<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-060025105W</udiDi>
    <basicUdiDi>B-060025105W</basicUdiDi>
    <tradeName>MACROCOL SANAVITA (20 sachets)</tradeName>
    <deviceName>MACROCOL SANAVITA (20 sachets)</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>GC04M2 (6,65 g + excipients)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:58:24.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>05012748605596</udiDi>
    <basicUdiDi>B-05012748605596</basicUdiDi>
    <tradeName>MOVICOL®</tradeName>
    <deviceName>MOVICOL 100 DE</deviceName>
    <manufacturerName>Norgine BV</manufacturerName>
    <manufacturerSrn>NL-MF-000009565</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>None</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:32.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>04008455033914</udiDi>
    <basicUdiDi>B-04008455033914</basicUdiDi>
    <tradeName>BULLRICH Heilerde Kapseln</tradeName>
    <deviceName>Bullrich Heilerde Kapseln</deviceName>
    <manufacturerName>delta pronatura GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020877</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>339</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:41:55.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>04008455033518</udiDi>
    <basicUdiDi>B-04008455033518</basicUdiDi>
    <tradeName>BULLRICH Heilerde Pulver ultra fein</tradeName>
    <deviceName>BULLRICH Heilerde Pulver ultra fein</deviceName>
    <manufacturerName>delta pronatura GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020877</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>335</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:41:54.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-022291M2</udiDi>
    <basicUdiDi>B-022291M2</basicUdiDi>
    <tradeName>Lucovitaal IBS</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>Artık piyasada değil</deviceStatus>
    <reference>022291</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:16:30.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-022239LY</udiDi>
    <basicUdiDi>B-022239LY</basicUdiDi>
    <tradeName>Obesimed Flat Belly</tradeName>
    <deviceName>Flat Belly</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>022239</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:16:25.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-021654M9</udiDi>
    <basicUdiDi>B-021654M9</basicUdiDi>
    <tradeName>Advancis Easyrapid Anti Di</tradeName>
    <deviceName>Anti Diarrhea</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>021654</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:11:55.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904055002888</udiDi>
    <basicUdiDi>5904055001KQ3</basicUdiDi>
    <tradeName>ULGIX WZDĘCIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000009264</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>_</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:50:10.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904055002895</udiDi>
    <basicUdiDi>5904055001KQ3</basicUdiDi>
    <tradeName>ULGIX WZDĘCIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000009264</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>_</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:50:10.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904055002901</udiDi>
    <basicUdiDi>5904055001KQ3</basicUdiDi>
    <tradeName>ULGIX WZDĘCIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000009264</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:50:10.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904055002918</udiDi>
    <basicUdiDi>5904055001KQ3</basicUdiDi>
    <tradeName>ULGIX WZDĘCIA MAX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000009264</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:50:10.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904055004226</udiDi>
    <basicUdiDi>5904055001KQ3</basicUdiDi>
    <tradeName>ULGIX USG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000009264</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:50:10.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904055004233</udiDi>
    <basicUdiDi>5904055001KQ3</basicUdiDi>
    <tradeName>ULGIX USG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000009264</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:50:10.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904055006169</udiDi>
    <basicUdiDi>5904055001KQ3</basicUdiDi>
    <tradeName>Salvit Gastricon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000009264</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:50:10.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904055006176</udiDi>
    <basicUdiDi>5904055001KQ3</basicUdiDi>
    <tradeName>Salvit Gastricon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000009264</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:50:10.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057592470577</udiDi>
    <basicUdiDi>805759247GC06EK</basicUdiDi>
    <tradeName>Liquid PEG and simethicone</tradeName>
    <deviceName>Liquid PEG and simethicone</deviceName>
    <manufacturerName>S.I.I.T. srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022188</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>GC06</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:45:20.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057592470553</udiDi>
    <basicUdiDi>805759247GC04JAK</basicUdiDi>
    <tradeName>Macrogol jars</tradeName>
    <deviceName>Macrogol jars</deviceName>
    <manufacturerName>S.I.I.T. srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022188</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>GC04D1 GC04D2 GC04E1 GC04E2 GC04E3 GC04E4 GC04F1 GC04F2 GC04I GC04L GC04P1 GC04P2 GC04P3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:45:17.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057592470546</udiDi>
    <basicUdiDi>805759247GC04SB5</basicUdiDi>
    <tradeName>Macrogol sachets</tradeName>
    <deviceName>Macrogol sachets</deviceName>
    <manufacturerName>S.I.I.T. srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022188</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>GC04A1 GC04A2 GC04B1 GC04B2 GC04C1 GC04C2 GC04M1 GC04M2 GC04G GC04N1 GC04N2 GC04N3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:45:15.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057592470539</udiDi>
    <basicUdiDi>805759247BC16DK</basicUdiDi>
    <tradeName>Kaptoflat drops and spray</tradeName>
    <deviceName>Kaptoflat drops and spray</deviceName>
    <manufacturerName>S.I.I.T. srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022188</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>BC16A and BC16B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:45:13.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034125188475</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>90COL020M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:26:46.884Z</lastUpdated>
  </row>
</eudamedExport>