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    <udiDi>00850022994005</udiDi>
    <basicUdiDi>B-00850022994005</basicUdiDi>
    <tradeName>GPG</tradeName>
    <deviceName>Zurich Pressure Guidewire System, Model 100</deviceName>
    <manufacturerName>Zurich Medical</manufacturerName>
    <manufacturerSrn>US-MF-000012091</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00308</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:40.740Z</lastUpdated>
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    <udiDi>07540184010318</udiDi>
    <basicUdiDi>B-07540184010318</basicUdiDi>
    <tradeName>07540184010318</tradeName>
    <deviceName>OptoWire III Pressure Guidewire</deviceName>
    <manufacturerName>Opsens Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000018361</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F1031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:42.364Z</lastUpdated>
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    <udiDi>07540184010110</udiDi>
    <basicUdiDi>B-07540184010110</basicUdiDi>
    <tradeName>07540184010110</tradeName>
    <deviceName>OptoWire Deux Pressure Guidewire with Gauge Connector</deviceName>
    <manufacturerName>Opsens Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000018361</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F1011</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:36.354Z</lastUpdated>
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    <udiDi>06956014468166</udiDi>
    <basicUdiDi>B-06956014468166</basicUdiDi>
    <tradeName>Shun R</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>626816</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:04:07.737Z</lastUpdated>
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    <udiDi>06956014468159</udiDi>
    <basicUdiDi>B-06956014468159</basicUdiDi>
    <tradeName>Shun R</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>626815</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:04:06.481Z</lastUpdated>
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  <row>
    <udiDi>06956014468142</udiDi>
    <basicUdiDi>B-06956014468142</basicUdiDi>
    <tradeName>Shun R</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>626814</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:04:05.283Z</lastUpdated>
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    <udiDi>06956014468135</udiDi>
    <basicUdiDi>B-06956014468135</basicUdiDi>
    <tradeName>Shun R</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>626813</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:04:04.081Z</lastUpdated>
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  <row>
    <udiDi>06956014468128</udiDi>
    <basicUdiDi>B-06956014468128</basicUdiDi>
    <tradeName>Shun CP12</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>626812</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:58.074Z</lastUpdated>
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  <row>
    <udiDi>06956014468111</udiDi>
    <basicUdiDi>B-06956014468111</basicUdiDi>
    <tradeName>Shun CP12</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>626811</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:56.861Z</lastUpdated>
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  <row>
    <udiDi>06956014468104</udiDi>
    <basicUdiDi>B-06956014468104</basicUdiDi>
    <tradeName>Shun CP12</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>626810</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:55.678Z</lastUpdated>
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    <udiDi>06956014468098</udiDi>
    <basicUdiDi>B-06956014468098</basicUdiDi>
    <tradeName>Shun CP</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>626809</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:54.468Z</lastUpdated>
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  <row>
    <udiDi>06956014468081</udiDi>
    <basicUdiDi>B-06956014468081</basicUdiDi>
    <tradeName>Shun CP</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>626808</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:48.476Z</lastUpdated>
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  <row>
    <udiDi>06956014468074</udiDi>
    <basicUdiDi>B-06956014468074</basicUdiDi>
    <tradeName>Shun CP</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>626807</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:47.271Z</lastUpdated>
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  <row>
    <udiDi>06956014468067</udiDi>
    <basicUdiDi>B-06956014468067</basicUdiDi>
    <tradeName>Shun GA3</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>626806</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:46.083Z</lastUpdated>
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    <udiDi>06956014468050</udiDi>
    <basicUdiDi>B-06956014468050</basicUdiDi>
    <tradeName>Shun GA3</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>626805</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:44.859Z</lastUpdated>
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    <udiDi>06956014468043</udiDi>
    <basicUdiDi>B-06956014468043</basicUdiDi>
    <tradeName>Shun GA2</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>626804</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:38.859Z</lastUpdated>
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    <udiDi>06956014468036</udiDi>
    <basicUdiDi>B-06956014468036</basicUdiDi>
    <tradeName>Shun GA2</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>626803</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:37.685Z</lastUpdated>
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    <udiDi>06956014468029</udiDi>
    <basicUdiDi>B-06956014468029</basicUdiDi>
    <tradeName>06956014468029</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>626802</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:36.455Z</lastUpdated>
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    <udiDi>06956014468012</udiDi>
    <basicUdiDi>B-06956014468012</basicUdiDi>
    <tradeName>06956014468012</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>626801</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:35.253Z</lastUpdated>
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    <udiDi>06956014468005</udiDi>
    <basicUdiDi>B-06956014468005</basicUdiDi>
    <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>
    <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>626800</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:03:29.261Z</lastUpdated>
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