<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00849405002260</udiDi>
    <basicUdiDi>B-00849405002260</basicUdiDi>
    <tradeName>Foam Dressing Medium Instill</tradeName>
    <deviceName>Foam Dressing Medium Spiro Instill</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-SPMF1i</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:49.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002253</udiDi>
    <basicUdiDi>B-00849405002253</basicUdiDi>
    <tradeName>Foam Dressing Small Instill</tradeName>
    <deviceName>Foam Dressing Small Spiro Instill</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-SPSF1i</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:48.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002222</udiDi>
    <basicUdiDi>B-00849405002222</basicUdiDi>
    <tradeName>DUO Canister Set 800 cc</tradeName>
    <deviceName>DUO Canister Set 800 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-S00D8</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:48.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002185</udiDi>
    <basicUdiDi>B-00849405002185</basicUdiDi>
    <tradeName>Hybrid Dressing 10 x 40 cm</tradeName>
    <deviceName>UNO Hybrid Dressing 10 x 40 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-D1040</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:44.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002215</udiDi>
    <basicUdiDi>B-00849405002215</basicUdiDi>
    <tradeName>DUO Canister Set 1100 cc</tradeName>
    <deviceName>DUO Canister 1100 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-S00D11</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:43.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002208</udiDi>
    <basicUdiDi>B-00849405002208</basicUdiDi>
    <tradeName>DUO Canister Set 600 cc</tradeName>
    <deviceName>DUO Canister Set 600 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-S00D6</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:42.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002178</udiDi>
    <basicUdiDi>B-00849405002178</basicUdiDi>
    <tradeName>XLR8 DUO Foam Dressing Kit Medium</tradeName>
    <deviceName>DUO 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-DMDF1-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:41.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002161</udiDi>
    <basicUdiDi>B-00849405002161</basicUdiDi>
    <tradeName>XLR8 DUO Instill Foam Dressing Kit Small</tradeName>
    <deviceName>DUO Instill 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>DIF-SPSMF1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:25.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002154</udiDi>
    <basicUdiDi>B-00849405002154</basicUdiDi>
    <tradeName>XLR8 DUO Instill Foam Dressing Kit Large</tradeName>
    <deviceName>DUO Instill 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>DIF-SPLGF1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:24.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002109</udiDi>
    <basicUdiDi>B-00849405002109</basicUdiDi>
    <tradeName>XLR8 DUO Instill Foam Dressing Kit Medium</tradeName>
    <deviceName>DUO Instill 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>DIF-SPMDF1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:23.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002062</udiDi>
    <basicUdiDi>B-00849405002062</basicUdiDi>
    <tradeName>Bridge Foam Kit Small</tradeName>
    <deviceName>XLR8 Bridge 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-BKSF1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:20.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002024</udiDi>
    <basicUdiDi>B-00849405002024</basicUdiDi>
    <tradeName>Single Use Adhesive Gel Strips</tradeName>
    <deviceName>Silicone Adhesive Strips</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>M04010203</emdnCode>
    <emdnDescription>SILICONE DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS1403</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:19.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002000</udiDi>
    <basicUdiDi>B-00849405002000</basicUdiDi>
    <tradeName>Small Bridge Dressing</tradeName>
    <deviceName>Bridge Dressing 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-BDSF1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:18.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405001997</udiDi>
    <basicUdiDi>B-00849405001997</basicUdiDi>
    <tradeName>XLR8 DUO Abdominal Dressing Kit</tradeName>
    <deviceName>DUO 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-D</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:16.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405001669</udiDi>
    <basicUdiDi>B-00849405001669</basicUdiDi>
    <tradeName>Hybrid Dressing 15 x 30 cm</tradeName>
    <deviceName>UNO Hybrid Dressing 15 x 30 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-D1530</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:14.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405001652</udiDi>
    <basicUdiDi>B-00849405001652</basicUdiDi>
    <tradeName>Hybrid Dressing 15 x 20 cm</tradeName>
    <deviceName>UNO Hybrid Dressing 15 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-D1520</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:12.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405001645</udiDi>
    <basicUdiDi>B-00849405001645</basicUdiDi>
    <tradeName>Hybrid Dressing 10x50cm</tradeName>
    <deviceName>UNO Hybrid Dressing 10 x 50 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-D1050</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:12.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405001638</udiDi>
    <basicUdiDi>B-00849405001638</basicUdiDi>
    <tradeName>Hybrid Dressing 10 x 30 cm</tradeName>
    <deviceName>UNO Hybrid Dressing 10 x 30 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-D1030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:10.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405001621</udiDi>
    <basicUdiDi>B-00849405001621</basicUdiDi>
    <tradeName>00849405001621</tradeName>
    <deviceName>Genadyne Uno</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>U-S00R6</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:08.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405001614</udiDi>
    <basicUdiDi>B-00849405001614</basicUdiDi>
    <tradeName>00849405001614</tradeName>
    <deviceName>Genadyne UNO</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>U-S00R5</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:06.488Z</lastUpdated>
  </row>
</eudamedExport>