<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05906146500198</udiDi>
    <basicUdiDi>59061465FFKXXXXXF</basicUdiDi>
    <tradeName>Dallop NM</tradeName>
    <deviceName>Dallop NM, Dallop NM ULTRALIGHT</deviceName>
    <manufacturerName>TRICOMED S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002483</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB-271-TNMS-003</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:12:20.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850299008061</udiDi>
    <basicUdiDi>B-00850299008061</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Saline-Filled 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>TESTISF-S</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:34:32.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>10814932020244</udiDi>
    <basicUdiDi>08019020000000000000027KC</basicUdiDi>
    <tradeName>Urolift System</tradeName>
    <deviceName>UroLift System</deviceName>
    <manufacturerName>Neotract, Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000050907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P08030101</emdnCode>
    <emdnDescription>TRANS-PROSTATIC URETHRAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UL400-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:23:53.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121803381</udiDi>
    <basicUdiDi>B-07798121803381</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>VICTO</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080102</emdnCode>
    <emdnDescription>ARTIFICIAL URINARY SPHINCTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-VICTO-55</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:12:20.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121803374</udiDi>
    <basicUdiDi>B-07798121803374</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>VICTO</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080102</emdnCode>
    <emdnDescription>ARTIFICIAL URINARY SPHINCTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-VICTO-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:12:19.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121803367</udiDi>
    <basicUdiDi>B-07798121803367</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>VICTO</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080102</emdnCode>
    <emdnDescription>ARTIFICIAL URINARY SPHINCTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-VICTO-45</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:12:18.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121803350</udiDi>
    <basicUdiDi>B-07798121803350</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>VICTO</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080102</emdnCode>
    <emdnDescription>ARTIFICIAL URINARY SPHINCTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-VICTO-40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:12:14.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121803343</udiDi>
    <basicUdiDi>B-07798121803343</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>VICTO</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080102</emdnCode>
    <emdnDescription>ARTIFICIAL URINARY SPHINCTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-VICTO-37</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:12:13.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121800151</udiDi>
    <basicUdiDi>B-07798121800151</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>N&amp;S</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-XLARGE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:12:01.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121800144</udiDi>
    <basicUdiDi>B-07798121800144</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>N&amp;S</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-LARGE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:12:00.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121800137</udiDi>
    <basicUdiDi>B-07798121800137</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>N&amp;S</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-MEDIUM</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:59.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121800120</udiDi>
    <basicUdiDi>B-07798121800120</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>N&amp;S</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-SMALL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:59.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121800113</udiDi>
    <basicUdiDi>B-07798121800113</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>Tube</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-130VS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:55.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121800106</udiDi>
    <basicUdiDi>B-07798121800106</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>Tube</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-130</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:54.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121800090</udiDi>
    <basicUdiDi>B-07798121800090</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>Tube</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-120VS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:39.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121800083</udiDi>
    <basicUdiDi>B-07798121800083</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>Tube</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:38.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121800076</udiDi>
    <basicUdiDi>B-07798121800076</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>Tube</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:38.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121800069</udiDi>
    <basicUdiDi>B-07798121800069</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>Tube</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:36.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798121800052</udiDi>
    <basicUdiDi>B-07798121800052</basicUdiDi>
    <tradeName>Promedon</tradeName>
    <deviceName>Tube</deviceName>
    <manufacturerName>PROMEDON S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023348</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-090</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:32.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290017797038</udiDi>
    <basicUdiDi>B-07290017797038</basicUdiDi>
    <tradeName>SRS Implant</tradeName>
    <deviceName>SRS Implant</deviceName>
    <manufacturerName>Lyra Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000020804</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0899</emdnCode>
    <emdnDescription>UROGENITAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6001399</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:10:21.764Z</lastUpdated>
  </row>
</eudamedExport>