<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00609271796515</udiDi>
    <basicUdiDi>0609271796519S</basicUdiDi>
    <tradeName>MedSurg Original 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>MSPED-ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271016514</udiDi>
    <basicUdiDi>0609271016515M</basicUdiDi>
    <tradeName>Medical-surgical 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>MSPN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271013117</udiDi>
    <basicUdiDi>0609271013114S</basicUdiDi>
    <tradeName>MedSurg Original</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>MSW1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271013216</udiDi>
    <basicUdiDi>0609271013214V</basicUdiDi>
    <tradeName>MedSurg Original</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>MSW2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271013315</udiDi>
    <basicUdiDi>0609271013314Y</basicUdiDi>
    <tradeName>MedSurg Original</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>MSW3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271790063</udiDi>
    <basicUdiDi>0609271790068P</basicUdiDi>
    <tradeName>Medical-surgical 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>MXW3B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271809154</udiDi>
    <basicUdiDi>0609271809158H</basicUdiDi>
    <tradeName>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>NS1B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271809659</udiDi>
    <basicUdiDi>0609271809658Y</basicUdiDi>
    <tradeName>NightSplint®</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>NS1B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271809253</udiDi>
    <basicUdiDi>0609271809258L</basicUdiDi>
    <tradeName>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>NS2B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271809758</udiDi>
    <basicUdiDi>06092718097593</basicUdiDi>
    <tradeName>NightSplint®</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>NS2B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271809352</udiDi>
    <basicUdiDi>0609271809358P</basicUdiDi>
    <tradeName>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>NS3B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271809857</udiDi>
    <basicUdiDi>06092718098596</basicUdiDi>
    <tradeName>NightSplint®</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>NS3B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271809451</udiDi>
    <basicUdiDi>0609271809458S</basicUdiDi>
    <tradeName>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>NS4B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271809956</udiDi>
    <basicUdiDi>06092718099599</basicUdiDi>
    <tradeName>NightSplint®</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>NS4B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:15.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271819054</udiDi>
    <basicUdiDi>0609271819058M</basicUdiDi>
    <tradeName>OrthoWedge™ healing 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>OQ0B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:14.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271819153</udiDi>
    <basicUdiDi>0609271819158Q</basicUdiDi>
    <tradeName>OrthoWedge™ healing 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>OQ1B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:14.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271819252</udiDi>
    <basicUdiDi>0609271819258T</basicUdiDi>
    <tradeName>OrthoWedge™ healing 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>OQ2B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:14.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271819351</udiDi>
    <basicUdiDi>0609271819358W</basicUdiDi>
    <tradeName>OrthoWedge™ healing 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>OQ3B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:14.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271819450</udiDi>
    <basicUdiDi>0609271819458Z</basicUdiDi>
    <tradeName>OrthoWedge™ healing 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>OQ4B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:14.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>00609271819757</udiDi>
    <basicUdiDi>0609271819759A</basicUdiDi>
    <tradeName>OrthoWedge 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>OW-PED</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:51:14.841Z</lastUpdated>
  </row>
</eudamedExport>