<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00609271849150</udiDi>
    <basicUdiDi>0609271849159D</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>SLO1B-ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040137</udiDi>
    <basicUdiDi>06092710401354</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>BASW3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271056114</udiDi>
    <basicUdiDi>06092710561165</basicUdiDi>
    <tradeName>SlimLine™ 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>SLO1NP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040335</udiDi>
    <basicUdiDi>0609271040335A</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>BASW3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271849259</udiDi>
    <basicUdiDi>0609271849259G</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>SLO2B-ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040144</udiDi>
    <basicUdiDi>06092710401456</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>BASW4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271056213</udiDi>
    <basicUdiDi>06092710562168</basicUdiDi>
    <tradeName>SlimLine™ 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>SLO2NP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040342</udiDi>
    <basicUdiDi>0609271040345C</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>BASW4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271849358</udiDi>
    <basicUdiDi>0609271849359K</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>SLO3B-ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040151</udiDi>
    <basicUdiDi>06092710401558</basicUdiDi>
    <tradeName>Body Armor® Stirrup Walker short</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>BASWS0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271056312</udiDi>
    <basicUdiDi>0609271056316B</basicUdiDi>
    <tradeName>SlimLine™ 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>SLO3NP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040359</udiDi>
    <basicUdiDi>0609271040355E</basicUdiDi>
    <tradeName>Body Armor® Stirrup Walker short</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>BASWS0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271849457</udiDi>
    <basicUdiDi>0609271849459N</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>SLO4B-ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040168</udiDi>
    <basicUdiDi>0609271040165A</basicUdiDi>
    <tradeName>Body Armor® Stirrup Walker short</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>BASWS1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271846111</udiDi>
    <basicUdiDi>0609271846118N</basicUdiDi>
    <tradeName>SlimLine® Pediatric</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>SLP-1N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040366</udiDi>
    <basicUdiDi>0609271040365G</basicUdiDi>
    <tradeName>Body Armor® Stirrup Walker short</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>BASWS1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271846135</udiDi>
    <basicUdiDi>0609271846138S</basicUdiDi>
    <tradeName>SlimLine® Pediatric</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>SLP-1P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040175</udiDi>
    <basicUdiDi>0609271040175C</basicUdiDi>
    <tradeName>Body Armor® Stirrup Walker short</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>BASWS2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271846210</udiDi>
    <basicUdiDi>0609271846218R</basicUdiDi>
    <tradeName>SlimLine® Pediatric</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>SLP-2N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271040373</udiDi>
    <basicUdiDi>0609271040375J</basicUdiDi>
    <tradeName>Body Armor® Stirrup Walker short</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>BASWS2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:33.366Z</lastUpdated>
  </row>
</eudamedExport>