<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>111599965385</udiDi>
    <basicUdiDi>PP07498KPRO16</basicUdiDi>
    <tradeName>KIJIMEA® REIZDARM PRO</tradeName>
    <deviceName>KIJIMEA® REIZDARM PRO</deviceName>
    <manufacturerName>Synformulas GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</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>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:32:58.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>111388025018</udiDi>
    <basicUdiDi>PP07498KREG88</basicUdiDi>
    <tradeName>KIJIMEA® REGULARIS</tradeName>
    <deviceName>KIJIMEA®  REGULARIS</deviceName>
    <manufacturerName>Synformulas GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</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>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:32:54.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SmectaGODV</udiDi>
    <basicUdiDi>B-SmectaGODV</basicUdiDi>
    <tradeName>SmectaGo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MAYOLY PHARMA FRANCE</manufacturerName>
    <manufacturerSrn>FR-MF-000015600</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>SmectaGo</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:48:57.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SNMED6Y</udiDi>
    <basicUdiDi>B-SNMED6Y</basicUdiDi>
    <tradeName>STOPTRANS MED (powder for oral suspension - sachets)</tradeName>
    <deviceName>STOPTRANS MED (powder for oral suspension - sachets 4g)</deviceName>
    <manufacturerName>Fiterman Pharma SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001410</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>SNMED</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:51.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ONLIGOLBY</udiDi>
    <basicUdiDi>B-ONLIGOLBY</basicUdiDi>
    <tradeName>ONLIGOL</tradeName>
    <deviceName>ONLIGOL</deviceName>
    <manufacturerName>S.I.I.T. srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022188</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>2605274</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:15:09.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-LXMED6R</udiDi>
    <basicUdiDi>B-LXMED6R</basicUdiDi>
    <tradeName>LAXIT MED (powder for oral solution - sachets 5g)</tradeName>
    <deviceName>LAXIT MED (powder for oral solution - sachets 5g)</deviceName>
    <manufacturerName>Fiterman Pharma SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001410</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>LXMED</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:53:31.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-LXMED10GW7</udiDi>
    <basicUdiDi>B-LXMED10GW7</basicUdiDi>
    <tradeName>LAXIT MED (powder for oral solution - sachets 10g)</tradeName>
    <deviceName>LAXIT MED (powder for oral solution - sachets 10g)</deviceName>
    <manufacturerName>Fiterman Pharma SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001410</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>LXMED10G</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:53:27.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KRPRO7G</udiDi>
    <basicUdiDi>B-KRPRO7G</basicUdiDi>
    <tradeName>KIJIMEA® REIZDARM PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synformulas GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:47:40.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KRMEZ</udiDi>
    <basicUdiDi>B-KRMEZ</basicUdiDi>
    <tradeName>KIJIMEA® REIZMAGEN</tradeName>
    <deviceName>KIJIMEA® REIZMAGEN</deviceName>
    <manufacturerName>Synformulas GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016381</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>Artık piyasada değil</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:47:38.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KREGP2</udiDi>
    <basicUdiDi>B-KREGP2</basicUdiDi>
    <tradeName>KIJIMEA® REGULARIS</tradeName>
    <deviceName>KIJIMEA® REGULARIS</deviceName>
    <manufacturerName>Synformulas GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016381</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>Artık piyasada değil</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:47:38.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR8K</udiDi>
    <basicUdiDi>B-KR8K</basicUdiDi>
    <tradeName>KIJIMEA® REIZDARM</tradeName>
    <deviceName>KIJIMEA® REIZDARM</deviceName>
    <manufacturerName>Synformulas GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016381</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>Artık piyasada değil</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:47:34.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100063A3</udiDi>
    <basicUdiDi>B-ITMF0000247100063A3</basicUdiDi>
    <tradeName>Dulcosoft Irregolarità e Gonfiore</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>2026-07-13T23:03:47.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF00002471000629Z</udiDi>
    <basicUdiDi>B-ITMF00002471000629Z</basicUdiDi>
    <tradeName>Dulcosoft Irregolarità e Gonfiore</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>2026-07-13T23:03:45.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF00002471000619X</udiDi>
    <basicUdiDi>B-ITMF00002471000619X</basicUdiDi>
    <tradeName>DulcoSoft Plus</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>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:03:43.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF00002471000609V</udiDi>
    <basicUdiDi>B-ITMF00002471000609V</basicUdiDi>
    <tradeName>DulcoSoft Plus</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>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:03:41.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100059AC</udiDi>
    <basicUdiDi>B-ITMF0000247100059AC</basicUdiDi>
    <tradeName>DulcoSoft Plus</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>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:03:41.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100055A4</udiDi>
    <basicUdiDi>B-ITMF0000247100055A4</basicUdiDi>
    <tradeName>Refluzen</tradeName>
    <deviceName>GASTRO STOP</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>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:03:37.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100054A2</udiDi>
    <basicUdiDi>B-ITMF0000247100054A2</basicUdiDi>
    <tradeName>Refluzen</tradeName>
    <deviceName>GASTRO STOP</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>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:03:35.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF00002471000539Y</udiDi>
    <basicUdiDi>B-ITMF00002471000539Y</basicUdiDi>
    <tradeName>Maalox RefluProtect Suspension</tradeName>
    <deviceName>GASTRO STOP</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>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:03:34.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF00002471000529W</udiDi>
    <basicUdiDi>B-ITMF00002471000529W</basicUdiDi>
    <tradeName>Maalox RefluProtect Suspension</tradeName>
    <deviceName>GASTRO STOP</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>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:03:33.104Z</lastUpdated>
  </row>
</eudamedExport>