<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04251778107538</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>317571302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:37.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251778107545</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>305574302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:37.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251778107552</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>318571302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:37.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251778107569</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>306574302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:37.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251778107576</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>306572302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:37.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251778107583</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>306573302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:37.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251778107590</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>319571302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:37.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251778107606</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>307574302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:37.631Z</lastUpdated>
  </row>
  <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>05903060603073</udiDi>
    <basicUdiDi>B-05903060603073</basicUdiDi>
    <tradeName>Bobotic Forte</tradeName>
    <deviceName>Bobotic Forte</deviceName>
    <manufacturerName>Zakłady Farmaceutyczne Polpharma SA</manufacturerName>
    <manufacturerSrn>PL-MF-000010601</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>WBOB-0200-000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T21:22:40.314Z</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-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-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-1001090747</udiDi>
    <basicUdiDi>B-1001090747</basicUdiDi>
    <tradeName>Luvos Gastrosan Reizdarm</tradeName>
    <deviceName>Irritable Bowel Syndrome</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</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>10010907</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T11:50:08.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1001090645</udiDi>
    <basicUdiDi>B-1001090645</basicUdiDi>
    <tradeName>Luvos Gastrosan Durchfall</tradeName>
    <deviceName>Anti Diarrhea</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</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>10010906</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T11:50:08.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100095AG</udiDi>
    <basicUdiDi>B-ITMF0000247100095AG</basicUdiDi>
    <tradeName>PEG BIOMA</tradeName>
    <deviceName>BIEFFE LAX</deviceName>
    <manufacturerName>Biofarma S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000024710</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>NA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:42:02.655Z</lastUpdated>
  </row>
</eudamedExport>