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<eudamedExport entity="devices">
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    <basicUdiDi>5033241CATHETERSVY</basicUdiDi>
    <tradeName>Intermittent Urethral Catheters - Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ivor Shaw Ltd trading as Pennine Healthcare</manufacturerName>
    <manufacturerSrn>GB-MF-000004160</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC-1220/SW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:38:02.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033241023182</udiDi>
    <basicUdiDi>5033241CATHETERSVY</basicUdiDi>
    <tradeName>Intermittent Urethral Catheters - Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ivor Shaw Ltd trading as Pennine Healthcare</manufacturerName>
    <manufacturerSrn>GB-MF-000004160</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC-1220/SW/1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:38:02.326Z</lastUpdated>
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  <row>
    <udiDi>05033241023236</udiDi>
    <basicUdiDi>5033241CATHETERSVY</basicUdiDi>
    <tradeName>Intermittent Urethral Catheters - Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ivor Shaw Ltd trading as Pennine Healthcare</manufacturerName>
    <manufacturerSrn>GB-MF-000004160</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC-1222/SW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:38:02.294Z</lastUpdated>
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  <row>
    <udiDi>05033241023243</udiDi>
    <basicUdiDi>5033241CATHETERSVY</basicUdiDi>
    <tradeName>Intermittent Urethral Catheters - Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ivor Shaw Ltd trading as Pennine Healthcare</manufacturerName>
    <manufacturerSrn>GB-MF-000004160</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC-1222/SW/1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:38:02.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033241023298</udiDi>
    <basicUdiDi>5033241CATHETERSVY</basicUdiDi>
    <tradeName>Intermittent Urethral Catheters - Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ivor Shaw Ltd trading as Pennine Healthcare</manufacturerName>
    <manufacturerSrn>GB-MF-000004160</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC-1224/SW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:38:02.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435070039</udiDi>
    <basicUdiDi>5033435K00030Z7</basicUdiDi>
    <tradeName>iTouch Sure</tradeName>
    <deviceName>iTouch Sure 2</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-ITS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:03.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435130825</udiDi>
    <basicUdiDi>5033435K00072ZP</basicUdiDi>
    <tradeName>Sure PRO</tradeName>
    <deviceName>Sure PRO</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>UK-PR-000039358</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-SP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435132188</udiDi>
    <basicUdiDi>5033435K00053ZK</basicUdiDi>
    <tradeName>Perfect PFE</tradeName>
    <deviceName>Perfect PFE</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-PPFE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.661Z</lastUpdated>
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  <row>
    <udiDi>05033435132362</udiDi>
    <basicUdiDi>5033435K00025ZE</basicUdiDi>
    <tradeName>05033435132362</tradeName>
    <deviceName>iTouch Sure 2</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>UK-PR-000039358</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-ITS-GO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435132768</udiDi>
    <basicUdiDi>5033435K00053ZK</basicUdiDi>
    <tradeName>Pelvi+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-PELVI</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435132966</udiDi>
    <basicUdiDi>5033435K00051ZF</basicUdiDi>
    <tradeName>Perfect PFE for men</tradeName>
    <deviceName>Perfect PFE</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>UK-PR-000039358</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-PPFE-MEN NORDIC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435133543</udiDi>
    <basicUdiDi>5033435K00053ZK</basicUdiDi>
    <tradeName>Perfect PFE (Latin)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-PPFE-LATIN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435134007</udiDi>
    <basicUdiDi>5033435K00053ZK</basicUdiDi>
    <tradeName>Perfect PFE (Nordic)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-PPFE-NORDIC</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435134014</udiDi>
    <basicUdiDi>5033435K00051ZF</basicUdiDi>
    <tradeName>Perfect PFE for men (Nordic)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>UK-PR-000039358</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-PPFE-MEN NORDIC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435134021</udiDi>
    <basicUdiDi>5033435K00053ZK</basicUdiDi>
    <tradeName>Kegel Toner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-KT</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435134274</udiDi>
    <basicUdiDi>5033435K00106ZF</basicUdiDi>
    <tradeName>Elise 2</tradeName>
    <deviceName>Elise 2</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-EL2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:01.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435135431</udiDi>
    <basicUdiDi>5033435K00030Z7</basicUdiDi>
    <tradeName>iTouch Sure 2 (Nordic)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-ITS-NORDIC</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:01.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435135646</udiDi>
    <basicUdiDi>5033435K00130ZC</basicUdiDi>
    <tradeName>Unicare</tradeName>
    <deviceName>Unicare</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>UK-PR-000039358</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-UNICARE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:01.438Z</lastUpdated>
  </row>
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    <udiDi>05708265017966</udiDi>
    <basicUdiDi>57082651021-4ZD</basicUdiDi>
    <tradeName>LiNA OperaScope Scissors</tradeName>
    <deviceName>LiNA OperaScope Scissors</deviceName>
    <manufacturerName>LiNA Medical AG</manufacturerName>
    <manufacturerSrn>CH-MF-000046832</manufacturerSrn>
    <authorisedRepresentativeName>LiNA Medical Polska Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000039364</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U090399</emdnCode>
    <emdnDescription>SINGLE-USE INSTRUMENTS FOR UROGENITAL ENDOSCOPY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-SCI-3-I</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:10:55.996Z</lastUpdated>
  </row>
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    <udiDi>05708265017843</udiDi>
    <basicUdiDi>57082651021-6ZH</basicUdiDi>
    <tradeName>LiNA OperaScope Lasso</tradeName>
    <deviceName>LiNA OperaScope Lasso</deviceName>
    <manufacturerName>LiNA Medical AG</manufacturerName>
    <manufacturerSrn>CH-MF-000046832</manufacturerSrn>
    <authorisedRepresentativeName>LiNA Medical Polska Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000039364</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U090399</emdnCode>
    <emdnDescription>SINGLE-USE INSTRUMENTS FOR UROGENITAL ENDOSCOPY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-LAS10-3-I</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:10:55.196Z</lastUpdated>
  </row>
</eudamedExport>