<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ITMF00002471000149N</udiDi>
    <basicUdiDi>B-ITMF00002471000149N</basicUdiDi>
    <tradeName>KEBENE ANTIACID</tradeName>
    <deviceName>ACID 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>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:03:05.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF00002471000119G</udiDi>
    <basicUdiDi>B-ITMF00002471000119G</basicUdiDi>
    <tradeName>ZENTIVA ACIDITÀ E REFLUSSO</tradeName>
    <deviceName>ACID 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>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:02:51.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF00002471000049K</udiDi>
    <basicUdiDi>B-ITMF00002471000049K</basicUdiDi>
    <tradeName>ESOXX ONE</tradeName>
    <deviceName>ESOXX ONE</deviceName>
    <manufacturerName>Biofarma S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000024710</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</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>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:02:49.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF00002471000039H</udiDi>
    <basicUdiDi>B-ITMF00002471000039H</basicUdiDi>
    <tradeName>ESOXX ONE</tradeName>
    <deviceName>ESOXX ONE</deviceName>
    <manufacturerName>Biofarma S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000024710</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</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>2026-07-13T23:02:47.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF00002471000029F</udiDi>
    <basicUdiDi>B-ITMF00002471000029F</basicUdiDi>
    <tradeName>ESOXX ONE</tradeName>
    <deviceName>ESOXX ONE</deviceName>
    <manufacturerName>Biofarma S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000024710</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</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>2026-07-13T23:02:46.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GXMEDSSP48</udiDi>
    <basicUdiDi>B-GXMEDSSP48</basicUdiDi>
    <tradeName>GASTIMAX MED (oral suspension)</tradeName>
    <deviceName>GASTIMAX MED (oral suspension)</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>GXMEDSSP</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:43:51.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GXMED52</udiDi>
    <basicUdiDi>B-GXMED52</basicUdiDi>
    <tradeName>GASTIMAX MED (chewable tablets)</tradeName>
    <deviceName>GASTIMAX 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>GXMED</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:43:51.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP091_6KL</udiDi>
    <basicUdiDi>B-FTP091_6KL</basicUdiDi>
    <tradeName>Pascosan® Reizdarm IBS-3 30 cpr DE</tradeName>
    <deviceName>SMILEUM</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>FTP091</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:29:23.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP091_5KJ</udiDi>
    <basicUdiDi>B-FTP091_5KJ</basicUdiDi>
    <tradeName>Mivolis Anti-Reizdarm 30 cpr DE, RO</tradeName>
    <deviceName>SMILEUM</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>FTP091</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:29:22.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP091_4KG</udiDi>
    <basicUdiDi>B-FTP091_4KG</basicUdiDi>
    <tradeName>Laevolac colon irritable 30 cpr IT</tradeName>
    <deviceName>SMILEUM</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>FTP091</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:29:20.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP091_3KE</udiDi>
    <basicUdiDi>B-FTP091_3KE</basicUdiDi>
    <tradeName>Imutis IBS 4 cpr BE</tradeName>
    <deviceName>SMILEUM</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>FTP091</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:29:18.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP091_2KC</udiDi>
    <basicUdiDi>B-FTP091_2KC</basicUdiDi>
    <tradeName>Imutis IBS 30 cpr BE</tradeName>
    <deviceName>SMILEUM</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>FTP091</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:29:16.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP091_1KA</udiDi>
    <basicUdiDi>B-FTP091_1KA</basicUdiDi>
    <tradeName>AQUILEA QBIOTICS COLON IRRITABLE PRO 30 cpr ES</tradeName>
    <deviceName>SMILEUM</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>FTP091</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:29:15.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP091F2</udiDi>
    <basicUdiDi>B-FTP091F2</basicUdiDi>
    <tradeName>Kaleidon IBS 60 cpr GR</tradeName>
    <deviceName>SMILEUM</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>FTP091</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:29:14.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP078_5L7</udiDi>
    <basicUdiDi>B-FTP078_5L7</basicUdiDi>
    <tradeName>FARLINE REFLUNACID  20 sticks x 10ml ES, PT</tradeName>
    <deviceName>VEGAGERD</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>FTP078</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:27:44.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP078_4L5</udiDi>
    <basicUdiDi>B-FTP078_4L5</basicUdiDi>
    <tradeName>Stomaxil Reflujo y Acidez  IT</tradeName>
    <deviceName>VEGAGERD</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>FTP078</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:27:42.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP078_3L3</udiDi>
    <basicUdiDi>B-FTP078_3L3</basicUdiDi>
    <tradeName>Acidità e reflusso. IT</tradeName>
    <deviceName>VEGAGERD</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>FTP078</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:27:40.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP078_2KZ</udiDi>
    <basicUdiDi>B-FTP078_2KZ</basicUdiDi>
    <tradeName>BIOMAGERD IT</tradeName>
    <deviceName>VEGAGERD</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>FTP078</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:27:39.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP078_1KX</udiDi>
    <basicUdiDi>B-FTP078_1KX</basicUdiDi>
    <tradeName>Almora PLUS REFLUX REPAIR GR, UAE</tradeName>
    <deviceName>VEGAGERD</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>FTP078</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:27:37.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FTP078FA</udiDi>
    <basicUdiDi>B-FTP078FA</basicUdiDi>
    <tradeName>GASTRAL REFLUX SRB</tradeName>
    <deviceName>VEGAGERD</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>FTP078</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:27:35.816Z</lastUpdated>
  </row>
</eudamedExport>