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    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Brace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410010(M/Right/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.211Z</lastUpdated>
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    <udiDi>04719964463894</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Brace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410010(L/Left/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.185Z</lastUpdated>
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    <udiDi>04719964463900</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Brace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410010(L/Right/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.160Z</lastUpdated>
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    <udiDi>04719964463917</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Brace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410010(XL/Left/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.144Z</lastUpdated>
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    <udiDi>04719964463924</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Brace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410010(XL/Right/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.129Z</lastUpdated>
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  <row>
    <udiDi>04719964463931</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Lacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410011(S/Left/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.111Z</lastUpdated>
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    <udiDi>04719964463948</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Lacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410011(S/Right/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.089Z</lastUpdated>
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    <udiDi>04719964463955</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Lacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410011(M/Left/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.073Z</lastUpdated>
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    <udiDi>04719964463962</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Lacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410011(M/Right/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.060Z</lastUpdated>
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    <udiDi>04719964463979</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Lacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410011(L/Left/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.046Z</lastUpdated>
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  <row>
    <udiDi>04719964463986</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Lacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410011(L/Right/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.033Z</lastUpdated>
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    <udiDi>04719964463993</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Lacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410011(XL/Left/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.019Z</lastUpdated>
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  <row>
    <udiDi>04719964464006</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Lacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410011(XL/Right/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.000Z</lastUpdated>
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  <row>
    <udiDi>04719964464013</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Athena Wrist Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>412003(S/UNI/Blue)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:14.981Z</lastUpdated>
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  <row>
    <udiDi>04719964464020</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Athena Wrist Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>412003(M/UNI/Blue)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:14.962Z</lastUpdated>
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    <udiDi>04719964464037</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Athena Wrist Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>412003(L/UNI/Blue)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:14.941Z</lastUpdated>
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    <udiDi>04719964464044</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Athena Wrist Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>412003(XL/UNI/Blue)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:14.919Z</lastUpdated>
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    <udiDi>04719964464051</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Uni Thumb Brace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>412104(Universal/UNI/Black)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:14.898Z</lastUpdated>
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  <row>
    <udiDi>04719964464068</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Brace Spica</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>412105(S/Left/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:14.876Z</lastUpdated>
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  <row>
    <udiDi>04719964464075</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist Brace Spica</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>412105(S/Right/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:14.856Z</lastUpdated>
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