<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05690967084691</udiDi>
    <basicUdiDi>5690967BU00076NS</basicUdiDi>
    <tradeName>Icelock® 125 Ratchet Fabrication Kit Without Braid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Össur Iceland ehf.</manufacturerName>
    <manufacturerSrn>IS-MF-000000173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062499</emdnCode>
    <emdnDescription>LOWER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L-180001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:34:16.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>05690967077204</udiDi>
    <basicUdiDi>5690967BU00009NB</basicUdiDi>
    <tradeName>Iceross® Interface Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Össur Iceland ehf.</manufacturerName>
    <manufacturerSrn>IS-MF-000000173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062499</emdnCode>
    <emdnDescription>LOWER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-190200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:34:16.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>05690967075286</udiDi>
    <basicUdiDi>5690967BU00008N9</basicUdiDi>
    <tradeName>Iceross® Distal Cup</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Össur Iceland ehf.</manufacturerName>
    <manufacturerSrn>IS-MF-000000173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062499</emdnCode>
    <emdnDescription>LOWER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-300006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:34:14.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404036500131</udiDi>
    <basicUdiDi>54040365PD00001TC</basicUdiDi>
    <tradeName>Lunaris IO</tradeName>
    <deviceName>Lunaris IO</deviceName>
    <manufacturerName>Axiles Bionics BV</manufacturerName>
    <manufacturerSrn>BE-MF-000025722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LUNC4SXXZ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:59:12.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404036502845</udiDi>
    <basicUdiDi>54040365PD00003TG</basicUdiDi>
    <tradeName>Lunaris Essential</tradeName>
    <deviceName>Lunaris Essential</deviceName>
    <manufacturerName>Axiles Bionics BV</manufacturerName>
    <manufacturerSrn>BE-MF-000025722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LESC4SXXZ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:59:09.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404036500124</udiDi>
    <basicUdiDi>54040365PD00001TC</basicUdiDi>
    <tradeName>Lunaris IO</tradeName>
    <deviceName>Lunaris IO</deviceName>
    <manufacturerName>Axiles Bionics BV</manufacturerName>
    <manufacturerSrn>BE-MF-000025722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LUNC3SXXZ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:51:00.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404036502838</udiDi>
    <basicUdiDi>54040365PD00003TG</basicUdiDi>
    <tradeName>Lunaris Essential</tradeName>
    <deviceName>Lunaris Essential</deviceName>
    <manufacturerName>Axiles Bionics BV</manufacturerName>
    <manufacturerSrn>BE-MF-000025722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LESC3SXXZ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:50:58.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404036502821</udiDi>
    <basicUdiDi>54040365PD00003TG</basicUdiDi>
    <tradeName>Lunaris Essential</tradeName>
    <deviceName>Lunaris Essential</deviceName>
    <manufacturerName>Axiles Bionics BV</manufacturerName>
    <manufacturerSrn>BE-MF-000025722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LESC2SXXZ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:46:22.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404036500117</udiDi>
    <basicUdiDi>54040365PD00001TC</basicUdiDi>
    <tradeName>Lunaris IO</tradeName>
    <deviceName>Lunaris IO</deviceName>
    <manufacturerName>Axiles Bionics BV</manufacturerName>
    <manufacturerSrn>BE-MF-000025722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LUNC2SXXZ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:46:21.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055348202079</udiDi>
    <basicUdiDi>50553482COS000AG</basicUdiDi>
    <tradeName>SPLIT TF SKIN+ 22/23 LT S E4</tradeName>
    <deviceName>External limb prosthesis finishing component, non-customized</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>Y062499</emdnCode>
    <emdnDescription>LOWER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLC22LS/E4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:15:57.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>05050649100093</udiDi>
    <basicUdiDi>5050649MINIBLADEXTJL</basicUdiDi>
    <tradeName>MINI BLADE XT EXT. FOOT PROSTHESIS 1 BL</tradeName>
    <deviceName>Mini BladeXT</deviceName>
    <manufacturerName>Blatchford Products Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000048777</manufacturerSrn>
    <authorisedRepresentativeName>Blatchford Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006292</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBXTAB1SM</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:01:18.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>05050649095207</udiDi>
