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    <tradeName>S_ITE AB HORIZON 5X L 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>10980998</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:08:20.484Z</lastUpdated>
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    <udiDi>04056839123522</udiDi>
    <basicUdiDi>B-04056839123522</basicUdiDi>
    <tradeName>S_ITE AB HORIZON 5X L CIC MOC TBLU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10980999</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:08:16.461Z</lastUpdated>
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    <udiDi>04056839123515</udiDi>
    <basicUdiDi>B-04056839123515</basicUdiDi>
    <tradeName>S_ITE AB HORIZON 3X L 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>10981000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:08:15.687Z</lastUpdated>
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    <udiDi>04056839123508</udiDi>
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    <tradeName>S_ITE AB HORIZON 3X L 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>10981001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:08:14.865Z</lastUpdated>
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    <udiDi>04056839123492</udiDi>
    <basicUdiDi>B-04056839123492</basicUdiDi>
    <tradeName>S_ITE AB HORIZON SDEMO DX L 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>10981002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:08:14.059Z</lastUpdated>
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  <row>
    <udiDi>04056839123485</udiDi>
    <basicUdiDi>B-04056839123485</basicUdiDi>
    <tradeName>S_ITE AB HORIZON 7X R 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>10981015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:08:10.054Z</lastUpdated>
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    <udiDi>04056839123478</udiDi>
    <basicUdiDi>B-04056839123478</basicUdiDi>
    <tradeName>S_ITE AB HORIZON 7X R 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>10981016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:08:09.269Z</lastUpdated>
  </row>
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    <udiDi>04056839123461</udiDi>
    <basicUdiDi>B-04056839123461</basicUdiDi>
    <tradeName>S_ITE AB HORIZON 5X R 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>10981017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:08:08.464Z</lastUpdated>
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    <udiDi>04056839123454</udiDi>
    <basicUdiDi>B-04056839123454</basicUdiDi>
    <tradeName>S_ITE AB HORIZON 5X R 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>10981018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:08:07.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839123447</udiDi>
    <basicUdiDi>B-04056839123447</basicUdiDi>
    <tradeName>S_ITE AB HORIZON 3X R 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>10981019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:08:03.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839123430</udiDi>
    <basicUdiDi>B-04056839123430</basicUdiDi>
    <tradeName>S_ITE AB HORIZON 3X R 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>10981020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:08:02.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839123423</udiDi>
    <basicUdiDi>B-04056839123423</basicUdiDi>
    <tradeName>S_ITE AB HORIZON SDEMO DX 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>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10981021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:08:02.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056839122969</udiDi>
    <basicUdiDi>B-04056839122969</basicUdiDi>
    <tradeName>KIT M-CORE R-LI 80 EU 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>Artık piyasada değil</deviceStatus>
    <reference>10980446</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:08:01.279Z</lastUpdated>
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  <row>
    <udiDi>04056839122952</udiDi>
    <basicUdiDi>B-04056839122952</basicUdiDi>
    <tradeName>KIT M-CORE R-LI 80 EU 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>Artık piyasada değil</deviceStatus>
    <reference>10980447</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:07:57.238Z</lastUpdated>
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    <udiDi>04056839122945</udiDi>
    <basicUdiDi>B-04056839122945</basicUdiDi>
    <tradeName>KIT M-CORE R-LI 80 EU RGD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Y2145060102</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10980448</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:07:56.450Z</lastUpdated>
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    <udiDi>04056839122938</udiDi>
    <basicUdiDi>B-04056839122938</basicUdiDi>
    <tradeName>KIT M-CORE R-LI 80 EU DKC</tradeName>
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    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <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>10980449</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:07:55.654Z</lastUpdated>
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    <udiDi>04056839122921</udiDi>
    <basicUdiDi>B-04056839122921</basicUdiDi>
    <tradeName>KIT M-CORE R-LI 80 EU PRL</tradeName>
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    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Y2145060102</emdnCode>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10980450</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:07:54.852Z</lastUpdated>
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    <udiDi>04056839122914</udiDi>
    <basicUdiDi>B-04056839122914</basicUdiDi>
    <tradeName>KIT M-CORE R-LI 80 EU SB</tradeName>
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    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Y2145060102</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10980451</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:07:50.864Z</lastUpdated>
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    <udiDi>04056839122907</udiDi>
    <basicUdiDi>B-04056839122907</basicUdiDi>
    <tradeName>KIT M-CORE R-LI 80 EU SLV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sivantos GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Y2145060102</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10980452</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:07:50.050Z</lastUpdated>
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    <udiDi>04056839122891</udiDi>
    <basicUdiDi>B-04056839122891</basicUdiDi>
    <tradeName>KIT M-CORE R-LI 80 EU DBR</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>10980453</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:07:49.256Z</lastUpdated>
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