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<eudamedExport entity="devices">
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    <udiDi>00850033207644</udiDi>
    <basicUdiDi>B-00850033207644</basicUdiDi>
    <tradeName>RigiSoft™</tradeName>
    <deviceName>RigiSoft™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGS1012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:07.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850033207637</udiDi>
    <basicUdiDi>B-00850033207637</basicUdiDi>
    <tradeName>RigiSoft™</tradeName>
    <deviceName>RigiSoft™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGS1013</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:06.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850033207620</udiDi>
    <basicUdiDi>B-00850033207620</basicUdiDi>
    <tradeName>RigiSoft™</tradeName>
    <deviceName>RigiSoft™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGS1014</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:02.357Z</lastUpdated>
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  <row>
    <udiDi>00850015358791</udiDi>
    <basicUdiDi>B-00850015358791</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Saline Testicular Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTIS-XL</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:18.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850015358784</udiDi>
    <basicUdiDi>B-00850015358784</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Saline Testicular Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTIS-L</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:14.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850015358760</udiDi>
    <basicUdiDi>B-00850015358760</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Saline Testicular Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTIS-M</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:13.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850015358753</udiDi>
    <basicUdiDi>B-00850015358753</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Saline Testicular Prosthesis;</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTIS-XS</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:12.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606401109030</udiDi>
    <basicUdiDi>B-00606401109030</basicUdiDi>
    <tradeName>Nagor Limited</tradeName>
    <deviceName>TFI LSR Filled Testicular Implant</deviceName>
    <manufacturerName>Nagor Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000019179</manufacturerSrn>
    <authorisedRepresentativeName>GC Aesthetics (Management) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004118</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFI-3</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:51:06.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606401109023</udiDi>
    <basicUdiDi>B-00606401109023</basicUdiDi>
    <tradeName>Nagor Limited</tradeName>
    <deviceName>TFI LSR Filled Testicular Implant</deviceName>
    <manufacturerName>Nagor Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000019179</manufacturerSrn>
    <authorisedRepresentativeName>GC Aesthetics (Management) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004118</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFI-2</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:51:05.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606401109016</udiDi>
    <basicUdiDi>B-00606401109016</basicUdiDi>
    <tradeName>Nagor Limited</tradeName>
    <deviceName>TFI LSR Filled Testicular Implant</deviceName>
    <manufacturerName>Nagor Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000019179</manufacturerSrn>
    <authorisedRepresentativeName>GC Aesthetics (Management) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004118</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFI-1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:51:03.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606401108033</udiDi>
    <basicUdiDi>B-00606401108033</basicUdiDi>
    <tradeName>Nagor Limited</tradeName>
    <deviceName>TGI-D Gel Filled Testicular Implant</deviceName>
    <manufacturerName>Nagor Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000019179</manufacturerSrn>
    <authorisedRepresentativeName>GC Aesthetics (Management) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004118</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TGID-3</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:51:01.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606401108026</udiDi>
    <basicUdiDi>B-00606401108026</basicUdiDi>
    <tradeName>Nagor Limited</tradeName>
    <deviceName>TGI-D Gel Filled Testicular Implant</deviceName>
    <manufacturerName>Nagor Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000019179</manufacturerSrn>
    <authorisedRepresentativeName>GC Aesthetics (Management) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004118</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TGID-2</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:59.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606401108019</udiDi>
    <basicUdiDi>B-00606401108019</basicUdiDi>
    <tradeName>Nagor Limited</tradeName>
    <deviceName>TGI-D Gel Filled Testicular Implant</deviceName>
    <manufacturerName>Nagor Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000019179</manufacturerSrn>
    <authorisedRepresentativeName>GC Aesthetics (Management) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004118</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TGID-1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:58.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964003967185</udiDi>
    <basicUdiDi>8964003967Ves-342H2</basicUdiDi>
    <tradeName>POWER X Vacuum Erection System</tradeName>
    <deviceName>POWER X Vacuum Erection System</deviceName>
    <manufacturerName>VES-VACUUM INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000040378</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ves-342</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:16:19.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964003967178</udiDi>
    <basicUdiDi>8964003967Ves-1314UJ</basicUdiDi>
    <tradeName>ACTIV Vacuum Erection System</tradeName>
    <deviceName>ACTIV Vacuum Erection System</deviceName>
    <manufacturerName>VES-VACUUM INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000040378</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ves-1314</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:16:16.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964003967161</udiDi>
    <basicUdiDi>8964003967Ves-1701UV</basicUdiDi>
    <tradeName>MedErect Vacuum Erection System</tradeName>
    <deviceName>MedErect Vacuum Erection System</deviceName>
    <manufacturerName>VES-VACUUM INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000040378</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ves-1701</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:16:15.641Z</lastUpdated>
  </row>
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    <udiDi>08964003967109</udiDi>
    <basicUdiDi>8964003967Ves-1361UT</basicUdiDi>
    <tradeName>UNIQ Vacuum Erection Device</tradeName>
    <deviceName>UNIQ Vacuum Erection Device</deviceName>
    <manufacturerName>VES-VACUUM INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000040378</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ves-1361</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:16:08.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964003967086</udiDi>
    <basicUdiDi>8964003967Ves-315GX</basicUdiDi>
    <tradeName>Pro-Active Plus Erection System</tradeName>
    <deviceName>Pro-Active Plus Erection System</deviceName>
    <manufacturerName>VES-VACUUM INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000040378</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ves-315</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:16:04.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964003967093</udiDi>
    <basicUdiDi>8964003967Ves-005GD</basicUdiDi>
    <tradeName>CLASSIC Vacuum Erection System</tradeName>
    <deviceName>CLASSIC Vacuum Erection System</deviceName>
    <manufacturerName>VES-VACUUM INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000040378</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ves-005</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:16:03.610Z</lastUpdated>
  </row>
</eudamedExport>