<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05061081786127</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Large, c1</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC45</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:46:10.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081786110</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 18</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC44</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:42:57.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081786103</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 17</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC43</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:40:16.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081786097</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 16</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC42</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:37:01.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081786080</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 15</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC41</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:33:44.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081786066</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 13</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC39</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:31:11.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081786042</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 11</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC37</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:28:00.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081786035</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 10</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC36</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:25:18.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081786028</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 9</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC35</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:23:44.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081786011</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 8</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC34</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:21:34.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081786004</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 7</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC33</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:19:52.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081785991</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 6</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC32</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:17:41.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081785984</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 5</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC31</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:13:49.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081785977</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 4</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC30</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:11:32.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081785960</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 3</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC29</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:08:55.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081785953</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 2</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC28</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:04:07.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081785946</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 1</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC27</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T15:00:14.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081785939</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, c4</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC26</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T14:57:27.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081785922</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, c3</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T14:56:32.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081785915</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, c2</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</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>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T14:49:17.882Z</lastUpdated>
  </row>
</eudamedExport>