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    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <udiDi>04895200301004</udiDi>
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    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
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    <udiDi>04895200315506</udiDi>
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    <tradeName>Mechanical hand – voluntary opening (with PVCIH)</tradeName>
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    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>04895200300878</udiDi>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0-01-FTT-L-17B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.312Z</lastUpdated>
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    <udiDi>04895200301110</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-15B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.295Z</lastUpdated>
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  <row>
    <udiDi>04895200301288</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-18</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.281Z</lastUpdated>
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    <udiDi>04895200300625</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Pediatric 4 Bar Knee Joint with Manual 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>0-00-4S40C=LA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.269Z</lastUpdated>
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    <udiDi>04895200305903</udiDi>
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    <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-S400L-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.256Z</lastUpdated>
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    <udiDi>04895200304333</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Cable</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-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.243Z</lastUpdated>
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    <udiDi>04895200300601</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>0-00-4S40C-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.230Z</lastUpdated>
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  <row>
    <udiDi>04895200300618</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>0-00-4S40C-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.216Z</lastUpdated>
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  <row>
    <udiDi>04895200300687</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Pediatric 4 Bar 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>0-00-4S41C=LA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.196Z</lastUpdated>
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  <row>
    <udiDi>04895200304418</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>2-01-4S23-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.183Z</lastUpdated>
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    <udiDi>04895200305934</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Polycentric 4 Bar 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-S400=LA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.165Z</lastUpdated>
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    <udiDi>04895200304425</udiDi>
    <basicUdiDi>48952003002RM6J</basicUdiDi>
    <tradeName>Lock set</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>
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    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2-01-4S23-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.142Z</lastUpdated>
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    <udiDi>04895200391180</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>
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    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3092L-36</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.123Z</lastUpdated>
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    <udiDi>04895200310266</udiDi>
    <basicUdiDi>48952003003RP6V</basicUdiDi>
    <tradeName>TRANSTIBIAL and TRANSFEMORAL Silicone Cushion Liner</tradeName>
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    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3030C-44</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.107Z</lastUpdated>
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    <udiDi>04895200310280</udiDi>
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    <tradeName>TRANSTIBIAL and TRANSFEMORAL Silicone Locking Liner</tradeName>
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    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3030L-22</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>04895200310594</udiDi>
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    <tradeName>TRANSFEMORAL Silicone Liner – Forte</tradeName>
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    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3090L-38</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.079Z</lastUpdated>
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    <udiDi>04895200310518</udiDi>
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    <tradeName>TRANSFEMORAL Silicone Locking Liner – Parasil</tradeName>
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    <manufacturerName>Regal Prosthesis Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000028642</manufacturerSrn>
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    <emdnCode>Y062409</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-01-3070L-36</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:56:07.067Z</lastUpdated>
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