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    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <reference>S1002-0072</reference>
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    <lastUpdated>2026-07-07T11:08:11.776Z</lastUpdated>
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    <tradeName>Carilex</tradeName>
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    <manufacturerName>CARILEX MEDICAL, INC</manufacturerName>
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    <manufacturerName>CARILEX MEDICAL, INC</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1002-3032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:11.445Z</lastUpdated>
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    <udiDi>04719873696727</udiDi>
    <basicUdiDi>471987369S1XXXRV</basicUdiDi>
    <tradeName>Carilex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARILEX MEDICAL, INC</manufacturerName>
    <manufacturerSrn>TW-MF-000002145</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1002-3042V</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:11.418Z</lastUpdated>
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    <udiDi>04719873696734</udiDi>
    <basicUdiDi>471987369S1XXXRV</basicUdiDi>
    <tradeName>Carilex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARILEX MEDICAL, INC</manufacturerName>
    <manufacturerSrn>TW-MF-000002145</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1002-3052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:11.394Z</lastUpdated>
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    <udiDi>04719873696741</udiDi>
    <basicUdiDi>471987369S1XXXRV</basicUdiDi>
    <tradeName>Carilex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARILEX MEDICAL, INC</manufacturerName>
    <manufacturerSrn>TW-MF-000002145</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1002-3062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:11.371Z</lastUpdated>
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    <udiDi>04719873696758</udiDi>
    <basicUdiDi>471987369S1XXXRV</basicUdiDi>
    <tradeName>Carilex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARILEX MEDICAL, INC</manufacturerName>
    <manufacturerSrn>TW-MF-000002145</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1002-3072</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:11.343Z</lastUpdated>
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    <udiDi>04719873696765</udiDi>
    <basicUdiDi>471987369S1XXXRV</basicUdiDi>
    <tradeName>Carilex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARILEX MEDICAL, INC</manufacturerName>
    <manufacturerSrn>TW-MF-000002145</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1002-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:11.313Z</lastUpdated>
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    <udiDi>04719873696772</udiDi>
    <basicUdiDi>471987369S1XXXRV</basicUdiDi>
    <tradeName>Carilex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARILEX MEDICAL, INC</manufacturerName>
    <manufacturerSrn>TW-MF-000002145</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1004-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:11.292Z</lastUpdated>
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    <udiDi>04719873696789</udiDi>
    <basicUdiDi>471987369S1XXXRV</basicUdiDi>
    <tradeName>Carilex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARILEX MEDICAL, INC</manufacturerName>
    <manufacturerSrn>TW-MF-000002145</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1004-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:11.273Z</lastUpdated>
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    <udiDi>04719873696796</udiDi>
    <basicUdiDi>471987369S1XXXRV</basicUdiDi>
    <tradeName>Carilex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARILEX MEDICAL, INC</manufacturerName>
    <manufacturerSrn>TW-MF-000002145</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1004-3032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:11.257Z</lastUpdated>
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    <udiDi>00860000244312</udiDi>
    <basicUdiDi>B-00860000244312</basicUdiDi>
    <tradeName>00860000244312</tradeName>
    <deviceName>ActiGraft</deviceName>
    <manufacturerName>RedDress Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000010237</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD2002P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:44:46.812Z</lastUpdated>
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    <udiDi>00851707004118</udiDi>
    <basicUdiDi>B-00851707004118</basicUdiDi>
    <tradeName>RECELL®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AVITA Medical Americas, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000027367</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C3RL01-B:EU</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:18:47.767Z</lastUpdated>
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    <udiDi>00851707004019</udiDi>
    <basicUdiDi>B-00851707004019</basicUdiDi>
    <tradeName>RECELL®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AVITA Medical Americas, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000027367</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C3RL01:EU</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:18:46.970Z</lastUpdated>
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    <udiDi>00849405011699</udiDi>
    <basicUdiDi>B-00849405011699</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 25x25</tradeName>
    <deviceName>UNO 30-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>
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    <legislation>MDD</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U-S2525-6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:51.525Z</lastUpdated>
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    <tradeName>UNO Wound Therapy Kit 20x25</tradeName>
    <deviceName>UNO 30-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-S2025-6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:50.723Z</lastUpdated>
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    <tradeName>UNO Wound Therapy Kit 20x20</tradeName>
    <deviceName>UNO 30-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-S2020-6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:49.931Z</lastUpdated>
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    <udiDi>00849405011644</udiDi>
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    <tradeName>UNO Wound Therapy Kit 15x15</tradeName>
    <deviceName>UNO 30-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-S1515-6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:45.919Z</lastUpdated>
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  <row>
    <udiDi>00849405011668</udiDi>
    <basicUdiDi>B-00849405011668</basicUdiDi>
    <tradeName>UNO Wound Therapy Kit 15x30</tradeName>
    <deviceName>UNO 30-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-S1530-6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:42:45.121Z</lastUpdated>
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