<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04056839134207</udiDi>
    <basicUdiDi>B-04056839134207</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 30 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>10990802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:11.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134191</udiDi>
    <basicUdiDi>B-04056839134191</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 40 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>10990788</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:09.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134184</udiDi>
    <basicUdiDi>B-04056839134184</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 40 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>10990787</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:07.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134177</udiDi>
    <basicUdiDi>B-04056839134177</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 40 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>10990786</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:05.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134160</udiDi>
    <basicUdiDi>B-04056839134160</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 40 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>10990785</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:04.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134153</udiDi>
    <basicUdiDi>B-04056839134153</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 60 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>10990784</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:03.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134146</udiDi>
    <basicUdiDi>B-04056839134146</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 60 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>10990783</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:13:00.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134139</udiDi>
    <basicUdiDi>B-04056839134139</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 60 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>10990782</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:12:59.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134122</udiDi>
    <basicUdiDi>B-04056839134122</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 60 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>10990781</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:12:58.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134115</udiDi>
    <basicUdiDi>B-04056839134115</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 80 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>10990780</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:12:56.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134108</udiDi>
    <basicUdiDi>B-04056839134108</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 80 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>10990779</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:12:54.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839133958</udiDi>
    <basicUdiDi>B-04056839133958</basicUdiDi>
    <tradeName>SET DEMO M-CORE CROS R-LI GNT</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>Piyasada</deviceStatus>
    <reference>10986411</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:12:52.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839133941</udiDi>
    <basicUdiDi>B-04056839133941</basicUdiDi>
    <tradeName>SET M-CORE CROS R-LI GR</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>Piyasada</deviceStatus>
    <reference>10986410</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:12:52.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839134092</udiDi>
    <basicUdiDi>B-04056839134092</basicUdiDi>
    <tradeName>S_ITE M-CORE IX-CIC 80 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>10990777</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:12:50.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839133934</udiDi>
    <basicUdiDi>B-04056839133934</basicUdiDi>
    <tradeName>SET M-CORE CROS R-LI GNT</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>Piyasada</deviceStatus>
    <reference>10986409</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:12:48.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839133927</udiDi>
    <basicUdiDi>B-04056839133927</basicUdiDi>
    <tradeName>SET M-CORE CROS R-LI RGD</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>Piyasada</deviceStatus>
    <reference>10986408</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:12:32.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839133910</udiDi>
    <basicUdiDi>B-04056839133910</basicUdiDi>
    <tradeName>SET M-CORE CROS R-LI DKC</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>Piyasada</deviceStatus>
    <reference>10986407</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:12:32.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839133903</udiDi>
    <basicUdiDi>B-04056839133903</basicUdiDi>
    <tradeName>SET M-CORE CROS R-LI PRL</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>Piyasada</deviceStatus>
    <reference>10986406</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:12:31.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839133897</udiDi>
    <basicUdiDi>B-04056839133897</basicUdiDi>
    <tradeName>SET M-CORE CROS R-LI SB</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>Piyasada</deviceStatus>
    <reference>10986405</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:12:30.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839133880</udiDi>
    <basicUdiDi>B-04056839133880</basicUdiDi>
    <tradeName>SET M-CORE CROS R-LI BLK</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>Piyasada</deviceStatus>
    <reference>10986404</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:12:26.424Z</lastUpdated>
  </row>
</eudamedExport>