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<eudamedExport entity="devices">
  <row>
    <udiDi>04895200391173</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSFEMORAL Soft Silicone Liner – Adapt</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>3-01-3092L-34</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200315551</udiDi>
    <basicUdiDi>48952003006RV7Q</basicUdiDi>
    <tradeName>Mechanical hand voluntary opening (with PVCIH)</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>6-02-MH1-MT-L-M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200315520</udiDi>
    <basicUdiDi>48952003006RV7Q</basicUdiDi>
    <tradeName>Mechanical hand – voluntary opening (with PVCIH)</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>6-02-MH1-IM-R-M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200314257</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-L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200314233</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-M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200300984</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-L-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:06.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200301028</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-L-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:06.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200301240</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-16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:06.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200301011</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-L-16B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:06.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200301424</udiDi>
    <basicUdiDi>48952003001RK69</basicUdiDi>
    <tradeName>Male Socket Adaptor - SS (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-A1SC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:06.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200300960</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-L-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:06.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200301233</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-15B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:06.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200300946</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-L-13</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:06.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200300694</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>3-Prong 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>0-00-4S41C=LA-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:57.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200305323</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-S400-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:57.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200304685</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Cable 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>2-01-4S40J-SPN004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:57.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200304623</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>2-01-4S40J-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:57.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200304654</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Extension 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>2-01-4S40J-SPN001A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:57.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200304371</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Anchor plate</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>2-01-4S21-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:57.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895200304630</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>2-01-4S40J-SPN001 to 2-01-4S40J-SPN004 Part 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>2-01-4S40J-SPK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:55:57.038Z</lastUpdated>
  </row>
</eudamedExport>