<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05061081780705</udiDi>
    <basicUdiDi>506108178TOOLBX</basicUdiDi>
    <tradeName>Foam Firm 78x50mm, Black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC9</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:44:06.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780712</udiDi>
    <basicUdiDi>506108178TOOLBX</basicUdiDi>
    <tradeName>Foam Firm 98x50mm, Black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:44:06.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780729</udiDi>
    <basicUdiDi>506108178TOOLBX</basicUdiDi>
    <tradeName>Foam Soft 38x10mm, Orange</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC11</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:44:06.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780736</udiDi>
    <basicUdiDi>506108178TOOLBX</basicUdiDi>
    <tradeName>Foam Soft 44x10mm, Orange</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:44:06.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780743</udiDi>
    <basicUdiDi>506108178TOOLBX</basicUdiDi>
    <tradeName>Foam Soft 58x10mm, Orange</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC13</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:44:06.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780750</udiDi>
    <basicUdiDi>506108178TOOLBX</basicUdiDi>
    <tradeName>Foam Soft 78x10mm, Orange</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC14</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:44:06.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780767</udiDi>
    <basicUdiDi>506108178TOOLBX</basicUdiDi>
    <tradeName>Foam Soft 98x10mm, Orange</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC15</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:44:05.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780774</udiDi>
    <basicUdiDi>506108178TOOLBX</basicUdiDi>
    <tradeName>Foam Gel 44x10mm, Black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC16</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:44:05.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780781</udiDi>
    <basicUdiDi>506108178TOOLBX</basicUdiDi>
    <tradeName>Foam Gel 58x10mm, Black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC17</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:44:05.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780798</udiDi>
    <basicUdiDi>506108178TOOLBX</basicUdiDi>
    <tradeName>Foam Gel 78x10mm, Black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC18</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:44:05.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260750881809</udiDi>
    <basicUdiDi>426075088evolutionJV</basicUdiDi>
    <tradeName>Ve5 Ti Short Flex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vincent Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061803</emdnCode>
    <emdnDescription>PARTIAL HAND PROSTHESES (INCLUDING FINGERS PROSTHESES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ve5-T-SF*</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:42.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260750881793</udiDi>
    <basicUdiDi>426075088evolutionJV</basicUdiDi>
    <tradeName>Ve5 Ti Short</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vincent Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061803</emdnCode>
    <emdnDescription>PARTIAL HAND PROSTHESES (INCLUDING FINGERS PROSTHESES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ve5-T-S*</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:41.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260750881786</udiDi>
    <basicUdiDi>426075088evolutionJV</basicUdiDi>
    <tradeName>Ve5 Ti Basic Flex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vincent Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061803</emdnCode>
    <emdnDescription>PARTIAL HAND PROSTHESES (INCLUDING FINGERS PROSTHESES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ve5-T-BF*</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:40.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260750881779</udiDi>
    <basicUdiDi>426075088evolutionJV</basicUdiDi>
    <tradeName>Ve5 Ti Basic</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vincent Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061803</emdnCode>
    <emdnDescription>PARTIAL HAND PROSTHESES (INCLUDING FINGERS PROSTHESES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ve5-T-B*</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:38.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260750881762</udiDi>
    <basicUdiDi>426075088evolutionJV</basicUdiDi>
    <tradeName>Ve5 Al Short Flex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vincent Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061803</emdnCode>
    <emdnDescription>PARTIAL HAND PROSTHESES (INCLUDING FINGERS PROSTHESES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ve5-A-SF*</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:37.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260750881755</udiDi>
    <basicUdiDi>426075088evolutionJV</basicUdiDi>
    <tradeName>Ve5 Al Short</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vincent Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061803</emdnCode>
    <emdnDescription>PARTIAL HAND PROSTHESES (INCLUDING FINGERS PROSTHESES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ve5-A-S*</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:36.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260750881748</udiDi>
    <basicUdiDi>426075088evolutionJV</basicUdiDi>
    <tradeName>Ve5 Al Basic Flex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vincent Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061803</emdnCode>
    <emdnDescription>PARTIAL HAND PROSTHESES (INCLUDING FINGERS PROSTHESES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ve5-A-BF*</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:34.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260750881731</udiDi>
    <basicUdiDi>426075088evolutionJV</basicUdiDi>
    <tradeName>Ve5 Al Basic</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vincent Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061803</emdnCode>
    <emdnDescription>PARTIAL HAND PROSTHESES (INCLUDING FINGERS PROSTHESES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ve5-A-B*</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:33.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260750880901</udiDi>
    <basicUdiDi>426075088workWE</basicUdiDi>
    <tradeName>Vwork flex wrist schwer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vincent Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061803</emdnCode>
    <emdnDescription>PARTIAL HAND PROSTHESES (INCLUDING FINGERS PROSTHESES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:31.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260750880710</udiDi>
    <basicUdiDi>426075088partial8K</basicUdiDi>
    <tradeName>Vp4 Ti 1 thumb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vincent Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061803</emdnCode>
    <emdnDescription>PARTIAL HAND PROSTHESES (INCLUDING FINGERS PROSTHESES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Vp4-T-1T*</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:23.139Z</lastUpdated>
  </row>
</eudamedExport>