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<eudamedExport entity="devices">
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    <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>
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  <row>
    <udiDi>00849405001454</udiDi>
    <basicUdiDi>B-00849405001454</basicUdiDi>
    <tradeName>XLR8 Port Dressing</tradeName>
    <deviceName>XLR8 Port 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>A070101</emdnCode>
    <emdnDescription>SUCTION TUBING ADAPTERS AND CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XP-1013</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:01.679Z</lastUpdated>
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  <row>
    <udiDi>00849405001058</udiDi>
    <basicUdiDi>B-00849405001058</basicUdiDi>
    <tradeName>UNO 70cc CANISTER</tradeName>
    <deviceName>UNO 70cc 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>U-C070</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:00.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000921</udiDi>
    <basicUdiDi>B-00849405000921</basicUdiDi>
    <tradeName>GentilTac Soft Silicone Interface Layer 24cm x 27.5cm</tradeName>
    <deviceName>Gentiltac 24cm x 27.5cm</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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>440911</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:59.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000914</udiDi>
    <basicUdiDi>B-00849405000914</basicUdiDi>
    <tradeName>GentilTac Soft Silicone Interface Layer 20cm x 30cm</tradeName>
    <deviceName>Gentiltac 20cm x 30cm</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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>440812</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:57.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000907</udiDi>
    <basicUdiDi>B-00849405000907</basicUdiDi>
    <tradeName>GentilTac Soft Silicone Interface Layer 17cm x 25cm</tradeName>
    <deviceName>Gentiltac 17cm x 25cm</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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>440610</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:55.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000891</udiDi>
    <basicUdiDi>B-00849405000891</basicUdiDi>
    <tradeName>GentilTac Soft Silicone Interface Layer 10cm x 18cm</tradeName>
    <deviceName>Gentiltac 10cm x 18cm</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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>440407</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:52.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000884</udiDi>
    <basicUdiDi>B-00849405000884</basicUdiDi>
    <tradeName>GentilTac Soft Silicone Interface Layer 7.5cm x 10cm</tradeName>
    <deviceName>Gentiltac 7.5cm x 10cm</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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>440304</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:52.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000877</udiDi>
    <basicUdiDi>B-00849405000877</basicUdiDi>
    <tradeName>GentilTac Soft Silicone Interface Layer 5cm x 7.5cm</tradeName>
    <deviceName>Gentiltac 5cm x 7.5cm</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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>440203</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:50.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000815</udiDi>
    <basicUdiDi>B-00849405000815</basicUdiDi>
    <tradeName>GentilFoam Border Soft Silicone foam with an adhesive border 150 mm x 200 mm</tradeName>
    <deviceName>Gentilfoam Border 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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>430608</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:48.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000808</udiDi>
    <basicUdiDi>B-00849405000808</basicUdiDi>
    <tradeName>GentilFoam Border Soft Silicone foam with an adhesive border 150 mm x 150 mm</tradeName>
    <deviceName>Gentilfoam Border 15 x 15 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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>430606</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:46.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000792</udiDi>
    <basicUdiDi>B-00849405000792</basicUdiDi>
    <tradeName>GentilFoam Border Soft Silicone foam with an adhesive border 125 mm x 125 mm</tradeName>
    <deviceName>Gentilfoam Border 12.5 x 12.5 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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>430505</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:45.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000785</udiDi>
    <basicUdiDi>B-00849405000785</basicUdiDi>
    <tradeName>GentilFoam Border Soft Silicone foam with an adhesive border 75 mm x 75 mm</tradeName>
    <deviceName>Gentilfoam Border 7.5 x 7.5 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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>430303</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:44.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000754</udiDi>
    <basicUdiDi>B-00849405000754</basicUdiDi>
    <tradeName>GentilFoam Soft Silicone foam dressing</tradeName>
    <deviceName>Gentilfoam 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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>420608</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:41.669Z</lastUpdated>
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  <row>
    <udiDi>00849405000778</udiDi>
    <basicUdiDi>B-00849405000778</basicUdiDi>
    <tradeName>GentilFoam Border Soft Silicone foam with an adhesive border 100 mm x 100 mm</tradeName>
    <deviceName>Gentilfoam Border 10 x 10 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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>430404</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:40.154Z</lastUpdated>
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  <row>
    <udiDi>00849405000761</udiDi>
    <basicUdiDi>B-00849405000761</basicUdiDi>
    <tradeName>GentilFoam Soft Silicone foam dressing 100 mm x 100 mm Contoured</tradeName>
    <deviceName>Gentilfoam Contoured 10 x 10 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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>420C44</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:38.590Z</lastUpdated>
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  <row>
    <udiDi>00849405000747</udiDi>
    <basicUdiDi>B-00849405000747</basicUdiDi>
    <tradeName>GentilFoam Soft Silicone foam dressing 100 mm x 100 mm</tradeName>
    <deviceName>Gentilfoam 10 x 10 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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>420404</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:22.419Z</lastUpdated>
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  <row>
    <udiDi>00849405000730</udiDi>
    <basicUdiDi>B-00849405000730</basicUdiDi>
    <tradeName>GentilFoam Soft Silicone foam dressing 75 mm x 75 mm</tradeName>
    <deviceName>Gentilfoam 7.5 x 7.5 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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>420303</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:21.622Z</lastUpdated>
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  <row>
    <udiDi>00849405000723</udiDi>
    <basicUdiDi>B-00849405000723</basicUdiDi>
    <tradeName>GentilFoam Soft Silicone foam dressing 50 mm x 50 mm</tradeName>
    <deviceName>Gentilfoam 5 x 5 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>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>420202</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:20.815Z</lastUpdated>
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</eudamedExport>