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<eudamedExport entity="devices">
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    <udiDi>07333387047379</udiDi>
    <basicUdiDi>733338724104D3</basicUdiDi>
    <tradeName>Navina Mini Refill Set</tradeName>
    <deviceName>Navina, Bowel Management System</deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020199</emdnCode>
    <emdnDescription>GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6930930</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:37:33.513Z</lastUpdated>
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  <row>
    <udiDi>07333387032863</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric</tradeName>
    <deviceName>Single use hydrophilic urinary catheter for intermittent urinary catheterization</deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40008</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:37:32.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>07333387028118</udiDi>
    <basicUdiDi>733338724107D9</basicUdiDi>
    <tradeName>Navina Accessories</tradeName>
    <deviceName>Navina, Bowel Management System Accessories</deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6901200</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:37:31.911Z</lastUpdated>
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  <row>
    <udiDi>07333387030661</udiDi>
    <basicUdiDi>733338724102CX</basicUdiDi>
    <tradeName>LoFric Insti-Cath</tradeName>
    <deviceName>Single use hydrophilic urinary catheter for bladder instillation</deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44008</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:37:28.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>07333387027890</udiDi>
    <basicUdiDi>733338724106D7</basicUdiDi>
    <tradeName>Navina Tube Set</tradeName>
    <deviceName>Navina, Bowel Management System</deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6901100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:37:26.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>07333387027203</udiDi>
    <basicUdiDi>733338724105D5</basicUdiDi>
    <tradeName>Navina Smart System Regular</tradeName>
    <deviceName>Navina, Bowel Management System</deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6900910</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:37:25.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>07333387043319</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric Origo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44312</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:46:54.578Z</lastUpdated>
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  <row>
    <udiDi>07333387043357</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric Origo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44316</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:46:54.550Z</lastUpdated>
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  <row>
    <udiDi>07333387043395</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric Origo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44410</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:46:54.455Z</lastUpdated>
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  <row>
    <udiDi>07333387034331</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:46:54.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>07333387039442</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:46:54.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>07333387040349</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40516</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:46:54.372Z</lastUpdated>
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  <row>
    <udiDi>07333387037226</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40312</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:46:50.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>07333387033433</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:46:50.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>07333387043371</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric Origo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44318</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:48.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>07333387033730</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:46:23.104Z</lastUpdated>
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  <row>
    <udiDi>07333387043432</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric Origo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44414</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:17.389Z</lastUpdated>
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  <row>
    <udiDi>07333387034034</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:47:03.349Z</lastUpdated>
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    <udiDi>07333387040042</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40514</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:46:44.786Z</lastUpdated>
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  <row>
    <udiDi>07333387043333</udiDi>
    <basicUdiDi>733338724101CV</basicUdiDi>
    <tradeName>LoFric Origo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44314</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:46:42.750Z</lastUpdated>
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