<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00849405000556</udiDi>
    <basicUdiDi>B-00849405000556</basicUdiDi>
    <tradeName>Silver Spiro Foam Dressing</tradeName>
    <deviceName>Silver Spiro Foam Medium</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040801</emdnCode>
    <emdnDescription>SILVER DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-SPMF1-AG</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:20.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000549</udiDi>
    <basicUdiDi>B-00849405000549</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 10x10</tradeName>
    <deviceName>UNO 7-Day Therapy Kit 10x10</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U-S1010-4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:16.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000532</udiDi>
    <basicUdiDi>B-00849405000532</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 10x10</tradeName>
    <deviceName>UNO 15-Day Therapy Kit 10x10</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U-S1010-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:15.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000525</udiDi>
    <basicUdiDi>B-00849405000525</basicUdiDi>
    <tradeName>UNO 10x10 Dressing</tradeName>
    <deviceName>UNO 10x10 Dressing kit</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UNO-0404</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:14.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000518</udiDi>
    <basicUdiDi>B-00849405000518</basicUdiDi>
    <tradeName>GentilFoam Soft Silicone foam dressing 150 mm x 150 mm</tradeName>
    <deviceName>Gentilfoam 15 x 15 cm</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>420606</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:13.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000501</udiDi>
    <basicUdiDi>B-00849405000501</basicUdiDi>
    <tradeName>Silver Spiro Foam Kit Medium</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040801</emdnCode>
    <emdnDescription>SILVER DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-SPMK1-AG</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:08.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000495</udiDi>
    <basicUdiDi>B-00849405000495</basicUdiDi>
    <tradeName>UNO+ Negative Pressure Wound Therapy Device</tradeName>
    <deviceName>UNO+ NPWT Device</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP-S01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:08.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000488</udiDi>
    <basicUdiDi>B-00849405000488</basicUdiDi>
    <tradeName>UNO+ 300 CC</tradeName>
    <deviceName>UNO Plus 300 CC Collection Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP-S00D3</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:07.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000471</udiDi>
    <basicUdiDi>B-00849405000471</basicUdiDi>
    <tradeName>Silver Foam Large</tradeName>
    <deviceName>Silver Foam Large</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040801</emdnCode>
    <emdnDescription>SILVER DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-AGLFOAM2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:06.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000464</udiDi>
    <basicUdiDi>B-00849405000464</basicUdiDi>
    <tradeName>Silver Foam Medium</tradeName>
    <deviceName>Silver Foam Medium</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040801</emdnCode>
    <emdnDescription>SILVER DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-AGMFOAM2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:02.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000457</udiDi>
    <basicUdiDi>B-00849405000457</basicUdiDi>
    <tradeName>Silver Foam Small</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040801</emdnCode>
    <emdnDescription>SILVER DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-AGSFOAM2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:01.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000426</udiDi>
    <basicUdiDi>B-00849405000426</basicUdiDi>
    <tradeName>XLR8 1100 CC Canister</tradeName>
    <deviceName>XLR8 1100 cc Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4-S00D11</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:00.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000419</udiDi>
    <basicUdiDi>B-00849405000419</basicUdiDi>
    <tradeName>XLR8 800 CC Canister</tradeName>
    <deviceName>XLR8 800 cc Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4-S00D8</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:00.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000402</udiDi>
    <basicUdiDi>B-00849405000402</basicUdiDi>
    <tradeName>XLR8 600 CC Canister</tradeName>
    <deviceName>XLR8 600 cc Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4-S00D6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:55.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000396</udiDi>
    <basicUdiDi>B-00849405000396</basicUdiDi>
    <tradeName>XLR8 200 CC Canister</tradeName>
    <deviceName>XLR8 200 cc Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4-S00D2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:54.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000389</udiDi>
    <basicUdiDi>B-00849405000389</basicUdiDi>
    <tradeName>UNO+ 200 CC</tradeName>
    <deviceName>UNO Plus 200 CC Collection Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP-S00D2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:53.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000174</udiDi>
    <basicUdiDi>B-00849405000174</basicUdiDi>
    <tradeName>Nanogen Aktiv NANO-STRUCTURED MEMBRANE 10cm x 20cm</tradeName>
    <deviceName>Nanogen Aktiv 10cm x 20cm</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610408</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:52.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000167</udiDi>
    <basicUdiDi>B-00849405000167</basicUdiDi>
    <tradeName>Nanogen Aktiv NANO-STRUCTURED MEMBRANE 10cm x 10cm [EN]</tradeName>
    <deviceName>Nanogen Aktiv 10cm x 10cm</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610404</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:48.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000150</udiDi>
    <basicUdiDi>B-00849405000150</basicUdiDi>
    <tradeName>Nanogen Aktiv NANO-STRUCTURED MEMBRANE 8cm x 8cm [EN]</tradeName>
    <deviceName>Nanogen Aktiv 8cm x 8cm</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610303</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:48.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000143</udiDi>
    <basicUdiDi>B-00849405000143</basicUdiDi>
    <tradeName>Nanogen Aktiv NANO-STRUCTURED MEMBRANE 5cm x 5cm</tradeName>
    <deviceName>Nanogen Aktiv 5cm x 5cm</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610202</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:47.198Z</lastUpdated>
  </row>
</eudamedExport>