<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00849405011460</udiDi>
    <basicUdiDi>B-00849405011460</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 15x30</tradeName>
    <deviceName>UNO 7-Day Therapy Kit 15x30</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-S1530-4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:01.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405011453</udiDi>
    <basicUdiDi>B-00849405011453</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 15x20</tradeName>
    <deviceName>UNO 7-Day Therapy Kit 15x20</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-S1520-4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:01.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405011446</udiDi>
    <basicUdiDi>B-00849405011446</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 15x15</tradeName>
    <deviceName>UNO 7-Day Therapy Kit 15x15</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-S1515-4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:59.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405011439</udiDi>
    <basicUdiDi>B-00849405011439</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 10x40</tradeName>
    <deviceName>UNO 7-Day Therapy Kit 10x40</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-S1040-4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:57.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405011422</udiDi>
    <basicUdiDi>B-00849405011422</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 10x30</tradeName>
    <deviceName>UNO 7-Day Therapy Kit 10x30</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-S1030-4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:55.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405011415</udiDi>
    <basicUdiDi>B-00849405011415</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 10x20</tradeName>
    <deviceName>UNO 7-Day Therapy Kit 10x20</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-S1020-4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:54.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405011408</udiDi>
    <basicUdiDi>B-00849405011408</basicUdiDi>
    <tradeName>00849405011408</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-S0004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:53.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405011309</udiDi>
    <basicUdiDi>B-00849405011309</basicUdiDi>
    <tradeName>00849405011309</tradeName>
    <deviceName>Genadyne XLR8+ Negative PRessure Wound Therapy System</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>A4-S0003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:50.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002581</udiDi>
    <basicUdiDi>B-00849405002581</basicUdiDi>
    <tradeName>DUO NPWT SYSTEM</tradeName>
    <deviceName>DUO 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>A7-S0001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:41.849Z</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>
  <row>
    <udiDi>00849405001607</udiDi>
    <basicUdiDi>B-00849405001607</basicUdiDi>
    <tradeName>UNO NPWT Device 7 Day</tradeName>
    <deviceName>UNO Device 7 Days</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-S00R4</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:05.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405001478</udiDi>
    <basicUdiDi>B-00849405001478</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 10x10</tradeName>
    <deviceName>UNO 30-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-S1010-6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:04.076Z</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>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>08809692501008</udiDi>
    <basicUdiDi>880969250DRINVIVOPZ</basicUdiDi>
    <tradeName>Dr. INVIVO</tradeName>
    <deviceName>Dr. INVIVO</deviceName>
    <manufacturerName>ROKIT HEALTHCARE Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009720</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4D2D100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:41.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058946660002</udiDi>
    <basicUdiDi>805894666ULCOSANNEW9C</basicUdiDi>
    <tradeName>CAMERA NORMOBARICA PER OSSIGENOTERAPIA DISTRETTUALE ULCOSAN NEW</tradeName>
    <deviceName>CAMERA NORMOBARICA PER OSSIGENOTERAPIA DISTRETTUALE ULCOSAN NEW</deviceName>
    <manufacturerName>OXYVIX S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000037793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>080</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:16:49.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649996166258</udiDi>
    <basicUdiDi>76499961662000Nebbia34</basicUdiDi>
    <tradeName>07649996166258</tradeName>
    <deviceName>AeroGuard 'Nebbia'</deviceName>
    <manufacturerName>medaxis AG</manufacturerName>
    <manufacturerSrn>CH-MF-000011487</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000.2003</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:55:38.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>07649996166159</udiDi>
    <basicUdiDi>76499961662000JellyfishTX</basicUdiDi>
    <tradeName>07649996166159</tradeName>
    <deviceName>AeroGuard ‘Jellyfish’</deviceName>
    <manufacturerName>medaxis AG</manufacturerName>
    <manufacturerSrn>CH-MF-000011487</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000.2000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:55:37.564Z</lastUpdated>
  </row>
</eudamedExport>