<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00609271031357</udiDi>
    <basicUdiDi>0609271031355C</basicUdiDi>
    <tradeName>GTS™ Great Toe Splint</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GTS2L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:16.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271032354</udiDi>
    <basicUdiDi>0609271032355H</basicUdiDi>
    <tradeName>GTS™ Great Toe Splint</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GTS2R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:16.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000506</udiDi>
    <basicUdiDi>0609271000504E</basicUdiDi>
    <tradeName>Health Design Low Profile Cast Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-CB-TP1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:16.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000513</udiDi>
    <basicUdiDi>0609271000514G</basicUdiDi>
    <tradeName>Health Design Low Profile Cast Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-CB-TP2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:16.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000520</udiDi>
    <basicUdiDi>0609271000524J</basicUdiDi>
    <tradeName>Health Design Low Profile Cast Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-CB-TP3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:16.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000537</udiDi>
    <basicUdiDi>0609271000534L</basicUdiDi>
    <tradeName>Health Design Low Profile Cast Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-CB-TP4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:16.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000544</udiDi>
    <basicUdiDi>0609271000544N</basicUdiDi>
    <tradeName>Health Design Low Profile Cast Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-CB-TP5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:16.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000551</udiDi>
    <basicUdiDi>0609271000554Q</basicUdiDi>
    <tradeName>Health Design Low Profile Cast Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-CB-TP6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:16.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000902</udiDi>
    <basicUdiDi>0609271000904S</basicUdiDi>
    <tradeName>Health Design Classic Post Op Shoe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-PO-CL1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:16.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000919</udiDi>
    <basicUdiDi>0609271000914U</basicUdiDi>
    <tradeName>Health Design Classic Post Op Shoe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-PO-CL2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:16.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000926</udiDi>
    <basicUdiDi>0609271000924W</basicUdiDi>
    <tradeName>Health Design Classic Post Op Shoe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-PO-CL3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:16.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000933</udiDi>
    <basicUdiDi>0609271000934Y</basicUdiDi>
    <tradeName>Health Design Classic Post Op Shoe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-PO-CL4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:16.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000940</udiDi>
    <basicUdiDi>06092710009452</basicUdiDi>
    <tradeName>Health Design Classic Post Op Shoe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-PO-CL5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:16.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000957</udiDi>
    <basicUdiDi>06092710009554</basicUdiDi>
    <tradeName>Health Design Classic Post Op Shoe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-PO-CL6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000964</udiDi>
    <basicUdiDi>06092710009656</basicUdiDi>
    <tradeName>Health Design Classic Post Op Shoe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-PO-CL7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000971</udiDi>
    <basicUdiDi>06092710009758</basicUdiDi>
    <tradeName>Health Design Classic Post Op Shoe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-PO-CL8</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271000988</udiDi>
    <basicUdiDi>0609271000985A</basicUdiDi>
    <tradeName>Health Design Classic Post Op Shoe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-PO-CL9</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271001503</udiDi>
    <basicUdiDi>0609271001504K</basicUdiDi>
    <tradeName>Health Design Soft Touch Post Op Shoe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-PO-ST1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271001510</udiDi>
    <basicUdiDi>0609271001514M</basicUdiDi>
    <tradeName>Health Design Soft Touch Post Op Shoe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-PO-ST2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271001527</udiDi>
    <basicUdiDi>0609271001524P</basicUdiDi>
    <tradeName>Health Design Soft Touch Post Op Shoe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DARCO International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016195</manufacturerSrn>
    <authorisedRepresentativeName>Darco (Europe) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-PO-ST3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.804Z</lastUpdated>
  </row>
</eudamedExport>