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    <manufacturerName>Marlen Mfg. &amp; Development Co.</manufacturerName>
    <manufacturerSrn>US-MF-000055888</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>595922</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:47:48.598Z</lastUpdated>
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    <basicUdiDi>0661613UROPOUCHESLA</basicUdiDi>
    <tradeName>UltraMax</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Marlen Mfg. &amp; Development Co.</manufacturerName>
    <manufacturerSrn>US-MF-000055888</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
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    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:47:48.575Z</lastUpdated>
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    <basicUdiDi>0661613UROPOUCHESLA</basicUdiDi>
    <tradeName>UltraMax</tradeName>
    <deviceName></deviceName>
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    <manufacturerSrn>US-MF-000055888</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
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    <emdnCode>A1001030102</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:47:48.552Z</lastUpdated>
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    <udiDi>00661613004771</udiDi>
    <basicUdiDi>0661613UROPOUCHESLA</basicUdiDi>
    <tradeName>UltraMax</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Marlen Mfg. &amp; Development Co.</manufacturerName>
    <manufacturerSrn>US-MF-000055888</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A1001030102</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>595932</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:47:48.538Z</lastUpdated>
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  <row>
    <udiDi>00661613004795</udiDi>
    <basicUdiDi>0661613UROPOUCHESLA</basicUdiDi>
    <tradeName>UltraMax</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Marlen Mfg. &amp; Development Co.</manufacturerName>
    <manufacturerSrn>US-MF-000055888</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A1001030102</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>595934</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:47:48.525Z</lastUpdated>
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  <row>
    <udiDi>00661613004818</udiDi>
    <basicUdiDi>0661613UROPOUCHESLA</basicUdiDi>
    <tradeName>UltraMax</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Marlen Mfg. &amp; Development Co.</manufacturerName>
    <manufacturerSrn>US-MF-000055888</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A1001030102</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>595938</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:47:48.507Z</lastUpdated>
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  <row>
    <udiDi>00661613004832</udiDi>
    <basicUdiDi>0661613UROPOUCHESLA</basicUdiDi>
    <tradeName>UltraMax</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Marlen Mfg. &amp; Development Co.</manufacturerName>
    <manufacturerSrn>US-MF-000055888</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A1001030102</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>595944</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:47:48.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>00661613004856</udiDi>
    <basicUdiDi>0661613UROPOUCHESLA</basicUdiDi>
    <tradeName>UltraMax Gemini</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Marlen Mfg. &amp; Development Co.</manufacturerName>
    <manufacturerSrn>US-MF-000055888</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A1001030102</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:47:48.465Z</lastUpdated>
  </row>
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    <udiDi>05708932077781</udiDi>
    <basicUdiDi>57089322975689F</basicUdiDi>
    <tradeName>SenSura Mio Convex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A1001030202</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR RETRACTED STOMA, CONVEX, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>168620</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:35:17.194Z</lastUpdated>
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    <udiDi>05708932076739</udiDi>
    <basicUdiDi>57089322975689F</basicUdiDi>
    <tradeName>SenSura Mio Convex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A1001030202</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR RETRACTED STOMA, CONVEX, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>168010</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:35:16.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>05708932068994</udiDi>
    <basicUdiDi>57089322975689F</basicUdiDi>
    <tradeName>SenSura Mio Convex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A1001030202</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR RETRACTED STOMA, CONVEX, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>16805</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:35:16.328Z</lastUpdated>
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  <row>
    <udiDi>05708932120890</udiDi>
    <basicUdiDi>57089322975699H</basicUdiDi>
    <tradeName>SenSura Mio Kids</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A1001030102</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>187121</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:57:24.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>05708932120913</udiDi>
    <basicUdiDi>57089322975699H</basicUdiDi>
    <tradeName>SenSura Mio Kids</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A1001030102</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>187131</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:57:24.899Z</lastUpdated>
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  <row>
    <udiDi>05708932135641</udiDi>
    <basicUdiDi>57089322975699H</basicUdiDi>
    <tradeName>SenSura Mio Kids</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A1001030102</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18712</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:57:23.677Z</lastUpdated>
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    <udiDi>05708932135665</udiDi>
    <basicUdiDi>57089322975699H</basicUdiDi>
    <tradeName>SenSura Mio Kids</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A1001030102</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18713</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:57:23.654Z</lastUpdated>
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  <row>
    <udiDi>05708932156967</udiDi>
    <basicUdiDi>570893229758197</basicUdiDi>
    <tradeName>Assura</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A1001030102</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14212</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:57:21.904Z</lastUpdated>
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  <row>
    <udiDi>05708932156981</udiDi>
    <basicUdiDi>570893229758197</basicUdiDi>
    <tradeName>Assura</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A1001030102</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14221</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:57:21.881Z</lastUpdated>
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  <row>
    <udiDi>05708932157001</udiDi>
    <basicUdiDi>570893229758197</basicUdiDi>
    <tradeName>Assura</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A1001030102</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14222</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:57:21.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>05708932862196</udiDi>
    <basicUdiDi>57089322975689F</basicUdiDi>
    <tradeName>SenSura Mio Convex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A1001030202</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR RETRACTED STOMA, CONVEX, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>16810</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:45:41.512Z</lastUpdated>
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  <row>
    <udiDi>05708932862172</udiDi>
    <basicUdiDi>57089322975689F</basicUdiDi>
    <tradeName>SenSura Mio Convex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A1001030202</emdnCode>
    <emdnDescription>ONE-PIECE UROSTOMY BAGS FOR RETRACTED STOMA, CONVEX, WITH TISSUE COVER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>16826</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:45:40.937Z</lastUpdated>
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</eudamedExport>