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<eudamedExport entity="devices">
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    <udiDi>05944732019112</udiDi>
    <basicUdiDi>5944732DEFOAMINGEQ</basicUdiDi>
    <tradeName>05944732019112</tradeName>
    <deviceName>Assista Simeticona Baby, emulsie</deviceName>
    <manufacturerName>Fiterman Pharma SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001410</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>ASSB em50</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:16:32.661Z</lastUpdated>
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  <row>
    <udiDi>05907996864416</udiDi>
    <basicUdiDi>59079968G02060399EV</basicUdiDi>
    <tradeName>ENEMA BAG, non-sterile</tradeName>
    <deviceName>non-sterile enema bags</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLN</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:35:37.318Z</lastUpdated>
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  <row>
    <udiDi>05907438941101</udiDi>
    <basicUdiDi>59074389103US</basicUdiDi>
    <tradeName>Gruszka SANITY z kanką nr 11</tradeName>
    <deviceName>Gruszka Sanity z kanką</deviceName>
    <manufacturerName>Albert Polska Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000007130</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4111200070000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:22:02.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904055005179</udiDi>
    <basicUdiDi>5904055002ZSEP</basicUdiDi>
    <tradeName>Ulgix Wzdęcia Baby</tradeName>
    <deviceName>Emulsja doustna z symetykonem ze strzykawką dozującą</deviceName>
    <manufacturerName>Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.</manufacturerName>
    <manufacturerSrn>PL-PR-000009265</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>Not applicable</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:24:20.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904055002871</udiDi>
    <basicUdiDi>5904055001KQ3</basicUdiDi>
    <tradeName>ULGIX WZDĘCIA MAX</tradeName>
    <deviceName>Kapsułki miękkie z symetykonem (Soft capsules with simethicone)</deviceName>
    <manufacturerName>Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000009264</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</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>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:24:15.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906071004334</udiDi>
    <basicUdiDi>590280270026AT</basicUdiDi>
    <tradeName>Calominal</tradeName>
    <deviceName>Calominal</deviceName>
    <manufacturerName>Aflofarm Farmacja Polska Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000001809</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0402</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR APPETITE CONTROL AND REDUCTION OF INTESTINAL ABSORPTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:10:56.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425029280014</udiDi>
    <basicUdiDi>542502928EMN19N</basicUdiDi>
    <tradeName>endomina v2</tradeName>
    <deviceName>endomina v2</deviceName>
    <manufacturerName>Endo Tools Therapeutics S.A</manufacturerName>
    <manufacturerSrn>BE-MF-000004186</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G030699</emdnCode>
    <emdnDescription>DEVICES FOR THE NON-SURGICAL TREATMENT OF OBESITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IA-EM8616610505</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:37.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025630752</udiDi>
    <basicUdiDi>542502563-NNH001-WW</basicUdiDi>
    <tradeName>05425025630752</tradeName>
    <deviceName>Slotted anoscope with LED light</deviceName>
    <manufacturerName>F Care Systems</manufacturerName>
    <manufacturerSrn>BE-MF-000000037</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G02060301</emdnCode>
    <emdnDescription>ANOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05ANOL</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:31.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025630141</udiDi>
    <basicUdiDi>542502563-ASH001-S2</basicUdiDi>
    <tradeName>HPR45i</tradeName>
    <deviceName></deviceName>
    <manufacturerName>F Care Systems</manufacturerName>
    <manufacturerSrn>BE-MF-000000037</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPR45i</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:24.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420051307234</udiDi>
    <basicUdiDi>54200513-TF21-NFL-SU-DJ</basicUdiDi>
    <tradeName>Inflation Devices</tradeName>
    <deviceName>Inflation Devices</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0380</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFL20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:01:58.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420051306732</udiDi>
    <basicUdiDi>54200513-TF23-PPT-SU-NU</basicUdiDi>
    <tradeName>Polyp Trap</tradeName>
    <deviceName>Polyp Trap</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G030399</emdnCode>
    <emdnDescription>POLYPECTOMY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF4905</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:01:56.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420051306084</udiDi>
    <basicUdiDi>54200513-TF19-CLB-SU-BJ</basicUdiDi>
    <tradeName>Cleaning Brush</tradeName>
    <deviceName>Cleaning Brush</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03080399</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF4120</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:01:54.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420051303373</udiDi>
    <basicUdiDi>54200513-TF22-EVL-SU-FY</basicUdiDi>
    <tradeName>Endoscope Valves Set</tradeName>
    <deviceName>Endoscope Valves Set</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0380</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U7000-P</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:01:53.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420051302833</udiDi>
    <basicUdiDi>54200513-TF13-XTB-SU-MM</basicUdiDi>
    <tradeName>Sterile Stone Extraction Balloon Catheter</tradeName>
    <deviceName>Sterile Stone Extraction Balloon Catheter</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03050101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, RETRIEVAL BALLOON DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF135716T</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:01:52.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420051302581</udiDi>
    <basicUdiDi>54200513-TF07-BKT-SU-EF</basicUdiDi>
    <tradeName>Sterile Extraction Basket</tradeName>
    <deviceName>Sterile Extraction Basket</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0305010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, RETRIEVAL BASKET DEVICES, REVOLVING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF1614</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:01:49.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420051302482</udiDi>
    <basicUdiDi>54200513-TF18-BBL-SU-9N</basicUdiDi>
    <tradeName>Bite Block</tradeName>
    <deviceName>Bite Block</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G030804</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U600006</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:01:47.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420051302444</udiDi>
    <basicUdiDi>54200513-TF05-MBL-SU-CF</basicUdiDi>
    <tradeName>Multiband Ligator</tradeName>
    <deviceName>Multiband Ligator</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020301</emdnCode>
    <emdnDescription>LIGATURE SYSTEMS, OESOPHAGEAL VARICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-OVL501</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:01:46.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420051301966</udiDi>
    <basicUdiDi>54200513-TF04-FBR-SU-A3</basicUdiDi>
    <tradeName>Sterile Disposable Endoscopic Forceps &amp; Retrievers</tradeName>
    <deviceName>Sterile Disposable Endoscopic Forceps &amp; Retrievers</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03050199</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U622-165</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:01:45.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420051301621</udiDi>
    <basicUdiDi>54200513-TF14-BBF-SU-4Q</basicUdiDi>
    <tradeName>Sterile Disposable Biopsy Forceps</tradeName>
    <deviceName>Sterile Disposable Biopsy Forceps</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0308010101</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, COLD BIOPSY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U160SC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:01:42.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420051301409</udiDi>
    <basicUdiDi>54200513-TF07-SPL-RU-NL</basicUdiDi>
    <tradeName>Lithotripsy System</tradeName>
    <deviceName>Lithotripsy System</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G030502</emdnCode>
    <emdnDescription>LITHOTRIPSY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF641</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:01:41.130Z</lastUpdated>
  </row>
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