<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FT.CE.107.FA.6.24S7</udiDi>
    <basicUdiDi>B-FT.CE.107.FA.6.24S7</basicUdiDi>
    <tradeName>REFLUSEN PLUS M</tradeName>
    <deviceName>REFLUSEN PLUS M</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</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>FT.CE.107.FA.6.24</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:12:34.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FA.6.12RY</udiDi>
    <basicUdiDi>B-FT.CE.107.FA.6.12RY</basicUdiDi>
    <tradeName>REFLUSEN PLUS M</tradeName>
    <deviceName>REFLUSEN PLUS M</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</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>FT.CE.107.FA.6.12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:12:33.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FA.5.12RR</udiDi>
    <basicUdiDi>B-FT.CE.107.FA.5.12RR</basicUdiDi>
    <tradeName>ACID-EAZE PLUS</tradeName>
    <deviceName>ACID-EAZE PLUS</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</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>FT.CE.107.FA.5.12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:12:29.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FA.4.CAMPP8</udiDi>
    <basicUdiDi>B-FT.CE.107.FA.4.CAMPP8</basicUdiDi>
    <tradeName>REFALTEX</tradeName>
    <deviceName>REFALTEX</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</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>Artık piyasada değil</deviceStatus>
    <reference>FT.CE.107</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:12:28.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FA.4.24RR</udiDi>
    <basicUdiDi>B-FT.CE.107.FA.4.24RR</basicUdiDi>
    <tradeName>REFALTEX</tradeName>
    <deviceName>REFALTEX</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</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>Artık piyasada değil</deviceStatus>
    <reference>FT.CE.107</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:12:27.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FA.4.12RJ</udiDi>
    <basicUdiDi>B-FT.CE.107.FA.4.12RJ</basicUdiDi>
    <tradeName>REFALTEX</tradeName>
    <deviceName>REFALTEX</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</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>Artık piyasada değil</deviceStatus>
    <reference>FT.CE.107</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:12:26.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FA.1.CAMPMZ</udiDi>
    <basicUdiDi>B-FT.CE.107.FA.1.CAMPMZ</basicUdiDi>
    <tradeName>REFLUSEN PLUS</tradeName>
    <deviceName>REFLUSEN PLUS</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</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>FT.CE.107</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:12:22.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FA.1.24R4</udiDi>
    <basicUdiDi>B-FT.CE.107.FA.1.24R4</basicUdiDi>
    <tradeName>REFLUSEN PLUS</tradeName>
    <deviceName>REFLUSEN PLUS</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</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>FT.CE.107</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:12:22.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.2.LWN.campB4</udiDi>
    <basicUdiDi>B-FT.CE.107.2.LWN.campB4</basicUdiDi>
    <tradeName>REFLU MAG</tradeName>
    <deviceName>REFLU MAG</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</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>Artık piyasada değil</deviceStatus>
    <reference>FT.CE.107.FG.2.LWN.camp</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:12:21.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FR-MF-0000156003R</udiDi>
    <basicUdiDi>B-FR-MF-0000156003R</basicUdiDi>
    <tradeName>ForlaxGo</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>1057887</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:39:27.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ESPUMIP5</udiDi>
    <basicUdiDi>B-ESPUMIP5</basicUdiDi>
    <tradeName>ESPUMIX BABY</tradeName>
    <deviceName>ESPUMIX BABY</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>06008085</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:02:44.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DiosmectitepowderY6</udiDi>
    <basicUdiDi>B-DiosmectitepowderY6</basicUdiDi>
    <tradeName>Diosmectite powder</tradeName>
    <deviceName>Diosmectite powder</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>GC10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:19:10.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DM001ESTspIT/V26</udiDi>
    <basicUdiDi>B-DM001ESTspIT/V26</basicUdiDi>
    <tradeName>ESTORIAL gel orale</tradeName>
    <deviceName>ESTORIAL gel orale</deviceName>
    <manufacturerName>FENIX PHARMA SOCIETA' COOPERATIVA</manufacturerName>
    <manufacturerSrn>IT-MF-000027868</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>DM001ESTsp</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:10:21.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DM001ESTcmIT/VSJ</udiDi>
    <basicUdiDi>B-DM001ESTcmIT/VSJ</basicUdiDi>
    <tradeName>ESTORIAL</tradeName>
    <deviceName>Estorial compresse masticabili</deviceName>
    <manufacturerName>FENIX PHARMA SOCIETA' COOPERATIVA</manufacturerName>
    <manufacturerSrn>IT-MF-000027868</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>DM001ESTcmIT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:10:19.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DM001ARCcmSP/VFL</udiDi>
    <basicUdiDi>B-DM001ARCcmSP/VFL</basicUdiDi>
    <tradeName>ARCID comprimidos masticables</tradeName>
    <deviceName>ARCID comprimidos masticables</deviceName>
    <manufacturerName>FENIX PHARMA SOCIETA' COOPERATIVA</manufacturerName>
    <manufacturerSrn>IT-MF-000027868</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>DM001ARCcmSP/V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:10:19.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DM001ARC/VE8</udiDi>
    <basicUdiDi>B-DM001ARC/VE8</basicUdiDi>
    <tradeName>ARCID COMPRIMIDOS PARA MASTIGAR</tradeName>
    <deviceName>ARCID COMPRIMIDOS PARA MASTIGAR</deviceName>
    <manufacturerName>FENIX PHARMA SOCIETA' COOPERATIVA</manufacturerName>
    <manufacturerSrn>IT-MF-000027868</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>DM001ARC/V</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:10:17.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DIGETOP3S</udiDi>
    <basicUdiDi>B-DIGETOP3S</basicUdiDi>
    <tradeName>D-DIGETOP3S</tradeName>
    <deviceName>DIGETOP</deviceName>
    <manufacturerName>Levante srl</manufacturerName>
    <manufacturerSrn>IT-MF-000036829</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2128</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:08:34.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BXMEDEM79</udiDi>
    <basicUdiDi>B-BXMEDEM79</basicUdiDi>
    <tradeName>ALINAN COLIC AND BLOATING (emulsion)</tradeName>
    <deviceName>BALONIX MED (emulsion)</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>BXMEDEM</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:30:21.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BXMED3B</udiDi>
    <basicUdiDi>B-BXMED3B</basicUdiDi>
    <tradeName>BALONIX MED chewable tablets</tradeName>
    <deviceName>BALONIX MED (chewable tablets)</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>BXMED</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:30:19.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-976400SP</udiDi>
    <basicUdiDi>B-976400SP</basicUdiDi>
    <tradeName>ZirkulinDurchfall</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>976400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:59:05.009Z</lastUpdated>
  </row>
</eudamedExport>