<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ITMF0000247100094AE</udiDi>
    <basicUdiDi>B-ITMF0000247100094AE</basicUdiDi>
    <tradeName>PEG BIOMA</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>2026-07-23T21:42:01.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100093AC</udiDi>
    <basicUdiDi>B-ITMF0000247100093AC</basicUdiDi>
    <tradeName>SEDAPEG4000</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>2026-07-23T21:42:00.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100092AA</udiDi>
    <basicUdiDi>B-ITMF0000247100092AA</basicUdiDi>
    <tradeName>SEDAPEG4000</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>2026-07-23T21:41:57.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100091A8</udiDi>
    <basicUdiDi>B-ITMF0000247100091A8</basicUdiDi>
    <tradeName>SANIPEG FLUID</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>2026-07-23T21:41:56.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100087AH</udiDi>
    <basicUdiDi>B-ITMF0000247100087AH</basicUdiDi>
    <tradeName>SANIPEG</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>2026-07-23T21:41:56.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100089AM</udiDi>
    <basicUdiDi>B-ITMF0000247100089AM</basicUdiDi>
    <tradeName>SANIPEG FLUID</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>2026-07-23T21:41:54.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100090A6</udiDi>
    <basicUdiDi>B-ITMF0000247100090A6</basicUdiDi>
    <tradeName>SANIPEG FLUID</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>2026-07-23T21:41:53.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100088AK</udiDi>
    <basicUdiDi>B-ITMF0000247100088AK</basicUdiDi>
    <tradeName>SANIPEG</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>2026-07-23T21:41:52.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100086AF</udiDi>
    <basicUdiDi>B-ITMF0000247100086AF</basicUdiDi>
    <tradeName>SANIPEG</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>2026-07-23T21:41:48.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100085AD</udiDi>
    <basicUdiDi>B-ITMF0000247100085AD</basicUdiDi>
    <tradeName>SANIPEG</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>2026-07-23T21:41:46.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100084AB</udiDi>
    <basicUdiDi>B-ITMF0000247100084AB</basicUdiDi>
    <tradeName>SANIPEG</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>2026-07-23T21:41:46.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100083A9</udiDi>
    <basicUdiDi>B-ITMF0000247100083A9</basicUdiDi>
    <tradeName>MAKROGOL</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>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:44.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034125188802</udiDi>
    <basicUdiDi>803412518TF106M</basicUdiDi>
    <tradeName>Colinox</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drugs Minerals and Generics Italia S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000024945</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>92COL020TRM</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:02:46.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF00002471000329Q</udiDi>
    <basicUdiDi>B-ITMF00002471000329Q</basicUdiDi>
    <tradeName>GastroBalance Reflu</tradeName>
    <deviceName>ANTIREFLUSSO</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>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:51.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF00002471000319N</udiDi>
    <basicUdiDi>B-ITMF00002471000319N</basicUdiDi>
    <tradeName>GastroBalance Reflu</tradeName>
    <deviceName>ANTIREFLUSSO</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>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:50.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT.CE.107.FF.2.R.210EG</udiDi>
    <basicUdiDi>B-FT.CE.107.FF.2.R.210EG</basicUdiDi>
    <tradeName>ALGORAL INFANT ROM</tradeName>
    <deviceName>ALGORAL INFANT ROM</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.FF.ROM.210</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:43.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>04035303150288</udiDi>
    <basicUdiDi>B-04035303150288</basicUdiDi>
    <tradeName>TOXAPREVENT MEDI PLUS ECOLINE  90 g Pulver</tradeName>
    <deviceName>TOXAPREVENT MEDI PLUS ECOLINE 90 g Pulver</deviceName>
    <manufacturerName>FROXIMUN AG</manufacturerName>
    <manufacturerSrn>DE-MF-000014501</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>11001064</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:35:28.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100080A3</udiDi>
    <basicUdiDi>B-ITMF0000247100080A3</basicUdiDi>
    <tradeName>Lafarmacia. Punto Lax Polvere. con Macrogol</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>2026-07-22T19:56:02.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100079AJ</udiDi>
    <basicUdiDi>B-ITMF0000247100079AJ</basicUdiDi>
    <tradeName>Lafarmacia. Punto Lax Liquido. con Macrogol</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>2026-07-22T19:56:01.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF0000247100076AC</udiDi>
    <basicUdiDi>B-ITMF0000247100076AC</basicUdiDi>
    <tradeName>Fybogel FibreChews</tradeName>
    <deviceName>BIEFFE FIBER</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>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:55:56.832Z</lastUpdated>
  </row>
</eudamedExport>