<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04895200307112</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Large Cylinder O Ring</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S500-SPN011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:40.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200306023</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Flexion Stop Bumper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S400L-SPN003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:40.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200391388</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Polycentric 4 Bar Manual Locking Knee Joint(CNC)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S400LC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:40.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200306016</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Bolt Washer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S400L-SPN002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:40.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200307167</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Spring Base O Ring</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S500-SPN016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:40.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200306153</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Lock Handle Spring</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S400L-SPN017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:40.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200305989</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Socket Attachment Plate (KD)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S400L=SP-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:40.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200305972</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Polycentric 4 Bar Manual Locking Knee Joint (SP)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S400L=SP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:40.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200306139</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Lock Handle Set Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S400L-SPN015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:40.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200305965</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Lotus Adaptor(KD)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S400L=LA-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:40.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200391258</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Polycentric 4 Bar Manual Locking Knee Joint without Adaptor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S400LNP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:40.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200306078</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Ext. Assist. Spring</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S400L-SPN008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:40.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200307181</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Polycentric 5 Bar Pneumatic Knee Joint w/ Stance Flexion</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:25.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200308997</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Lock set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S700L-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:25.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200300175</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Single axis Hip Joint (titanium)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>6S1-T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:25.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200309031</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Lotus Adaptor(KD)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S700L=LA-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:25.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200306986</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Polycentric 4 Bar Pneumatic Knee Joint (SP)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S500=SP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:25.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200309321</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Single Axis Mechanical Hip Joint with Lock</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-02-H1SL-L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:25.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200308430</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Pyramid Adaptor(AK)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S700-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:25.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200306962</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Polycentric 4 Bar Pneumatic Knee Joint (LA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>2-01-S500=LA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:25.638Z</lastUpdated>
  </row>
</eudamedExport>