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<eudamedExport entity="devices">
  <row>
    <udiDi>05061081789524</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Women, Left, 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>KCH403</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:47:37.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789517</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Child, Right, 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>KCH402</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:45:39.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789500</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Child, Right, 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>KCH401</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:43:25.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789494</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Child, Right, 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>KCH400</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:42:22.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789487</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Child, Left, 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>KCH399</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:40:38.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789470</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Child, Left, 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>KCH398</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:38:41.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789463</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Child, Left, 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>KCH397</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:35:41.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789456</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, 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>KCHC92</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:33:59.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789449</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, 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>KCHC91</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:31:27.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789432</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, 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>KCHC90</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:29:52.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789425</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, 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>KCHC89</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:27:31.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789418</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cover, X-Large, Colour</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>KAC48</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:24:17.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789401</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cover, Large, Colour</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>KAC47</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:21:13.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789395</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cover, Medium, Colour</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>KAC46</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:17:31.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789388</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cover, Small, Colour</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>KAC45</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:16:02.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789371</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cover, X-Large, Mountain Adventure</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>KAC44</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:12:51.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789364</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cover, Large, Mountain Adventure</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>KAC43</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:07:04.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789357</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cover, Medium, Mountain Adventure</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>KAC42</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:04:25.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789340</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cover, Small, Mountain Adventure</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>KAC41</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T18:02:35.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789333</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cover, X-Large, Travelling Tracks</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>KAC40</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T17:59:30.306Z</lastUpdated>
  </row>
</eudamedExport>