<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FTP054_8KB</udiDi>
    <basicUdiDi>B-FTP054_8KB</basicUdiDi>
    <tradeName>Doppelherz aktiv Iritakolin BG</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>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:27:10.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP054_7K9</udiDi>
    <basicUdiDi>B-FTP054_7K9</basicUdiDi>
    <tradeName>AQUILEA QBIOTICS IBS PRO ES</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>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:26:53.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP054_6K7</udiDi>
    <basicUdiDi>B-FTP054_6K7</basicUdiDi>
    <tradeName>IBS Zero 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>2026-07-13T20:26:48.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP054_5K5</udiDi>
    <basicUdiDi>B-FTP054_5K5</basicUdiDi>
    <tradeName>Kaleidon IBS ES, PT</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>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:26:48.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP054_4K3</udiDi>
    <basicUdiDi>B-FTP054_4K3</basicUdiDi>
    <tradeName>NS Florabiotic IBS Colon irritable ES</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>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:26:47.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP054_3JZ</udiDi>
    <basicUdiDi>B-FTP054_3JZ</basicUdiDi>
    <tradeName>NORMOCOLON SRB</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>Artık piyasada değil</deviceStatus>
    <reference>FTP054</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:26:46.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP054_2JX</udiDi>
    <basicUdiDi>B-FTP054_2JX</basicUdiDi>
    <tradeName>Doppelherz med Na drażliwe jelita PL</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>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:26:42.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP054_1JV</udiDi>
    <basicUdiDi>B-FTP054_1JV</basicUdiDi>
    <tradeName>Almora PLUS Normobowell GR, UAE</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>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:26:41.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP054_138Q</udiDi>
    <basicUdiDi>B-FTP054_138Q</basicUdiDi>
    <tradeName>FARLINE COLOBALANCE IBS 30 COMPRIMIDOS ES, PT</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>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:26:40.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP054_128N</udiDi>
    <basicUdiDi>B-FTP054_128N</basicUdiDi>
    <tradeName>Stomaxil Calm ES</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>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:26:40.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP054_118L</udiDi>
    <basicUdiDi>B-FTP054_118L</basicUdiDi>
    <tradeName>Belloc côlon irritable FR, DZ</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>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:26:35.369Z</lastUpdated>
  </row>
  <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>
</eudamedExport>