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    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
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    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
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    <lastUpdated>2026-07-01T21:34:36.167Z</lastUpdated>
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    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:36.122Z</lastUpdated>
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    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635763</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:36.101Z</lastUpdated>
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    <tradeName>SafeCut</tradeName>
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    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635764</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:36.079Z</lastUpdated>
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    <tradeName>SafeCut</tradeName>
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    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635765</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:36.053Z</lastUpdated>
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    <basicUdiDi>69560144CCBDCKH</basicUdiDi>
    <tradeName>SafeCut</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635766</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:36.031Z</lastUpdated>
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    <tradeName>SafeCut</tradeName>
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    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635767</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:36.007Z</lastUpdated>
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    <basicUdiDi>69560144CCBDCKH</basicUdiDi>
    <tradeName>SafeCut</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635768</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:35.981Z</lastUpdated>
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    <udiDi>06956014457696</udiDi>
    <basicUdiDi>69560144CCBDCKH</basicUdiDi>
    <tradeName>SafeCut</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635769</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:35.955Z</lastUpdated>
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    <udiDi>06956014457702</udiDi>
    <basicUdiDi>69560144CCBDCKH</basicUdiDi>
    <tradeName>SafeCut</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635770</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:35.920Z</lastUpdated>
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    <udiDi>06956014458013</udiDi>
    <basicUdiDi>B-06956014458013</basicUdiDi>
    <tradeName>Shun Guider</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>615801</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:35.897Z</lastUpdated>
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    <udiDi>06956014458037</udiDi>
    <basicUdiDi>B-06956014458037</basicUdiDi>
    <tradeName>Shun Guider</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>615803</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:35.874Z</lastUpdated>
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    <udiDi>06956014458044</udiDi>
    <basicUdiDi>B-06956014458044</basicUdiDi>
    <tradeName>Shun Guider</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>615804</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:35.850Z</lastUpdated>
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    <udiDi>06956014458051</udiDi>
    <basicUdiDi>B-06956014458051</basicUdiDi>
    <tradeName>Shun Guider</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>615805</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:35.827Z</lastUpdated>
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    <udiDi>06956014458112</udiDi>
    <basicUdiDi>B-06956014458112</basicUdiDi>
    <tradeName>Shun Guider</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>615811</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:35.799Z</lastUpdated>
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    <udiDi>06956014458129</udiDi>
    <basicUdiDi>B-06956014458129</basicUdiDi>
    <tradeName>Shun Guider</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>615812</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:35.776Z</lastUpdated>
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    <tradeName>Shun Guider</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>615816</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:35.748Z</lastUpdated>
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    <basicUdiDi>B-06956014458204</basicUdiDi>
    <tradeName>Shun Guider</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>615820</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:35.718Z</lastUpdated>
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    <basicUdiDi>B-06956014458211</basicUdiDi>
    <tradeName>Shun Guider</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>615821</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:35.696Z</lastUpdated>
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