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    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>SACH Foot (Pediatric, No Toe)</tradeName>
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    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
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    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>04895200300922</udiDi>
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    <tradeName>SACH Foot (Pediatric, No Toe)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0-01-FTT-NT-L-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:10.117Z</lastUpdated>
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    <udiDi>04895200301035</udiDi>
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    <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-17B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:10.104Z</lastUpdated>
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  <row>
    <udiDi>04895200301134</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-16B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:10.091Z</lastUpdated>
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    <udiDi>04895200301066</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-13</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:10.081Z</lastUpdated>
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    <udiDi>04895200301264</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-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:10.068Z</lastUpdated>
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    <udiDi>04895200304593</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>2-01-4S40-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:10.050Z</lastUpdated>
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  <row>
    <udiDi>04895200300670</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Pyramid 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-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:10.035Z</lastUpdated>
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  <row>
    <udiDi>04895200305330</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Polycentric 4 Bar Manual Locking Knee Joint</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:10.022Z</lastUpdated>
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  <row>
    <udiDi>04895200304319</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Single Axis Knee Joint w/Stance Ctrl &amp; Constant Friction(TI)</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>2-01-4S1T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:10.007Z</lastUpdated>
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  <row>
    <udiDi>04895200304555</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Single Axis Lock Knee Joint</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>2-01-4S40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.996Z</lastUpdated>
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    <udiDi>04895200305996</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>2-01-S400L-SPN001 to 2-01-S400L-SPN018 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-S400L-SPK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.980Z</lastUpdated>
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    <udiDi>04895200305897</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>
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    <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-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.964Z</lastUpdated>
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    <udiDi>04895200304340</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>4 Bar Mechanical Knee Joint - KD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2-01-4S21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.942Z</lastUpdated>
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    <udiDi>04895200310440</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-36</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.919Z</lastUpdated>
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    <udiDi>04895200310617</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>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3090L-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.896Z</lastUpdated>
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    <udiDi>04895200310211</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-34</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:09.844Z</lastUpdated>
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    <udiDi>04895200310600</udiDi>
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    <tradeName>TRANSFEMORAL Silicone Liner – Forte</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3090L-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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