<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04895200310563</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSFEMORAL Silicone Liner – Forte</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3090L-32</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200310389</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSTIBIAL and TRANSFEMORAL Silicone Locking Liner</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3030L-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200310433</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSFEMORAL Silicone Cushion Liner – Parasil</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3070C-34</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200310334</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSTIBIAL and TRANSFEMORAL Silicone Locking Liner</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3030L-30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200310549</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSFEMORAL Silicone Locking Liner – Parasil</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3070L-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200310372</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSTIBIAL and TRANSFEMORAL Silicone Locking Liner</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3030L-38</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200310464</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSFEMORAL Silicone Cushion Liner – Parasil</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3070C-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200310358</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSTIBIAL and TRANSFEMORAL Silicone Locking Liner</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3030L-34</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200310471</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSFEMORAL Silicone Cushion Liner – Parasil</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3070C-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200310273</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSTIBIAL and TRANSFEMORAL Silicone Locking Liner</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3030L-21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200310235</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSTIBIAL and TRANSFEMORAL Silicone Cushion Liner</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3030C-38</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200310228</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSTIBIAL and TRANSFEMORAL Silicone Cushion Liner</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3030C-36</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200314240</udiDi>
    <basicUdiDi>48952003006RV7Q</basicUdiDi>
    <tradeName>Friction Wrist Connector (for prosthetic socket lamination)</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>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4-02-WC-IM-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200314264</udiDi>
    <basicUdiDi>48952003006RV7Q</basicUdiDi>
    <tradeName>Friction Wrist Connector (for prosthetic socket lamination)</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>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4-02-WC-MT-M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200315223</udiDi>
    <basicUdiDi>48952003006RV7Q</basicUdiDi>
    <tradeName>Cosmetic prostheses for upper arm</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>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6-01-EJ2N-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897027550047</udiDi>
    <basicUdiDi>48952003006RV7Q</basicUdiDi>
    <tradeName>Above Elbow Harness</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>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6-04-AEH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200301042</udiDi>
    <basicUdiDi>48952003001RK69</basicUdiDi>
    <tradeName>SACH Foot (Pediatric, No Toe)</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0-01-FTT-NT-R-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200301431</udiDi>
    <basicUdiDi>48952003001RK69</basicUdiDi>
    <tradeName>Attachment Block (Pediatric)</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0-02-A22C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200301318</udiDi>
    <basicUdiDi>48952003001RK69</basicUdiDi>
    <tradeName>SACH Foot (Pediatric, Open Toe)</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0-01-FTT-R-19B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200300861</udiDi>
    <basicUdiDi>48952003001RK69</basicUdiDi>
    <tradeName>SACH Foot (Pediatric, Open Toe)</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>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0-01-FTT-L-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.370Z</lastUpdated>
  </row>
</eudamedExport>