<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FTP054_108J</udiDi>
    <basicUdiDi>B-FTP054_108J</basicUdiDi>
    <tradeName>ENDOCOL IT</tradeName>
    <deviceName>NORMOBOWELL COMPRESSE I.B.S.</deviceName>
    <manufacturerName>Labomar S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000007965</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>FTP054</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:26:34.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP054EU</udiDi>
    <basicUdiDi>B-FTP054EU</basicUdiDi>
    <tradeName>Bei Reizdarm DE, AU</tradeName>
    <deviceName>NORMOBOWELL COMPRESSE I.B.S.</deviceName>
    <manufacturerName>Labomar S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000007965</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>FTP054</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:26:33.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP036_1JR</udiDi>
    <basicUdiDi>B-FTP036_1JR</basicUdiDi>
    <tradeName>HEPILOR 4 cps IT</tradeName>
    <deviceName>Hepilor Capsule</deviceName>
    <manufacturerName>Labomar S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000007965</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>FTP036</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:25:28.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP036ES</udiDi>
    <basicUdiDi>B-FTP036ES</basicUdiDi>
    <tradeName>HEPILOR 20 cps IT</tradeName>
    <deviceName>Hepilor Capsule</deviceName>
    <manufacturerName>Labomar S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000007965</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>FTP036</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:25:27.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP035_1JL</udiDi>
    <basicUdiDi>B-FTP035_1JL</basicUdiDi>
    <tradeName>Hepilor liquido 40 ml IT</tradeName>
    <deviceName>Hepilor liquido</deviceName>
    <manufacturerName>Labomar S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000007965</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>FTP035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:25:22.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP035EQ</udiDi>
    <basicUdiDi>B-FTP035EQ</basicUdiDi>
    <tradeName>Hepilor liquido 200 ml IT</tradeName>
    <deviceName>Hepilor liquido</deviceName>
    <manufacturerName>Labomar S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000007965</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>FTP035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:25:21.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107FH.3.camp3U</udiDi>
    <basicUdiDi>B-FT.CE.107FH.3.camp3U</basicUdiDi>
    <tradeName>RILEFAST SOD</tradeName>
    <deviceName>RILEFAST SOD</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.107FH.3.camp</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:15:09.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107FH.3.24P3</udiDi>
    <basicUdiDi>B-FT.CE.107FH.3.24P3</basicUdiDi>
    <tradeName>RILEFAST SOD</tradeName>
    <deviceName>RILEFAST SOD</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.107FH.3.24</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:15:05.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107FH.3.12NU</udiDi>
    <basicUdiDi>B-FT.CE.107FH.3.12NU</basicUdiDi>
    <tradeName>RILEFAST SOD</tradeName>
    <deviceName>RILEFAST SOD</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.107FH.3.12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:15:04.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107FH.2.camp3F</udiDi>
    <basicUdiDi>B-FT.CE.107FH.2.camp3F</basicUdiDi>
    <tradeName>REFLU SOD</tradeName>
    <deviceName>REFLU SOD</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.107FH.2.camp</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:15:03.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107FH.2.24NU</udiDi>
    <basicUdiDi>B-FT.CE.107FH.2.24NU</basicUdiDi>
    <tradeName>REFLU SOD</tradeName>
    <deviceName>REFLU SOD</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.107FH.2.24</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:15:02.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107FH.2.12.A02F3</udiDi>
    <basicUdiDi>B-FT.CE.107FH.2.12.A02F3</basicUdiDi>
    <tradeName>REFLU SOD</tradeName>
    <deviceName>REFLU SOD</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.107FH.2.12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:14:58.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107FA.1.12KK</udiDi>
    <basicUdiDi>B-FT.CE.107FA.1.12KK</basicUdiDi>
    <tradeName>REFLUSEN PLUS 12 stick pack of 15 ml</tradeName>
    <deviceName>REFLUSEN PLUS 12 stick pack of 15 ml</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.107FA.1.12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:14:57.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FH.4.2105Y</udiDi>
    <basicUdiDi>B-FT.CE.107.FH.4.2105Y</basicUdiDi>
    <tradeName>GASTU SOD</tradeName>
    <deviceName>GASTU SOD</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.FH.4.210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:14:56.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FH.3.3005P</udiDi>
    <basicUdiDi>B-FT.CE.107.FH.3.3005P</basicUdiDi>
    <tradeName>RILEFAST SOD</tradeName>
    <deviceName>RILEFAST SOD</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.FH.3.300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:14:56.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FH.3.2105M</udiDi>
    <basicUdiDi>B-FT.CE.107.FH.3.2105M</basicUdiDi>
    <tradeName>RILEFAST SOD</tradeName>
    <deviceName>RILEFAST SOD</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.107.3.210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:14:51.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FH.2.3005C</udiDi>
    <basicUdiDi>B-FT.CE.107.FH.2.3005C</basicUdiDi>
    <tradeName>REFLUSOD</tradeName>
    <deviceName>REFLUSOD</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.FH.2.300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:14:50.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FH.2.2105A</udiDi>
    <basicUdiDi>B-FT.CE.107.FH.2.2105A</basicUdiDi>
    <tradeName>REFLUSOD</tradeName>
    <deviceName>REFLUSOD</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.FH.2.210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:14:49.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FH.1.camp8L</udiDi>
    <basicUdiDi>B-FT.CE.107.FH.1.camp8L</basicUdiDi>
    <tradeName>ALGIBABY SOD</tradeName>
    <deviceName>ALGIBABY SOD</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.FH.1.camp</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:14:49.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FH.1.3004Z</udiDi>
    <basicUdiDi>B-FT.CE.107.FH.1.3004Z</basicUdiDi>
    <tradeName>ALGIBABY SOD</tradeName>
    <deviceName>ALGIBABY SOD</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.FH.1.300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:14:44.191Z</lastUpdated>
  </row>
</eudamedExport>