<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05745000311187</udiDi>
    <basicUdiDi>5745000311ATM4TW</basicUdiDi>
    <tradeName>Oscilla® A50 w. H210A headset</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Oscilla A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000002784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1233</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:29.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000311194</udiDi>
    <basicUdiDi>5745000311ATM4TW</basicUdiDi>
    <tradeName>Oscilla® A60 w. DD65 headset</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Oscilla A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000002784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1237</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:29.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000311200</udiDi>
    <basicUdiDi>5745000311ATM4TW</basicUdiDi>
    <tradeName>Oscilla® A60 w. H210A headset</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Oscilla A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000002784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1239</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:29.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711781001258</udiDi>
    <basicUdiDi>05711781DHF2009ZW</basicUdiDi>
    <tradeName>Entomed SA204</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Auditdata A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000011415</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA204</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:49:41.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711781002705</udiDi>
    <basicUdiDi>05711781DHF2000ZC</basicUdiDi>
    <tradeName>Unity 4, Measure</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Auditdata A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000011415</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100.310</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:49:41.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711781001685</udiDi>
    <basicUdiDi>05711781DHF2000ZC</basicUdiDi>
    <tradeName>Primus Fitting Unit +</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Auditdata A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000011415</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90.3013</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:49:38.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711781001241</udiDi>
    <basicUdiDi>05711781DHF2009ZW</basicUdiDi>
    <tradeName>Entomed SA203</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Auditdata A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000011415</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA203</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:49:33.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711781001234</udiDi>
    <basicUdiDi>05711781DHF2009ZW</basicUdiDi>
    <tradeName>Entomed SA202</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Auditdata A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000011415</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA202</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:49:30.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711781001227</udiDi>
    <basicUdiDi>05711781DHF2009ZW</basicUdiDi>
    <tradeName>Entomed SA201</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Auditdata A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000011415</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA201</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:49:28.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711781001098</udiDi>
    <basicUdiDi>05711781DHF2000ZC</basicUdiDi>
    <tradeName>Primus Ice</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Auditdata A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000011415</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90.3030</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:49:27.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711781001050</udiDi>
    <basicUdiDi>05711781DHF2000ZC</basicUdiDi>
    <tradeName>2000 Primus Fitting Unit Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Auditdata A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000011415</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90.3029</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:49:26.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260223140877</udiDi>
    <basicUdiDi>0426022Sentiero-199</basicUdiDi>
    <tradeName>Patient button</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006935</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100343</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:45:15.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260223141720</udiDi>
    <basicUdiDi>0426022Sentiero-199</basicUdiDi>
    <tradeName>Live speech microphone MIC-01</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006935</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100779</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:45:15.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260223143267</udiDi>
    <basicUdiDi>0426022Earphones-17Q</basicUdiDi>
    <tradeName>Insert Ear Phone Tip 18 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006935</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100900-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:45:14.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260223147579</udiDi>
    <basicUdiDi>0426022Earphones-17Q</basicUdiDi>
    <tradeName>Infant Ear Tip 4mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006935</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100905-P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:44:53.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260223147586</udiDi>
    <basicUdiDi>0426022Earphones-17Q</basicUdiDi>
    <tradeName>Infant Ear Tip 3.5mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006935</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100906-P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:44:53.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262365080028</udiDi>
    <basicUdiDi>42623650813496452590000JJ</basicUdiDi>
    <tradeName>AT2000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AURITEC Medizindiagnostische Systeme GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023154</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10710001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:53:43.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>08054187380358</udiDi>
    <basicUdiDi>805418738AU1PE5</basicUdiDi>
    <tradeName>Piccolo Basic Aero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INVENTIS S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10328</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:19:54.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>08054187380365</udiDi>
    <basicUdiDi>805418738AU1PE5</basicUdiDi>
    <tradeName>Piccolo Plus Aero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INVENTIS S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:19:54.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>08054187380372</udiDi>
    <basicUdiDi>805418738AU1PE5</basicUdiDi>
    <tradeName>Piccolo Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INVENTIS S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10329</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:19:54.840Z</lastUpdated>
  </row>
</eudamedExport>