<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05061081780910</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand Child, Left, Small 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>KCH3</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T02:21:55.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780903</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand Child, Left, Small 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>KCH2</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T02:11:03.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780897</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand Child, Left, Small 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>KCH1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T01:58:20.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780538</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>Day 1 ALX Tool</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>KD15</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T01:47:17.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780521</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Janet Magnetic</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>KD14</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T01:37:39.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780514</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Adaptor Magnetic</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>KD13</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T01:25:47.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780507</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>Day 1 ALX Dock, X-Large, Black</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>KD12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T01:12:30.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780491</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>Day 1 ALX Dock, Large, Black</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>KD11</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T00:59:08.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780484</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>Day 1 ALX Dock, Medium, Black</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>KD10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T00:46:41.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780477</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>Day 1 ALX Dock, Small, Black</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>KD9</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T00:30:44.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780460</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>Day 1 ALX Blank X-Large</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>KD4</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T00:14:32.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780453</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>Day 1 ALX Blank Large</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>KD3</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T00:02:01.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780446</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>Day 1 ALX Blank Medium</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>KD2</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T23:50:12.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780439</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>Day 1 ALX Blank Small</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>KD1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T23:35:02.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780262</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Sarah Pro</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>KA27</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T23:25:05.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780255</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Nicole Pro</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>KA26</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:56:34.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780248</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Joanie Yellow</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>KA25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:50:09.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780224</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Nicole</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>KA23</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:27:42.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780217</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Kitty</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>KA22</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:13:04.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081780200</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Grace</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>KA21</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-05T18:58:41.228Z</lastUpdated>
  </row>
</eudamedExport>