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<eudamedExport entity="devices">
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    <udiDi>05704101014915</udiDi>
    <basicUdiDi>5704101BUNEWY</basicUdiDi>
    <tradeName>Bulkamid® Needle</tradeName>
    <deviceName>Bulkamid® Needle</deviceName>
    <manufacturerName>Contura International A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000002018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0780</emdnCode>
    <emdnDescription>DEVICES FOR THE TREATMENT OF INCONTINENCE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10001491</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:58:45.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>05704101500098</udiDi>
    <basicUdiDi>5704101BulkamidCG</basicUdiDi>
    <tradeName>Bulkamid® Hydrogel</tradeName>
    <deviceName>Bulkamid® Hydrogel</deviceName>
    <manufacturerName>Contura International A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000002018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070199</emdnCode>
    <emdnDescription>INTERNAL SYSTEMS FOR THE TREATMENT OF INCONTINENCE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:58:44.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060222471625</udiDi>
    <basicUdiDi>506022247VALVE4V</basicUdiDi>
    <tradeName>Ugo Catheter Valve</tradeName>
    <deviceName>Ugo Catheter Valve</deviceName>
    <manufacturerName>Optimum Medical Solutions Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000005194</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0780</emdnCode>
    <emdnDescription>DEVICES FOR THE TREATMENT OF INCONTINENCE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:34:44.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060152310711</udiDi>
    <basicUdiDi>506015231TF0009N2</basicUdiDi>
    <tradeName>GB Libra Sheath</tradeName>
    <deviceName>Sheath</deviceName>
    <manufacturerName>Clinisupplies GB Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023993</manufacturerSrn>
    <authorisedRepresentativeName>MD REPS Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000040375</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBLSS24</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:03.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>05036100005688</udiDi>
    <basicUdiDi>50361000U0017P</basicUdiDi>
    <tradeName>Prosys Flofit Self Adhesive Silicon Sheath-Std, 24mm</tradeName>
    <deviceName>UROLOGY</deviceName>
    <manufacturerName>Clinisupplies Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023783</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS24STD/B</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:57:55.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435139743</udiDi>
    <basicUdiDi>5033435K00053ZK</basicUdiDi>
    <tradeName>Perfect PFE for Men</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-MEN</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:56:44.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435136971</udiDi>
    <basicUdiDi>5033435K00030Z7</basicUdiDi>
    <tradeName>iTouch Sure 2 (ES FR DE IT)</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 (ES FR DE IT)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:56:33.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435136414</udiDi>
    <basicUdiDi>5033435K00072DSP</basicUdiDi>
    <tradeName>Sure PRO</tradeName>
    <deviceName>Sure PRO</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-SP</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:56:17.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435136285</udiDi>
    <basicUdiDi>5033435K00130DS4</basicUdiDi>
    <tradeName>Unicare</tradeName>
    <deviceName>Unicare</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-UNICARE</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:56:04.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435136278</udiDi>
    <basicUdiDi>5033435K00138DSU</basicUdiDi>
    <tradeName>Alivia</tradeName>
    <deviceName>Alivia</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-ALIVIA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:56:04.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>05033435135967</udiDi>
    <basicUdiDi>5033435K00138ZU</basicUdiDi>
    <tradeName>Alivia</tradeName>
    <deviceName>Alivia</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-ALIVIA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:55:58.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>05017950000214</udiDi>
    <basicUdiDi>5017950CliniSureSheathMJ</basicUdiDi>
    <tradeName>CliniSure Urinary Sheath Pop On 24mm</tradeName>
    <deviceName>CliniSure Urinary Sheath</deviceName>
    <manufacturerName>CliniMed Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023784</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS24P</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:51:21.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>05016189618337</udiDi>
    <basicUdiDi>5016189EMPELVIC3G</basicUdiDi>
    <tradeName>Empelvic</tradeName>
    <deviceName>Empelvic</deviceName>
    <manufacturerName>Owen Mumford Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000021000</manufacturerSrn>
    <authorisedRepresentativeName>Owen Mumford GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000020700</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-006183</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:48:36.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897043855027</udiDi>
    <basicUdiDi>489704385FGE3A0FQ</basicUdiDi>
    <tradeName>Urinalkondom</tradeName>
    <deviceName>Male External Catheter</deviceName>
    <manufacturerName>First Global Enterprises Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000022525</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3A0125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:13:08.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716820130280</udiDi>
    <basicUdiDi>471682013693410HW</basicUdiDi>
    <tradeName>Supersoft</tradeName>
    <deviceName>Silicone External Catheter</deviceName>
    <manufacturerName>Dileh Medical supplies co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000016927</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30013</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:42:16.571Z</lastUpdated>
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  <row>
    <udiDi>04716820130235</udiDi>
    <basicUdiDi>471682013693410HW</basicUdiDi>
    <tradeName>Supersoft</tradeName>
    <deviceName>Silicone External Catheter</deviceName>
    <manufacturerName>Dileh Medical supplies co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000016927</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30006</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:33:47.338Z</lastUpdated>
  </row>
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    <udiDi>04262560510023</udiDi>
    <basicUdiDi>426256HNJ-1000LQ</basicUdiDi>
    <tradeName>dres kegel</tradeName>
    <deviceName>Biofeedback System</deviceName>
    <manufacturerName>SmartMann GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000049779</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070301</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES, BIOFEEDBACK, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMM-CA0508-2K504</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:43:38.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262560510030</udiDi>
    <basicUdiDi>426256HNJ-350KPK</basicUdiDi>
    <tradeName>dres kegel</tradeName>
    <deviceName>Biofeedback System</deviceName>
    <manufacturerName>SmartMann GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000049779</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070301</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES, BIOFEEDBACK, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMM-CA0507-1K504</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:43:37.049Z</lastUpdated>
  </row>
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    <udiDi>04260217668028</udiDi>
    <basicUdiDi>426021766-T-PessariesHG</basicUdiDi>
    <tradeName>femicare Cube Pessary 25 mm</tradeName>
    <deviceName>Pessaries</deviceName>
    <manufacturerName>tic Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000033923</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>C25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:44:27.097Z</lastUpdated>
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    <udiDi>04260217666000</udiDi>
    <basicUdiDi>426021766-TA-IPQN</basicUdiDi>
    <tradeName>Vaginal probe for BASIC+/SaneoLINE devices</tradeName>
    <deviceName>Intracorporeal electrode</deviceName>
    <manufacturerName>tic Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000033923</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0780</emdnCode>
    <emdnDescription>DEVICES FOR THE TREATMENT OF INCONTINENCE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ti1026</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:44:18.343Z</lastUpdated>
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