<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04262429650044</udiDi>
    <basicUdiDi>426242965P01BALL2W</basicUdiDi>
    <tradeName>Explorer Ball Module, Small, without Spacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>macu4 GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038447</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4262429650044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:05:51.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262429650051</udiDi>
    <basicUdiDi>426242965P01BALL2W</basicUdiDi>
    <tradeName>Explorer Ball Module, Small, with Spacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>macu4 GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038447</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4262429650051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:05:51.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262429650075</udiDi>
    <basicUdiDi>426242965P01TWINA5</basicUdiDi>
    <tradeName>Explorer Twin Module, Standard, with Spacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>macu4 GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038447</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4262429650075</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:05:51.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262429650082</udiDi>
    <basicUdiDi>426242965P01TWINA5</basicUdiDi>
    <tradeName>Explorer Twin Module, Large, without Spacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>macu4 GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038447</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4262429650082</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:05:51.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262429650099</udiDi>
    <basicUdiDi>426242965P01TWINA5</basicUdiDi>
    <tradeName>Exporer Twin Module, Large, with Spacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>macu4 GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038447</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4262429650099</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:05:51.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262429650112</udiDi>
    <basicUdiDi>426242965P01SWIM9U</basicUdiDi>
    <tradeName>Explorer Swim Module, Small, without Spacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>macu4 GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038447</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4262429650112</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:05:51.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262429650150</udiDi>
    <basicUdiDi>426242965P01PINCHFA</basicUdiDi>
    <tradeName>Explorer Pinch Module, Standard, with Spacer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>macu4 GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038447</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4262429650150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:05:51.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262429650297</udiDi>
    <basicUdiDi>426242965P01RING7J</basicUdiDi>
    <tradeName>Explorer Ring EXP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>macu4 GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038447</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4262429650297</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:05:51.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081781870</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Child, Right, Medium, 7</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>Y061809</emdnCode>
    <emdnDescription>WRIST DISARTICULATION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH99</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:16:18.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081782488</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Women, Left, Medium, 2</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>Y061809</emdnCode>
    <emdnDescription>WRIST DISARTICULATION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH160</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:16:17.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783362</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Women, Right, Large, 2</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>Y061809</emdnCode>
    <emdnDescription>WRIST DISARTICULATION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH248</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:15:57.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081783973</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Left, Large, c1</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>Y061809</emdnCode>
    <emdnDescription>WRIST DISARTICULATION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH309</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:15:56.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784581</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 14</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>Y061809</emdnCode>
    <emdnDescription>WRIST DISARTICULATION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH370</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:15:55.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081786059</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Cover, Medium, 12</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>Y061809</emdnCode>
    <emdnDescription>WRIST DISARTICULATION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHC38</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:15:52.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081789302</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cover, Small, Travelling Tracks</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>Y061809</emdnCode>
    <emdnDescription>WRIST DISARTICULATION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAC37</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:15:30.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971592715</udiDi>
    <basicUdiDi>805797159EBY5</basicUdiDi>
    <tradeName>ThunderCell Battery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>EB02-P-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T03:22:22.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971592722</udiDi>
    <basicUdiDi>805797159EBY5</basicUdiDi>
    <tradeName>ThunderCell Battery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>EB02-W-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T03:22:22.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>50553482004578</udiDi>
    <basicUdiDi>50553482ASCTU</basicUdiDi>
    <tradeName>Partial foot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hugh Steeper Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010196</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>ASC29</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:20:28.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>50553482004714</udiDi>
    <basicUdiDi>50553482ASCTU</basicUdiDi>
    <tradeName>Finger (premium) 2 digits</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hugh Steeper Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010196</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>ASC71F-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:20:28.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>50553482004882</udiDi>
    <basicUdiDi>50553482ASCTU</basicUdiDi>
    <tradeName>Partial foot - carbon foot pl</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hugh Steeper Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010196</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>ASC29CF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:20:28.327Z</lastUpdated>
  </row>
</eudamedExport>