<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05391536221966</udiDi>
    <basicUdiDi>539153622OFA-EXTEK</basicUdiDi>
    <tradeName>Ostoform  Barrier Extender</tradeName>
    <deviceName>Ostoform Barrier Extender</deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108001</emdnCode>
    <emdnDescription>RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFA-10010</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:59:24.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536221287</udiDi>
    <basicUdiDi>539153622A1-BSFMz5G</basicUdiDi>
    <tradeName>Ostoform Crest Moldable Barrier</tradeName>
    <deviceName>Ostoform Crest Moldable Barrier</deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108001</emdnCode>
    <emdnDescription>RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1-BSFMz</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:59:23.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536221164</udiDi>
    <basicUdiDi>539153622OFA-OB8C</basicUdiDi>
    <tradeName>05391536221164</tradeName>
    <deviceName>Ostoform Belt</deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108006</emdnCode>
    <emdnDescription>ABDOMINAL OSTOMY SUPPORT BELTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFA-OB-120</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:59:22.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536220563</udiDi>
    <basicUdiDi>539153622OFA-UP9S</basicUdiDi>
    <tradeName>Ostoform FLOWASSIST Urostomy Pouch</tradeName>
    <deviceName>Ostoform FLOWASSIST Urostomy Pouch</deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A10020402</emdnCode>
    <emdnDescription>UROSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFA-UP57</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:59:21.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536220532</udiDi>
    <basicUdiDi>539153622OFA-DP87</basicUdiDi>
    <tradeName>Ostoform FLOWASSIST Drainable Pouch</tradeName>
    <deviceName>Ostoform FLOWASSIST Drainable Pouch</deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A10020302</emdnCode>
    <emdnDescription>ILEOSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFA-DP57</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:59:18.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536220099</udiDi>
    <basicUdiDi>539153622OFAKP</basicUdiDi>
    <tradeName>Ostoform Moldable Seal with FLOWASSIST Protection</tradeName>
    <deviceName>FLOWASSIST Seal</deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108001</emdnCode>
    <emdnDescription>RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OFA-M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:59:18.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536221706</udiDi>
    <basicUdiDi>539153622OFA-UP9S</basicUdiDi>
    <tradeName>Ostoform FLOWASSIST Urostomy Pouch</tradeName>
    <deviceName>Ostoform FLOWASSIST Urostomy Pouch</deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A10020402</emdnCode>
    <emdnDescription>UROSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFA-UP57</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:57:57.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536222123</udiDi>
    <basicUdiDi>539153622OFA-1CBUPQN</basicUdiDi>
    <tradeName>Ostoform FLOWASSIST Convex Urostomy Pouch</tradeName>
    <deviceName>Ostoform FLOWASSIST Convex Urostomy Pouch</deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A1001030202</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR RETRACTED STOMA, CONVEX, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFA-10012-S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:20:01.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536222031</udiDi>
    <basicUdiDi>539153622OFA-1CBDPP3</basicUdiDi>
    <tradeName>Ostoform FLOWASSIST Convex Drainable Pouch</tradeName>
    <deviceName>Ostoform FLOWASSIST Convex Drainable Pouch</deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A1001020202</emdnCode>
    <emdnDescription>ONE-PIECE ILEOSTOMY BAGS FOR RETRACTED STOMA, CONVEX, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFA-10011-S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:20:00.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536220839</udiDi>
    <basicUdiDi>539153622OFA-CP84</basicUdiDi>
    <tradeName>Ostoform FLOWASSIST Closed Pouch</tradeName>
    <deviceName>Ostoform FLOWASSIST Closed Pouch</deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A10020202</emdnCode>
    <emdnDescription>COLOSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFA-CP57</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:19:56.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536221584</udiDi>
    <basicUdiDi>539153622OFA-CB78</basicUdiDi>
    <tradeName>Ostoform FLOWASSIST Convex Baseplate</tradeName>
    <deviceName>Ostoform FLOWASSIST Convex Baseplate</deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A1002010402</emdnCode>
    <emdnDescription>UNIVERSAL PLATES FOR ABDOMINAL STOMA (COLO-, ILEO-, UROSTOMY) WITH INTROFLEX STOMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFA-CB57-S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:19:55.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536220655</udiDi>
    <basicUdiDi>539153622OFA-FB7H</basicUdiDi>
    <tradeName>Ostoform FLOWASSIST Flat Baseplate</tradeName>
    <deviceName>Ostoform FLOWASSIST Flat Baseplate</deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A1002010401</emdnCode>
    <emdnDescription>UNIVERSAL PLATES FOR ABDOMINAL STOMA (COLO-, ILEO-, UROSTOMY) WITH NON-INTROFLEX STOMA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OFA-FB57-S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:19:52.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536220105</udiDi>
    <basicUdiDi>539153622OFAKP</basicUdiDi>
    <tradeName>Ostoform Moldable Seal with FLOWASSIST Protection</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A108001</emdnCode>
    <emdnDescription>RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OFA-L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T07:34:02.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536220112</udiDi>
    <basicUdiDi>539153622OFAKP</basicUdiDi>
    <tradeName>Ostoform Moldable Seal with FLOWASSIST Protection</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A108001</emdnCode>
    <emdnDescription>RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OFA-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T07:34:02.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536220136</udiDi>
    <basicUdiDi>539153622OFAKP</basicUdiDi>
    <tradeName>Ostoform Moldable Seal with FLOWASSIST Protection</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A108001</emdnCode>
    <emdnDescription>RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OFA-S-S2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T07:34:02.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536220143</udiDi>
    <basicUdiDi>539153622OFAKP</basicUdiDi>
    <tradeName>Ostoform Moldable Seal with FLOWASSIST Protection</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A108001</emdnCode>
    <emdnDescription>RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OFA-M-S2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T07:34:02.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536220150</udiDi>
    <basicUdiDi>539153622OFAKP</basicUdiDi>
    <tradeName>Ostoform Moldable Seal with FLOWASSIST Protection</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A108001</emdnCode>
    <emdnDescription>RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OFA-L-S2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T07:34:02.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536220341</udiDi>
    <basicUdiDi>539153622OFAKP</basicUdiDi>
    <tradeName>FLOWASSIST Seal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A108001</emdnCode>
    <emdnDescription>RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFA-S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T07:34:02.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536220365</udiDi>
    <basicUdiDi>539153622OFAKP</basicUdiDi>
    <tradeName>FLOWASSIST Seal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A108001</emdnCode>
    <emdnDescription>RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFA-M</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T07:34:02.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391536220389</udiDi>
    <basicUdiDi>539153622OFAKP</basicUdiDi>
    <tradeName>FLOWASSIST Seal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ostoform Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000014357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A108001</emdnCode>
    <emdnDescription>RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFA-L</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T07:34:02.075Z</lastUpdated>
  </row>
</eudamedExport>