<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04251778107613</udiDi>
    <basicUdiDi>42517781MD339D8</basicUdiDi>
    <tradeName>Rifluduo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>307572302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:37.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251778107620</udiDi>
    <basicUdiDi>42517781MD339D8</basicUdiDi>
    <tradeName>Rifluduo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>307573302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:37.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251778107637</udiDi>
    <basicUdiDi>42517781MD339D8</basicUdiDi>
    <tradeName>Reloxan</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>320571302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:37.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251778107651</udiDi>
    <basicUdiDi>42517781MD339D8</basicUdiDi>
    <tradeName>Reloxan</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>308572302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:37.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251778107668</udiDi>
    <basicUdiDi>42517781MD339D8</basicUdiDi>
    <tradeName>Reloxan</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>308573302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:37.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251778110897</udiDi>
    <basicUdiDi>42517781MD323CR</basicUdiDi>
    <tradeName>Abtei Husten Saft mit Honig und Eibisch</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030199</emdnCode>
    <emdnDescription>NASOPHARYNGEAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9532116</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:04:47.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD258UG</udiDi>
    <basicUdiDi>B-MD258UG</basicUdiDi>
    <tradeName>Ozovit® MP</tradeName>
    <deviceName>Ozovit® MP</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0010902</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:30:52.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD230TS</udiDi>
    <basicUdiDi>B-MD230TS</basicUdiDi>
    <tradeName>Coldamaris  protect  Augentropfen</tradeName>
    <deviceName>Eyeleen Eye Drops</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030299</emdnCode>
    <emdnDescription>OPHTHALMOLOGY, LIQUID FLUIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112015</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:30:50.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD168UE</udiDi>
    <basicUdiDi>B-MD168UE</basicUdiDi>
    <tradeName>Vagiflor</tradeName>
    <deviceName>Vagiflor</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30010413</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:30:49.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD152TX</udiDi>
    <basicUdiDi>B-MD152TX</basicUdiDi>
    <tradeName>Fructosin</tradeName>
    <deviceName>Fructosin</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>161904</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:30:48.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD148U8</udiDi>
    <basicUdiDi>B-MD148U8</basicUdiDi>
    <tradeName>Iovir Throat Spray</tradeName>
    <deviceName>Coldamaris Throat Spray</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030199</emdnCode>
    <emdnDescription>NASOPHARYNGEAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P360A09</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:30:45.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD147U6</udiDi>
    <basicUdiDi>B-MD147U6</basicUdiDi>
    <tradeName>QUIXX protect</tradeName>
    <deviceName>Coldamaris Lozenges</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030199</emdnCode>
    <emdnDescription>NASOPHARYNGEAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9435</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:30:44.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD132TR</udiDi>
    <basicUdiDi>B-MD132TR</basicUdiDi>
    <tradeName>Mastu® Zäpfchen</tradeName>
    <deviceName>Mastu® Zäpfchen</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G05</emdnCode>
    <emdnDescription>TOPICAL ANORECTAL ADMINISTERED GASTRO-INTESTINAL SYSTEM DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>175555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:30:43.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD153TZ</udiDi>
    <basicUdiDi>B-MD153TZ</basicUdiDi>
    <tradeName>tetesept Sodbrennen Akut</tradeName>
    <deviceName>tetesept Sodbrennen Akut</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11652</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:06:20.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD131TP</udiDi>
    <basicUdiDi>B-MD131TP</basicUdiDi>
    <tradeName>Mastu® Salbe</tradeName>
    <deviceName>Mastu® Salbe</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G05</emdnCode>
    <emdnDescription>TOPICAL ANORECTAL ADMINISTERED GASTRO-INTESTINAL SYSTEM DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>175554</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:06:19.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD108TU</udiDi>
    <basicUdiDi>B-MD108TU</basicUdiDi>
    <tradeName>tetesept Hals &amp; Rachen Akut Spray</tradeName>
    <deviceName>tetesept Hals und Rachen Spray</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030199</emdnCode>
    <emdnDescription>NASOPHARYNGEAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200002203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:06:18.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD107TS</udiDi>
    <basicUdiDi>B-MD107TS</basicUdiDi>
    <tradeName>tetesept Nasen Heilsalbe</tradeName>
    <deviceName>tetesept Nasen Heilsalbe</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030199</emdnCode>
    <emdnDescription>NASOPHARYNGEAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44588</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:06:18.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD102TG</udiDi>
    <basicUdiDi>B-MD102TG</basicUdiDi>
    <tradeName>tetesept Wund- &amp;  Heilsalbe</tradeName>
    <deviceName>tetesept Wund- &amp; Heilsalbe</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22375</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:06:13.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD106TQ</udiDi>
    <basicUdiDi>B-MD106TQ</basicUdiDi>
    <tradeName>tetesept Anginosan Halstabletten</tradeName>
    <deviceName>tetesept Anginosan Halstabletten Kirsche / Zitrone</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030199</emdnCode>
    <emdnDescription>NASOPHARYNGEAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21649</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:06:11.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD103TJ</udiDi>
    <basicUdiDi>B-MD103TJ</basicUdiDi>
    <tradeName>tetesept Pflanzlicher Reizhusten Stiller Saft</tradeName>
    <deviceName>tetesept Reizhusten Liquid / Sticks</deviceName>
    <manufacturerName>HÄLSA Pharma GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030199</emdnCode>
    <emdnDescription>NASOPHARYNGEAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200002070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:06:11.011Z</lastUpdated>
  </row>
</eudamedExport>