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<eudamedExport entity="devices">
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    <basicUdiDi>5690967BU00066NP</basicUdiDi>
    <tradeName>Formfit® Shoulder Brace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Össur Iceland ehf.</manufacturerName>
    <manufacturerSrn>IS-MF-000000173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSS-SO</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:21:17.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977812261513</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261513</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977812261520</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261520</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.299Z</lastUpdated>
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    <udiDi>06977812261537</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261537</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977812261544</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261544</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977812261551</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261551</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977812261568</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261568</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977812261575</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261575</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977812261582</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261582</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977812261599</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261599</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977812261605</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261605</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977812261612</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261612</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977812261629</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261629</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.114Z</lastUpdated>
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  <row>
    <udiDi>06977812261636</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261636</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.096Z</lastUpdated>
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  <row>
    <udiDi>06977812261643</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261643</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.080Z</lastUpdated>
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  <row>
    <udiDi>06977812261650</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261650</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.061Z</lastUpdated>
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  <row>
    <udiDi>06977812261667</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261667</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.042Z</lastUpdated>
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  <row>
    <udiDi>06977812261674</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261674</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.022Z</lastUpdated>
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  <row>
    <udiDi>06977812261681</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261681</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:14.003Z</lastUpdated>
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  <row>
    <udiDi>06977812261698</udiDi>
    <basicUdiDi>697781226GCSZ001XR</basicUdiDi>
    <tradeName>06977812261698</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guanchi Technology (Hebei) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044147</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060630</emdnCode>
    <emdnDescription>SHOULDER-ELBOW-WRIST- HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSZ-5019</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:50:13.987Z</lastUpdated>
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