<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04056839098615</udiDi>
    <basicUdiDi>B-04056839098615</basicUdiDi>
    <tradeName>HA AB HORIZON 1X RIC 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>10997376</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:56:39.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839098608</udiDi>
    <basicUdiDi>B-04056839098608</basicUdiDi>
    <tradeName>HA AB HORIZON 1X RIC 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>10997377</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:56:35.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839098554</udiDi>
    <basicUdiDi>B-04056839098554</basicUdiDi>
    <tradeName>HA AB HORIZON 1X RIC-R 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>10997382</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:56:34.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839098547</udiDi>
    <basicUdiDi>B-04056839098547</basicUdiDi>
    <tradeName>HA AB HORIZON 1X RIC-R 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>10997383</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:56:34.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839098530</udiDi>
    <basicUdiDi>B-04056839098530</basicUdiDi>
    <tradeName>HA AB HORIZON 1X RIC-R 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>10997384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:56:33.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839098523</udiDi>
    <basicUdiDi>B-04056839098523</basicUdiDi>
    <tradeName>HA AB HORIZON 1X RIC-R SLH</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>10997385</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:56:28.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839098479</udiDi>
    <basicUdiDi>B-04056839098479</basicUdiDi>
    <tradeName>HA AB HORIZON 1X RIC-S BLK BLKG</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>10997390</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:56:27.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839098462</udiDi>
    <basicUdiDi>B-04056839098462</basicUdiDi>
    <tradeName>HA AB HORIZON 1X RIC-S SNW SNWG</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>10997391</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:56:26.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839094945</udiDi>
    <basicUdiDi>B-04056839094945</basicUdiDi>
    <tradeName>C_ITE STERLING 40 8C ITE</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>10962202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:53:24.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839094938</udiDi>
    <basicUdiDi>B-04056839094938</basicUdiDi>
    <tradeName>C_ITE STERLING 60 8C ITE</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>10962201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:53:24.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839094921</udiDi>
    <basicUdiDi>B-04056839094921</basicUdiDi>
    <tradeName>C_ITE STERLING 80 8C ITE</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>10962200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:53:22.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839091883</udiDi>
    <basicUdiDi>B-04056839091883</basicUdiDi>
    <tradeName>C_ITE STERLING 40 8C IIC</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>10961505</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:53:18.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839091876</udiDi>
    <basicUdiDi>B-04056839091876</basicUdiDi>
    <tradeName>C_ITE STERLING 60 8C IIC</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>10961504</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:53:17.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839091869</udiDi>
    <basicUdiDi>B-04056839091869</basicUdiDi>
    <tradeName>C_ITE STERLING 80 8C IIC</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>10961503</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:53:16.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839091852</udiDi>
    <basicUdiDi>B-04056839091852</basicUdiDi>
    <tradeName>C_ITE STERLING 40 8C CIC</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>10961502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:53:13.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839091845</udiDi>
    <basicUdiDi>B-04056839091845</basicUdiDi>
    <tradeName>C_ITE STERLING 60 8C CIC</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>10961501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:53:12.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839091838</udiDi>
    <basicUdiDi>B-04056839091838</basicUdiDi>
    <tradeName>C_ITE STERLING 80 8C CIC</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>10961500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:53:11.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839088449</udiDi>
    <basicUdiDi>B-04056839088449</basicUdiDi>
    <tradeName>S_ITE ADVANCE IF CROS R 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>Y214599</emdnCode>
    <emdnDescription>HEARING AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10960056</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:53:09.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839088432</udiDi>
    <basicUdiDi>B-04056839088432</basicUdiDi>
    <tradeName>S_ITE ADVANCE IF CROS L 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>Y214599</emdnCode>
    <emdnDescription>HEARING AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10960055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:53:07.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839088425</udiDi>
    <basicUdiDi>B-04056839088425</basicUdiDi>
    <tradeName>S_ITE ADVANCE IF CROS R 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>Y214599</emdnCode>
    <emdnDescription>HEARING AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10960054</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:53:05.698Z</lastUpdated>
  </row>
</eudamedExport>