<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04056839136522</udiDi>
    <basicUdiDi>B-04056839136522</basicUdiDi>
    <tradeName>S_ITE AMPLI-MINI I 4MC 10STD R TRD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10991700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:55.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839136515</udiDi>
    <basicUdiDi>B-04056839136515</basicUdiDi>
    <tradeName>S_ITE AMPLI-MINI I 3MC 10STD R TRD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10991701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:54.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839136508</udiDi>
    <basicUdiDi>B-04056839136508</basicUdiDi>
    <tradeName>S_ITE AMPLI-CROS I MC 10STD L TBLU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10991710</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:53.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839136478</udiDi>
    <basicUdiDi>B-04056839136478</basicUdiDi>
    <tradeName>S_ITE AMPLI-MINI I MC 10STDD R TRD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10991713</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:49.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839136492</udiDi>
    <basicUdiDi>B-04056839136492</basicUdiDi>
    <tradeName>S_ITE AMPLI-CROS I MC 10STD R TRD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10991711</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:48.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839136485</udiDi>
    <basicUdiDi>B-04056839136485</basicUdiDi>
    <tradeName>S_ITE AMPLI-MINI I MC 10STDD L TBLU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10991712</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:48.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839135785</udiDi>
    <basicUdiDi>B-04056839135785</basicUdiDi>
    <tradeName>HA AMPLI-ENERGY R MC D</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060102</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10990462</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:32.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134337</udiDi>
    <basicUdiDi>B-04056839134337</basicUdiDi>
    <tradeName>S_ITE M-CORE CROS IX-CIC MOC TRD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10990816</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:31.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134320</udiDi>
    <basicUdiDi>B-04056839134320</basicUdiDi>
    <tradeName>S_ITE M-CORE CROS IX-CIC BLK TRD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10990815</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:30.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134313</udiDi>
    <basicUdiDi>B-04056839134313</basicUdiDi>
    <tradeName>S_ITE M-CORE CROS IX-CIC MOC TBLU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10990814</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:28.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134306</udiDi>
    <basicUdiDi>B-04056839134306</basicUdiDi>
    <tradeName>S_ITE M-CORE CROS IX-CIC BLK TBLU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10990813</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:26.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134290</udiDi>
    <basicUdiDi>B-04056839134290</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC SDEMO BLK TRD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10990812</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:24.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134283</udiDi>
    <basicUdiDi>B-04056839134283</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC SDEMO BLK TBLU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10990811</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:24.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134276</udiDi>
    <basicUdiDi>B-04056839134276</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 20 MOC TRD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10990810</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:22.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134269</udiDi>
    <basicUdiDi>B-04056839134269</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 20 BLK TRD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10990809</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:20.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134252</udiDi>
    <basicUdiDi>B-04056839134252</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 20 MOC TBLU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10990808</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:18.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134245</udiDi>
    <basicUdiDi>B-04056839134245</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 20 BLK TBLU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10990806</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:17.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134238</udiDi>
    <basicUdiDi>B-04056839134238</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 30 MOC TRD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10990805</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:16.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134221</udiDi>
    <basicUdiDi>B-04056839134221</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 30 BLK TRD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10990804</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:13.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134214</udiDi>
    <basicUdiDi>B-04056839134214</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 30 MOC TBLU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10990803</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:12.112Z</lastUpdated>
  </row>
</eudamedExport>