<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810049491253</udiDi>
    <basicUdiDi>081004949ADHESIVEFE</basicUdiDi>
    <tradeName>Skinister Medical Adhesive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Molding LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042482</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Regulatory GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000047121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108008</emdnCode>
    <emdnDescription>ADHESIVES FOR ABDOMINAL OSTOMY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA1D-INT-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:38:12.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810049491260</udiDi>
    <basicUdiDi>081004949ADHESIVEFE</basicUdiDi>
    <tradeName>Skinister Medical Adhesive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Molding LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042482</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Regulatory GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000047121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108008</emdnCode>
    <emdnDescription>ADHESIVES FOR ABDOMINAL OSTOMY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA1D-INT-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:38:12.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810049491277</udiDi>
    <basicUdiDi>081004949ADHESIVEFE</basicUdiDi>
    <tradeName>Skinister Medical Adhesive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Molding LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042482</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Regulatory GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000047121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108008</emdnCode>
    <emdnDescription>ADHESIVES FOR ABDOMINAL OSTOMY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA2S-INT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:38:12.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810049491284</udiDi>
    <basicUdiDi>081004949ADHESIVEFE</basicUdiDi>
    <tradeName>Skinister Medical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Molding LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042482</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Regulatory GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000047121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108008</emdnCode>
    <emdnDescription>ADHESIVES FOR ABDOMINAL OSTOMY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA2S-INT-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:38:12.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810049491291</udiDi>
    <basicUdiDi>081004949ADHESIVEFE</basicUdiDi>
    <tradeName>Skinister Medical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Molding LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042482</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Regulatory GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000047121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108008</emdnCode>
    <emdnDescription>ADHESIVES FOR ABDOMINAL OSTOMY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA2S-INT-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:38:12.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810049491307</udiDi>
    <basicUdiDi>081004949ADHESIVEFE</basicUdiDi>
    <tradeName>Skinister Medical Adhesive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Molding LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042482</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Regulatory GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000047121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108008</emdnCode>
    <emdnDescription>ADHESIVES FOR ABDOMINAL OSTOMY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA4S-INT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:38:12.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810049491314</udiDi>
    <basicUdiDi>081004949ADHESIVEFE</basicUdiDi>
    <tradeName>Skinister Medical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Molding LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042482</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Regulatory GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000047121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108008</emdnCode>
    <emdnDescription>ADHESIVES FOR ABDOMINAL OSTOMY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA4S-INT-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:38:12.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810049491321</udiDi>
    <basicUdiDi>081004949ADHESIVEFE</basicUdiDi>
    <tradeName>Skinister Medical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Molding LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042482</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Regulatory GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000047121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108008</emdnCode>
    <emdnDescription>ADHESIVES FOR ABDOMINAL OSTOMY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA4S-INT-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:38:12.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810049491369</udiDi>
    <basicUdiDi>081004949REMOVERJD</basicUdiDi>
    <tradeName>Skinister Medical Adhesive Remover</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Molding LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042482</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Regulatory GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000047121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108005</emdnCode>
    <emdnDescription>DEVICES FOR THE REMOVAL OF ADHESIVES FROM THE PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR4S-INT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:38:12.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810049491376</udiDi>
    <basicUdiDi>081004949REMOVERJD</basicUdiDi>
    <tradeName>Skinister Medical Adhesive Remover</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Molding LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042482</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Regulatory GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000047121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108005</emdnCode>
    <emdnDescription>DEVICES FOR THE REMOVAL OF ADHESIVES FROM THE PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR2S-INT-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:38:12.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810049491444</udiDi>
    <basicUdiDi>081004949REMOVERJD</basicUdiDi>
    <tradeName>Skinister Medical Adhesive Remover</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Molding LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042482</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Regulatory GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000047121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108005</emdnCode>
    <emdnDescription>DEVICES FOR THE REMOVAL OF ADHESIVES FROM THE PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR2S-INT-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:38:12.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810049491451</udiDi>
    <basicUdiDi>081004949REMOVERJD</basicUdiDi>
    <tradeName>Skinister Medical Adhesive Remover</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Molding LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042482</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Regulatory GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000047121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108005</emdnCode>
    <emdnDescription>DEVICES FOR THE REMOVAL OF ADHESIVES FROM THE PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR4S-INT-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:38:12.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810049491468</udiDi>
    <basicUdiDi>081004949REMOVERJD</basicUdiDi>
    <tradeName>Skinister Medical Adhesive Remover</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Molding LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042482</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Regulatory GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000047121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108005</emdnCode>
    <emdnDescription>DEVICES FOR THE REMOVAL OF ADHESIVES FROM THE PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR4S-INT-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:38:12.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>05024310970261</udiDi>
    <basicUdiDi>5024310A3T4Z</basicUdiDi>
    <tradeName>05024310970261</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Welland Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000033194</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108005</emdnCode>
    <emdnDescription>DEVICES FOR THE REMOVAL OF ADHESIVES FROM THE PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>WAD060-60-ROW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:53:28.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>05024310905195</udiDi>
    <basicUdiDi>5024310A3V55</basicUdiDi>
    <tradeName>05024310905195</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Welland Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000033194</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108005</emdnCode>
    <emdnDescription>DEVICES FOR THE REMOVAL OF ADHESIVES FROM THE PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WAB050-1-ROW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:53:28.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>05024310641000</udiDi>
    <basicUdiDi>5024310A3T4Z</basicUdiDi>
    <tradeName>05024310641000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Welland Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000033194</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108005</emdnCode>
    <emdnDescription>DEVICES FOR THE REMOVAL OF ADHESIVES FROM THE PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WAD050-50-ROW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:53:27.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>05024310992652</udiDi>
    <basicUdiDi>5024310A2R4S</basicUdiDi>
    <tradeName>05024310992652</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Welland Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000033194</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108006</emdnCode>
    <emdnDescription>ABDOMINAL OSTOMY SUPPORT BELTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XBLTS01-1-AT3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:55.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>05024310992638</udiDi>
    <basicUdiDi>5024310A2R4S</basicUdiDi>
    <tradeName>05024310992638</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Welland Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000033194</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108006</emdnCode>
    <emdnDescription>ABDOMINAL OSTOMY SUPPORT BELTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XBLTL01-1-AT3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:55.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>05024310992232</udiDi>
    <basicUdiDi>5024310A2R4S</basicUdiDi>
    <tradeName>05024310992232</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Welland Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000033194</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108006</emdnCode>
    <emdnDescription>ABDOMINAL OSTOMY SUPPORT BELTS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>XBLTS01-1-KE3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:55.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>05024310987979</udiDi>
    <basicUdiDi>5024310A2R4S</basicUdiDi>
    <tradeName>05024310987979</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Welland Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000033194</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A108006</emdnCode>
    <emdnDescription>ABDOMINAL OSTOMY SUPPORT BELTS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>XBLTS01-1-CH2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:55.670Z</lastUpdated>
  </row>
</eudamedExport>