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    <deviceName>PTCA Guide Wire</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>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>626801</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:35.253Z</lastUpdated>
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    <tradeName>Shun FC®</tradeName>
    <deviceName>PTCA Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <lastUpdated>2026-06-28T20:03:29.261Z</lastUpdated>
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    <tradeName>Shun FC®</tradeName>
    <deviceName>PTCA Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
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    <tradeName>Shun S03</tradeName>
    <deviceName>PTCA Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626798</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:26.872Z</lastUpdated>
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    <udiDi>06956014467978</udiDi>
    <basicUdiDi>B-06956014467978</basicUdiDi>
    <tradeName>Shun S03</tradeName>
    <deviceName>PTCA Guide Wire</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>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626797</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:25.644Z</lastUpdated>
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    <udiDi>06956014467961</udiDi>
    <basicUdiDi>B-06956014467961</basicUdiDi>
    <tradeName>Shun S03</tradeName>
    <deviceName>PTCA Guide Wire</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>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626796</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:19.638Z</lastUpdated>
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    <basicUdiDi>B-06956014467954</basicUdiDi>
    <tradeName>Shun S03</tradeName>
    <deviceName>PTCA Guide Wire</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>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626795</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:18.501Z</lastUpdated>
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    <udiDi>06956014467947</udiDi>
    <basicUdiDi>B-06956014467947</basicUdiDi>
    <tradeName>Shun F</tradeName>
    <deviceName>PTCA Guide Wire</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>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626794</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:17.291Z</lastUpdated>
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    <udiDi>06956014467930</udiDi>
    <basicUdiDi>B-06956014467930</basicUdiDi>
    <tradeName>Shun F</tradeName>
    <deviceName>PTCA Guide Wire</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>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626793</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:16.055Z</lastUpdated>
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    <udiDi>06956014467923</udiDi>
    <basicUdiDi>B-06956014467923</basicUdiDi>
    <tradeName>Shun F</tradeName>
    <deviceName>PTCA Guide Wire</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>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626792</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:10.039Z</lastUpdated>
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    <udiDi>06956014467916</udiDi>
    <basicUdiDi>B-06956014467916</basicUdiDi>
    <tradeName>Shun Pi 150</tradeName>
    <deviceName>PTCA Guide Wire</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>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626791</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:08.866Z</lastUpdated>
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    <udiDi>06956014467909</udiDi>
    <basicUdiDi>B-06956014467909</basicUdiDi>
    <tradeName>Shun Pi 150</tradeName>
    <deviceName>PTCA Guide Wire</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>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626790</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:07.630Z</lastUpdated>
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    <udiDi>06956014467893</udiDi>
    <basicUdiDi>B-06956014467893</basicUdiDi>
    <tradeName>Shun Pi 150</tradeName>
    <deviceName>PTCA Guide Wire</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>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626789</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:06.463Z</lastUpdated>
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    <udiDi>06956014467886</udiDi>
    <basicUdiDi>B-06956014467886</basicUdiDi>
    <tradeName>Shun Pi 50</tradeName>
    <deviceName>PTCA Guide Wire</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>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626788</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:00.443Z</lastUpdated>
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    <udiDi>06956014467879</udiDi>
    <basicUdiDi>B-06956014467879</basicUdiDi>
    <tradeName>Shun Pi 50</tradeName>
    <deviceName>PTCA Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626787</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:02:59.232Z</lastUpdated>
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    <udiDi>06956014467862</udiDi>
    <basicUdiDi>B-06956014467862</basicUdiDi>
    <tradeName>Shun Pi 50</tradeName>
    <deviceName>PTCA Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626786</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:02:58.043Z</lastUpdated>
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    <tradeName>Shun Pi 200</tradeName>
    <deviceName>PTCA Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626785</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:02:56.835Z</lastUpdated>
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    <tradeName>Shun Pi 200</tradeName>
    <deviceName>PTCA Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626784</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:02:50.836Z</lastUpdated>
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    <tradeName>Shun Pi 200</tradeName>
    <deviceName>PTCA Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626783</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:02:49.619Z</lastUpdated>
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    <tradeName>Shun Pi 200</tradeName>
    <deviceName>PTCA Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
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    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626782</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:02:48.446Z</lastUpdated>
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