<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00849405024101</udiDi>
    <basicUdiDi>B-00849405024101</basicUdiDi>
    <tradeName>XLR8 Abdominal Dressing Kit</tradeName>
    <deviceName>XLR8 Abdominal 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>A4-ABDO1-K</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:43:43.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405023104</udiDi>
    <basicUdiDi>B-00849405023104</basicUdiDi>
    <tradeName>Bridge Foam Kit</tradeName>
    <deviceName>XLR8 Bridge Foam 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</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:43:28.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405021322</udiDi>
    <basicUdiDi>B-00849405021322</basicUdiDi>
    <tradeName>Spiro Foam Kit Medium</tradeName>
    <deviceName>XLR8 Spiro Foam 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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-SPMK1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:43:05.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405021315</udiDi>
    <basicUdiDi>B-00849405021315</basicUdiDi>
    <tradeName>Spiro Foam Kit Small</tradeName>
    <deviceName>XLR8 Spiro Foam 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-SPSK1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:43:04.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405021247</udiDi>
    <basicUdiDi>B-00849405021247</basicUdiDi>
    <tradeName>Foam Kit XL</tradeName>
    <deviceName>XLR8 Foam Kit Thin Extra 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-DXLF1-T</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:43:03.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405021230</udiDi>
    <basicUdiDi>B-00849405021230</basicUdiDi>
    <tradeName>Foam Kit Large</tradeName>
    <deviceName>XLR8 Foam Kit Thin 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-T</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:43:02.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405021223</udiDi>
    <basicUdiDi>B-00849405021223</basicUdiDi>
    <tradeName>Foam Kit Medium</tradeName>
    <deviceName>XLR8 Foam Kit Thin 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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-DMDF1-T</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:58.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405021216</udiDi>
    <basicUdiDi>B-00849405021216</basicUdiDi>
    <tradeName>Foam Kit Small</tradeName>
    <deviceName>XLR8 Foam Kit Thin 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-T</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:57.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405021131</udiDi>
    <basicUdiDi>B-00849405021131</basicUdiDi>
    <tradeName>Foam Kit Large</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-DLGF1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:57.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405021124</udiDi>
    <basicUdiDi>B-00849405021124</basicUdiDi>
    <tradeName>Foam Kit Medium</tradeName>
    <deviceName>XLR8 Foam 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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-DMDF1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:56.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405021117</udiDi>
    <basicUdiDi>B-00849405021117</basicUdiDi>
    <tradeName>Foam Kit Small</tradeName>
    <deviceName>XLR8 Foam 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</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:52.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002628</udiDi>
    <basicUdiDi>B-00849405002628</basicUdiDi>
    <tradeName>XLR8 DUO Bridge Foam Dressing Kit Small</tradeName>
    <deviceName>DUO Bridge 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-BKSF1-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:46.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002598</udiDi>
    <basicUdiDi>B-00849405002598</basicUdiDi>
    <tradeName>Hybrid Dressing 10 x 20 cm</tradeName>
    <deviceName>UNO Hybrid Dressing 10 x 20 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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP-D1020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:42.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002574</udiDi>
    <basicUdiDi>B-00849405002574</basicUdiDi>
    <tradeName>XLR8 DUO Spiro Foam Dressing Kit Medium</tradeName>
    <deviceName>DUO Spiro 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>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XF-SPMK1-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:26.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002567</udiDi>
    <basicUdiDi>B-00849405002567</basicUdiDi>
    <tradeName>XLR8 DUO Spiro Foam Dressing Kit Small</tradeName>
    <deviceName>DUO Spiro 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-SPSK1-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:22.602Z</lastUpdated>
  </row>
  <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>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>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>
</eudamedExport>