<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>05061081783881</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, 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>KCH300</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:50:45.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783874</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, 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>KCH299</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:47:03.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783867</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, 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>KCH298</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:43:37.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783850</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, 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>KCH297</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:41:33.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783843</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, 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>KCH296</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:39:47.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783836</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, 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>KCH295</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:37:15.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783829</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, 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>KCH294</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:36:10.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783812</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, 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>KCH293</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:33:19.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783805</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, 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>KCH292</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:29:50.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783799</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, 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>KCH291</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:27:31.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783782</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, 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>KCH290</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:26:06.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783775</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, 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>KCH289</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:22:27.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783768</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, 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>KCH288</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:19:33.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783751</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, Medium, 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>KCH287</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:15:34.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783744</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, Small, 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>KCH286</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:13:33.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783737</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, Small, 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>KCH285</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:11:18.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783720</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, Small, 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>KCH284</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:10:04.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783713</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, Small, 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>KCH283</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:07:04.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783706</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, Small, 14</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>KCH282</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:03:22.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783690</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, Small, 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>KCH281</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T08:00:15.753Z</lastUpdated>
  </row>
</eudamedExport>