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<eudamedExport entity="devices">
  <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>
  </row>
  <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>00850015358746</udiDi>
    <basicUdiDi>B-00850015358746</basicUdiDi>
    <tradeName>Rigicon</tradeName>
    <deviceName>Rigicon Surgical Retractor Kit</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L06050299</emdnCode>
    <emdnDescription>NON-ENDOSCOPIC UROLOGY RETRACTORS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSRK-1000</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:11.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850299008061</udiDi>
    <basicUdiDi>B-00850299008061</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTISF-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:55.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850015358418</udiDi>
    <basicUdiDi>0850015358418S9</basicUdiDi>
    <tradeName>Rigicon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSUD-1112</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:41.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850015358425</udiDi>
    <basicUdiDi>0850015358425S6</basicUdiDi>
    <tradeName>Rigicon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSUD-1314</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:41.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850015358449</udiDi>
    <basicUdiDi>0850015358449SL</basicUdiDi>
    <tradeName>Rigicon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSUD-1012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:41.826Z</lastUpdated>
  </row>
</eudamedExport>