<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00849405002550</udiDi>
    <basicUdiDi>B-00849405002550</basicUdiDi>
    <tradeName>XLR8 DUO Foam Dressing Kit Small Thin</tradeName>
    <deviceName>DUO Foam Dressing Kit Small Thin</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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-DSMF1-T-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:21.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002543</udiDi>
    <basicUdiDi>B-00849405002543</basicUdiDi>
    <tradeName>XLR8 DUO Foam Dressing Kit Medium Thin</tradeName>
    <deviceName>DUO Foam Dressing Kit Medium Thin</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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-DMDF1-T-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:20.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002536</udiDi>
    <basicUdiDi>B-00849405002536</basicUdiDi>
    <tradeName>XLR8 DUO Foam Dressing Kit Large Thin</tradeName>
    <deviceName>DUO Foam Dressing Kit Large Thin</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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-DLGF1-T-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:20.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002482</udiDi>
    <basicUdiDi>B-00849405002482</basicUdiDi>
    <tradeName>DUO Canister Set 400 cc</tradeName>
    <deviceName>DUO Canister Set 400 cc</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>A7-S00D4</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:16.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002475</udiDi>
    <basicUdiDi>B-00849405002475</basicUdiDi>
    <tradeName>DUO NPWTi Port Pad</tradeName>
    <deviceName>DUO NPWTi Port Pad</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>A070103</emdnCode>
    <emdnDescription>INFUSION TUBING ADAPTERS AND CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP-2000</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:15.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002468</udiDi>
    <basicUdiDi>B-00849405002468</basicUdiDi>
    <tradeName>DUO Instill Tubing</tradeName>
    <deviceName>DUO Instill Tubing</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>A070103</emdnCode>
    <emdnDescription>INFUSION TUBING ADAPTERS AND CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP-3000</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:14.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002451</udiDi>
    <basicUdiDi>B-00849405002451</basicUdiDi>
    <tradeName>DUO NPWT Port Pad</tradeName>
    <deviceName>DUO NPWT Port Pad</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>A070101</emdnCode>
    <emdnDescription>SUCTION TUBING ADAPTERS AND CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP-1000</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:13.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002444</udiDi>
    <basicUdiDi>B-00849405002444</basicUdiDi>
    <tradeName>XLR8 DUO Perforated Instill Foam Dressing Kit</tradeName>
    <deviceName>DUO Perforated Instill Foam 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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIF-HFLGF1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:09.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002437</udiDi>
    <basicUdiDi>B-00849405002437</basicUdiDi>
    <tradeName>XLR8 DUO Silver Foam Dressing Kit Large</tradeName>
    <deviceName>DUO Silver Foam Dressing Kit 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>AG-LFOAM2-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:08.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002420</udiDi>
    <basicUdiDi>B-00849405002420</basicUdiDi>
    <tradeName>XLR8 DUO Silver Foam Dressing Kit Medium</tradeName>
    <deviceName>DUO Silver Foam Dressing Kit 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>AG-MFOAM2-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:08.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002413</udiDi>
    <basicUdiDi>B-00849405002413</basicUdiDi>
    <tradeName>XLR8 DUO Silver Foam Dressing Kit Small</tradeName>
    <deviceName>DUO Silver Foam Dressing Kit Small</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>AG-SFOAM2-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:07.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002406</udiDi>
    <basicUdiDi>B-00849405002406</basicUdiDi>
    <tradeName>XLR8 DUO PVA Foam Dressing Kit Medium</tradeName>
    <deviceName>DUO PVA Foam Dressing Kit Medium</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>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVA-FOAM1-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:03.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002390</udiDi>
    <basicUdiDi>B-00849405002390</basicUdiDi>
    <tradeName>XLR8 DUO PVA Foam Dressing Kit Large</tradeName>
    <deviceName>DUO PVA Foam Dressing Kit Large</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>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVA-LFOAM1-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:02.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002383</udiDi>
    <basicUdiDi>B-00849405002383</basicUdiDi>
    <tradeName>XLR8 DUO PVA Foam Dressing Kit Small</tradeName>
    <deviceName>DUO PVA Foam Dressing Kit Small</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>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVA-SFOAM1-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:01.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002376</udiDi>
    <basicUdiDi>B-00849405002376</basicUdiDi>
    <tradeName>XLR8 DUO Bridge Foam Dressing Kit</tradeName>
    <deviceName>DUO Bridge Foam 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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-BKMF1-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:00.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002352</udiDi>
    <basicUdiDi>B-00849405002352</basicUdiDi>
    <tradeName>XLR8 DUO Foam Dressing Kit Extra Large Thin</tradeName>
    <deviceName>DUO Foam Dressing Kit Extra Large Thin</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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-DXLF1-T-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:56.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002345</udiDi>
    <basicUdiDi>B-00849405002345</basicUdiDi>
    <tradeName>XLR8 DUO Foam Dressing Kit Large</tradeName>
    <deviceName>DUO Foam Dressing Kit Large</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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-DLGF1-D</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:56.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002338</udiDi>
    <basicUdiDi>B-00849405002338</basicUdiDi>
    <tradeName>XLR8 DUO Foam Dressing Kit Small</tradeName>
    <deviceName>DUO Foam Dressing Kit Small</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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-DSMF1-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:55.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002321</udiDi>
    <basicUdiDi>B-00849405002321</basicUdiDi>
    <tradeName>UNO+ 100 CC</tradeName>
    <deviceName>UNO Plus 100 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-S00D1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:54.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002277</udiDi>
    <basicUdiDi>B-00849405002277</basicUdiDi>
    <tradeName>Foam Dressing Large Instill</tradeName>
    <deviceName>Instill Foam Dressing Large</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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-LFOAM1i</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:50.590Z</lastUpdated>
  </row>
</eudamedExport>