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    <tradeName>UNO Wound Therapy Kit 15x20</tradeName>
    <deviceName>UNO 30-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-S1520-6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:44.319Z</lastUpdated>
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    <udiDi>00849405011637</udiDi>
    <basicUdiDi>B-00849405011637</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 10x40</tradeName>
    <deviceName>UNO 30-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-S1040-6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:43.519Z</lastUpdated>
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    <udiDi>00849405011620</udiDi>
    <basicUdiDi>B-00849405011620</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 10x30</tradeName>
    <deviceName>UNO 30-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-S1030-6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:27.470Z</lastUpdated>
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    <udiDi>00849405011613</udiDi>
    <basicUdiDi>B-00849405011613</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 10x20</tradeName>
    <deviceName>UNO 30-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-S1020-6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:26.673Z</lastUpdated>
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    <udiDi>00849405011606</udiDi>
    <basicUdiDi>B-00849405011606</basicUdiDi>
    <tradeName>00849405011606</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-S0006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:25.087Z</lastUpdated>
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    <udiDi>00849405011590</udiDi>
    <basicUdiDi>B-00849405011590</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 25x25</tradeName>
    <deviceName>UNO 15-Day Therapy Kit 25x25</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-S2525-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:22.666Z</lastUpdated>
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    <udiDi>00849405011583</udiDi>
    <basicUdiDi>B-00849405011583</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 20x25</tradeName>
    <deviceName>UNO 15-Day Therapy Kit 20x25</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-S2025-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:21.064Z</lastUpdated>
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    <udiDi>00849405011576</udiDi>
    <basicUdiDi>B-00849405011576</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 20x20</tradeName>
    <deviceName>UNO 15-Day Therapy Kit 20x20</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-S2020-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:20.271Z</lastUpdated>
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    <udiDi>00849405011569</udiDi>
    <basicUdiDi>B-00849405011569</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 15x30</tradeName>
    <deviceName>UNO 15-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-S1530-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:18.670Z</lastUpdated>
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    <udiDi>00849405011552</udiDi>
    <basicUdiDi>B-00849405011552</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 15x20</tradeName>
    <deviceName>UNO 15-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-S1520-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:16.268Z</lastUpdated>
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    <udiDi>00849405011545</udiDi>
    <basicUdiDi>B-00849405011545</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 15x15</tradeName>
    <deviceName>UNO 15-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-S1515-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:14.663Z</lastUpdated>
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    <udiDi>00849405011538</udiDi>
    <basicUdiDi>B-00849405011538</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 10x40</tradeName>
    <deviceName>UNO 15-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-S1040-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:13.872Z</lastUpdated>
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    <udiDi>00849405011521</udiDi>
    <basicUdiDi>B-00849405011521</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 10x30</tradeName>
    <deviceName>UNO 15-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-S1030-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:12.263Z</lastUpdated>
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    <udiDi>00849405011514</udiDi>
    <basicUdiDi>B-00849405011514</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 10x20</tradeName>
    <deviceName>UNO 15-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-S1020-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:09.868Z</lastUpdated>
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    <udiDi>00849405011507</udiDi>
    <basicUdiDi>B-00849405011507</basicUdiDi>
    <tradeName>00849405011507</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-S0005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:08.264Z</lastUpdated>
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    <udiDi>00849405011491</udiDi>
    <basicUdiDi>B-00849405011491</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 25x25</tradeName>
    <deviceName>UNO 7-Day Therapy Kit 25x25</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-S2525-4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:07.463Z</lastUpdated>
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    <udiDi>00849405011484</udiDi>
    <basicUdiDi>B-00849405011484</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 20x25</tradeName>
    <deviceName>UNO 7-Day Therapy Kit 20x25</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-S2025-4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:05.868Z</lastUpdated>
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    <udiDi>00849405011477</udiDi>
    <basicUdiDi>B-00849405011477</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 20x20</tradeName>
    <deviceName>UNO 7-Day Therapy Kit 20x20</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-S2020-4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:03.459Z</lastUpdated>
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    <udiDi>00849405011460</udiDi>
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    <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>
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    <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>
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