<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00849405000136</udiDi>
    <basicUdiDi>B-00849405000136</basicUdiDi>
    <tradeName>Nanogen Aktiv NANO-STRUCTURED MEMBRANE 3cm x 3cm</tradeName>
    <deviceName>Nanogen Aktiv 3cm x 3cm</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>610101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:46.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000051</udiDi>
    <basicUdiDi>B-00849405000051</basicUdiDi>
    <tradeName>XLR8 400 CC Canister</tradeName>
    <deviceName>XLR8 400 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-S00D4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:41.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000013</udiDi>
    <basicUdiDi>B-00849405000013</basicUdiDi>
    <tradeName>XLR8 Transparent Film Dressing</tradeName>
    <deviceName>XLR8 Transparent Film Dressing</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>M04010202</emdnCode>
    <emdnDescription>POLYURETHANE FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4-S00F5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:40.781Z</lastUpdated>
  </row>
</eudamedExport>