    <basicUdiDi>5050649ELITEBLADEVT9W</basicUdiDi>
    <tradeName>VT FEMALE CAT 1 EXT. PROSTHESIS CONN.</tradeName>
    <deviceName>Elite BladeVT</deviceName>
    <manufacturerName>Blatchford Products Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000048777</manufacturerSrn>
    <authorisedRepresentativeName>Blatchford Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006292</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTF1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:01:14.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>05050649094989</udiDi>
    <basicUdiDi>5050649TTPRO3L</basicUdiDi>
    <tradeName>TT PRO PYR EXT. PROS'S ROTATOR SHOCK 1P</tradeName>
    <deviceName>TT Pro</deviceName>
    <manufacturerName>Blatchford Products Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000048777</manufacturerSrn>
    <authorisedRepresentativeName>Blatchford Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006292</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062499</emdnCode>
    <emdnDescription>LOWER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TTPRO - PYR1P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:01:14.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>05050649092848</udiDi>
    <basicUdiDi>5050649SMARTIP2Q</basicUdiDi>
    <tradeName>SMARTIP 4B 30mm EXTERNAL KNEE PROSTHESIS</tradeName>
    <deviceName>SmartIP</deviceName>
    <manufacturerName>Blatchford Products Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000048777</manufacturerSrn>
    <authorisedRepresentativeName>Blatchford Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006292</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMARTIP4B30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:01:13.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>05050649091261</udiDi>
    <basicUdiDi>5050649SUPERSACHWC</basicUdiDi>
    <tradeName>SUPER SACH EXT. FOOT PROSTHESIS 22L LT</tradeName>
    <deviceName>SuperSACH</deviceName>
    <manufacturerName>Blatchford Products Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000048777</manufacturerSrn>
    <authorisedRepresentativeName>Blatchford Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006292</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P529101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:01:07.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>05050649091087</udiDi>
    <basicUdiDi>5050649ORION3W7</basicUdiDi>
    <tradeName>ORION3 EXTERNAL KNEE PROSTHESIS</tradeName>
    <deviceName>ORION3 EXTERNAL KNEE PROSTHESIS</deviceName>
    <manufacturerName>Blatchford Products Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000048777</manufacturerSrn>
    <authorisedRepresentativeName>Blatchford Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006292</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ORION3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:01:06.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>05050649057991</udiDi>
    <basicUdiDi>5050649ESKBU</basicUdiDi>
    <tradeName>ESK+ 4B DMTBLE LESS CYL 30mm</tradeName>
    <deviceName>ESK+</deviceName>
    <manufacturerName>Blatchford Products Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000048777</manufacturerSrn>
    <authorisedRepresentativeName>Blatchford Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006292</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESK4B30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:01:06.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>05050649034145</udiDi>
    <basicUdiDi>5050649ECHELONVT6Y</basicUdiDi>
    <tradeName>ECH VT 22L1 CAT1-EXT. FOOT PROSTHESIS</tradeName>
    <deviceName>Echelon VT</deviceName>
    <manufacturerName>Blatchford Products Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000048777</manufacturerSrn>
    <authorisedRepresentativeName>Blatchford Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006292</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECVT22L11S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:01:05.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>05050649017674</udiDi>
    <basicUdiDi>5050649MERCURYYB</basicUdiDi>
    <tradeName>REX2 HYD SWING &amp; STANCE SERV EX  (REX 2)</tradeName>
    <deviceName>Mercury</deviceName>
    <manufacturerName>Blatchford Products Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000048777</manufacturerSrn>
    <authorisedRepresentativeName>Blatchford Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006292</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>932283</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:01:01.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>05050649017650</udiDi>
    <basicUdiDi>5050649KX06V2NB</basicUdiDi>
    <tradeName>SWING &amp; STANCE HYD CYLINDER FOR KX06</tradeName>
    <deviceName>KX06</deviceName>
    <manufacturerName>Blatchford Products Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000048777</manufacturerSrn>
    <authorisedRepresentativeName>Blatchford Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006292</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>932281</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:01:00.485Z</lastUpdated>
  </row>
</eudamedExport>