LuxaScope Auris LED</deviceName>
    <manufacturerName>Luxamed GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006437</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>A1.416.114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:54:49.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250365190809</udiDi>
    <basicUdiDi>42503651ENTUnitS61CORinUD</basicUdiDi>
    <tradeName>ATMOS S 61 CORIAN instruments XXL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ATMOS MedizinTechnik GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121402</emdnCode>
    <emdnDescription>ENT TREATMENT UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>532.0900.0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:20:19.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250365174977</udiDi>
    <basicUdiDi>42503651ENTUnitS61SERinXP</basicUdiDi>
    <tradeName>ATMOS S 61 Servant instruments XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ATMOS MedizinTechnik GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121402</emdnCode>
    <emdnDescription>ENT TREATMENT UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>532.0500.0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:20:06.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250365166187</udiDi>
    <basicUdiDi>42503651ENTUnitS61SERviYL</basicUdiDi>
    <tradeName>ATMOS S 61 Servant vision</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ATMOS MedizinTechnik GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121402</emdnCode>
    <emdnDescription>ENT TREATMENT UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>531.0000.0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:20:01.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250365190762</udiDi>
    <basicUdiDi>42503651ENTUnitS61CORinUD</basicUdiDi>
    <tradeName>ATMOS S 61 CORIAN integral</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ATMOS MedizinTechnik GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121402</emdnCode>
    <emdnDescription>ENT TREATMENT UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>532.0800.0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:16:59.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250365174960</udiDi>
    <basicUdiDi>42503651ENTUnitS61SERinXP</basicUdiDi>
    <tradeName>ATMOS S 61 Servant instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ATMOS MedizinTechnik GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121402</emdnCode>
    <emdnDescription>ENT TREATMENT UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>532.2100.0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:13:25.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436035524259</udiDi>
    <basicUdiDi>843603552AAUY00101TP</basicUdiDi>
    <tradeName>Sistema Sibelsound 400 AM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SIBEL SAU</manufacturerName>
    <manufacturerSrn>ES-PR-000052577</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01379-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:59:25.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436035524266</udiDi>
    <basicUdiDi>843603552AAUY00101TP</basicUdiDi>
    <tradeName>Sistema Sibelsound 400 AO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SIBEL SAU</manufacturerName>
    <manufacturerSrn>ES-PR-000052577</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01380-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:59:25.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436035524273</udiDi>
    <basicUdiDi>843603552AAUY00101TP</basicUdiDi>
    <tradeName>Sistema Sibelsound 400 AOM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SIBEL SAU</manufacturerName>
    <manufacturerSrn>ES-PR-000052577</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01381-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:59:25.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436035524280</udiDi>
    <basicUdiDi>843603552AAUY00101TP</basicUdiDi>
    <tradeName>Sistema Sibelsound 400 AOM+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SIBEL SAU</manufacturerName>
    <manufacturerSrn>ES-PR-000052577</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01377-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:59:25.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436035524297</udiDi>
    <basicUdiDi>843603552AAUY00101TP</basicUdiDi>
    <tradeName>Sistema Sibelsound 400 SUPRA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SIBEL SAU</manufacturerName>
    <manufacturerSrn>ES-PR-000052577</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01376-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:59:25.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436035524310</udiDi>
    <basicUdiDi>843603552AAUY00201TU</basicUdiDi>
    <tradeName>Sistema Sibelsound DUO AOM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SIBEL SAU</manufacturerName>
    <manufacturerSrn>ES-PR-000052577</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09133-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:59:24.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049203060790</udiDi>
    <basicUdiDi>40492030000175BZ</basicUdiDi>
    <tradeName>Otoscopes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>STEMA Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005523</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>LA-000-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:59:03.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049047042358</udiDi>
    <basicUdiDi>4049047ZAO10AFA27DROZJ</basicUdiDi>
    <tradeName>AlphaScope™</tradeName>
    <deviceName>Laryngoscope, Otoscope and Accessories</deviceName>
    <manufacturerName>Gimmi GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005445</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>E.8187.11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:52:37.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>04035873070719</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>8300058412</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:28:37.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000811129</udiDi>
    <basicUdiDi>0763000B00007968Q</basicUdiDi>
    <tradeName>00763000811129</tradeName>
    <deviceName>AxiEM ENT Instruments</deviceName>
    <manufacturerName>Medtronic Navigation Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000014543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140580</emdnCode>
    <emdnDescription>STEREOTACTIC ENT SURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9734378</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:46:40.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>00732094011944</udiDi>
    <basicUdiDi>0732094GMN901001EG</basicUdiDi>
    <tradeName>Welch Allyn</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
    <authorisedRepresentativeName>Welch Allyn Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000768</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24400-U</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:45:58.918Z</lastUpdated>
  </row>
</eudamedExport>