<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00609271909892</udiDi>
    <basicUdiDi>0609271909899R</basicUdiDi>
    <tradeName>Peg-Assist™ Off-loading Insole</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>PW3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271889552</udiDi>
    <basicUdiDi>060927188955AM</basicUdiDi>
    <tradeName>Body Armor® Cast 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>BACS5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271909991</udiDi>
    <basicUdiDi>0609271909999U</basicUdiDi>
    <tradeName>Peg-Assist™ Off-loading Insole</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>PW4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271899964</udiDi>
    <basicUdiDi>060927189996BA</basicUdiDi>
    <tradeName>Body Armor® Night 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>BADS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271170117</udiDi>
    <basicUdiDi>0609271170115Y</basicUdiDi>
    <tradeName>Rigid-sole 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>RCM1B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271899971</udiDi>
    <basicUdiDi>060927189997BC</basicUdiDi>
    <tradeName>Toe Plate</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>BADS-P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271170216</udiDi>
    <basicUdiDi>06092711702163</basicUdiDi>
    <tradeName>Rigid-sole 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>RCM2B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271899162</udiDi>
    <basicUdiDi>060927189916AJ</basicUdiDi>
    <tradeName>Body Armor® Night 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>BADS-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271170315</udiDi>
    <basicUdiDi>06092711703166</basicUdiDi>
    <tradeName>Rigid-sole 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>RCM3B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040106</udiDi>
    <basicUdiDi>0609271040104W</basicUdiDi>
    <tradeName>Body Armor® Stirrup Walker</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>BASW0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271170414</udiDi>
    <basicUdiDi>06092711704169</basicUdiDi>
    <tradeName>Rigid-sole 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>RCM4B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040304</udiDi>
    <basicUdiDi>06092710403054</basicUdiDi>
    <tradeName>Body Armor® Stirrup Walker</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>BASW0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271173118</udiDi>
    <basicUdiDi>0609271173116F</basicUdiDi>
    <tradeName>Rigid-sole 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>RCW1B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040113</udiDi>
    <basicUdiDi>0609271040114Y</basicUdiDi>
    <tradeName>Body Armor® Stirrup Walker</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>BASW1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271173217</udiDi>
    <basicUdiDi>0609271173216J</basicUdiDi>
    <tradeName>Rigid-sole 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>RCW2B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:34.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040311</udiDi>
    <basicUdiDi>06092710403156</basicUdiDi>
    <tradeName>Body Armor® Stirrup Walker</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>BASW1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271173316</udiDi>
    <basicUdiDi>0609271173316M</basicUdiDi>
    <tradeName>Rigid-sole 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>RCW3B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040120</udiDi>
    <basicUdiDi>06092710401252</basicUdiDi>
    <tradeName>Body Armor® Stirrup Walker</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>BASW2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271849051</udiDi>
    <basicUdiDi>0609271849059A</basicUdiDi>
    <tradeName>SlimLine®</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>SLO0B-ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040328</udiDi>
    <basicUdiDi>06092710403258</basicUdiDi>
    <tradeName>Body Armor® Stirrup Walker</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>BASW2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.895Z</lastUpdated>
  </row>
</eudamedExport>