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    <basicUdiDi>697116281BID10AJ</basicUdiDi>
    <tradeName>06936841227839</tradeName>
    <deviceName>Balloon Inflation Device</deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104010280</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:17:37.153Z</lastUpdated>
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    <udiDi>06942265516282</udiDi>
    <basicUdiDi>695848140065MK</basicUdiDi>
    <tradeName>Parafleet SC 035</tradeName>
    <deviceName>Atropos Pro / Parafleet SC 035 PTA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>BrosMed Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007501</manufacturerSrn>
    <authorisedRepresentativeName>Brosmed Medical B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002616</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F35-030020-070</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:36:45.134Z</lastUpdated>
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    <udiDi>06942265514257</udiDi>
    <basicUdiDi>695848140064MH</basicUdiDi>
    <tradeName>Parafleet SC 018</tradeName>
    <deviceName>Minerva Pro / Parafleet SC 018 PTA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>BrosMed Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007501</manufacturerSrn>
    <authorisedRepresentativeName>Brosmed Medical B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002616</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F18-100040-150</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:36:41.125Z</lastUpdated>
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    <udiDi>06942265500014</udiDi>
    <basicUdiDi>695848140063MF</basicUdiDi>
    <tradeName>Parafleet SC 014</tradeName>
    <deviceName>Polux Pro / Parafleet SC 014 PTA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>BrosMed Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007501</manufacturerSrn>
    <authorisedRepresentativeName>Brosmed Medical B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002616</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F14-010015-070</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:36:40.337Z</lastUpdated>
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    <udiDi>06956014455197</udiDi>
    <basicUdiDi>69560144CCBDCKH</basicUdiDi>
    <tradeName>SafeCut</tradeName>
    <deviceName>Coronary Cutting Balloon Dilatation Catheter</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>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635519</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:29:56.750Z</lastUpdated>
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    <udiDi>06956014457474</udiDi>
    <basicUdiDi>69560144GECZF</basicUdiDi>
    <tradeName>Slender</tradeName>
    <deviceName>Guiding Extention Catheter</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>MDR 2017/745</legislation>
    <emdnCode>C0104010202</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635747</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:29:54.450Z</lastUpdated>
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    <udiDi>06949450407189</udiDi>
    <basicUdiDi>69494504RYC1801YK</basicUdiDi>
    <tradeName>SealingPro</tradeName>
    <deviceName>SealingPro™ Y Connector</deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009046</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040180</emdnCode>
    <emdnDescription>CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18821100</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:14:07.695Z</lastUpdated>
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    <udiDi>06949450407158</udiDi>
    <basicUdiDi>69494504RYC1803YP</basicUdiDi>
    <tradeName>SealingPro</tradeName>
    <deviceName>SealingPro™ Y Connector</deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009046</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040180</emdnCode>
    <emdnDescription>CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18471100</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:14:03.678Z</lastUpdated>
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    <udiDi>06949450407134</udiDi>
    <basicUdiDi>69494504RYC1802YM</basicUdiDi>
    <tradeName>SealingPro</tradeName>
    <deviceName>SealingPro™ Y Connector</deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009046</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040180</emdnCode>
    <emdnDescription>CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18992200</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:14:02.973Z</lastUpdated>
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    <udiDi>06931896161992</udiDi>
    <basicUdiDi>69494504IFD19R6</basicUdiDi>
    <tradeName>Enlarger™Pro</tradeName>
    <deviceName>Enlarger™ Inflation Device</deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009046</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040180</emdnCode>
    <emdnDescription>CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2052050S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:06:52.953Z</lastUpdated>
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  <row>
    <udiDi>06931896111034</udiDi>
    <basicUdiDi>69494504SC107QW</basicUdiDi>
    <tradeName>Tresfort™</tradeName>
    <deviceName>Tresfort™ 18 PTA Balloon Catheter</deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009046</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107200200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:06:51.366Z</lastUpdated>
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    <udiDi>06943718272014</udiDi>
    <basicUdiDi>69437182VelutFS</basicUdiDi>
    <tradeName>06943718272014</tradeName>
    <deviceName>PTA Balloon Dilatation Catheters</deviceName>
    <manufacturerName>Beijing Demax Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005844</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMC03020-35040</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:40:38.565Z</lastUpdated>
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  <row>
    <udiDi>06936733794104</udiDi>
    <basicUdiDi>69367337LP0024ML</basicUdiDi>
    <tradeName>Angiopower™</tradeName>
    <deviceName>Inflation Device</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104010280</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LP-P-30</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:21.946Z</lastUpdated>
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    <udiDi>06936733776001</udiDi>
    <basicUdiDi>69367337LP0034MP</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LS061638</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:20.349Z</lastUpdated>
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    <udiDi>06936733775035</udiDi>
    <basicUdiDi>69367337LP0019MT</basicUdiDi>
    <tradeName>Angioway™</tradeName>
    <deviceName>Contrast Medium Injection Manifold Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MK-018</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:13.941Z</lastUpdated>
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    <udiDi>06936733775004</udiDi>
    <basicUdiDi>69367337LP0018MR</basicUdiDi>
    <tradeName>Angioway™</tradeName>
    <deviceName>Contrast Medium Injection Manifold Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MK-006</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:11.538Z</lastUpdated>
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    <udiDi>06936733748022</udiDi>
    <basicUdiDi>69367337LP0033MM</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS041135-HS45-IC18-K-S</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:09.142Z</lastUpdated>
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    <basicUdiDi>69367337LP0030MF</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS040525</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:05.134Z</lastUpdated>
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    <udiDi>06936733747971</udiDi>
    <basicUdiDi>69367337LP0035MR</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LS062338-SJ70-IN18-K-S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:03.531Z</lastUpdated>
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    <udiDi>06936733741122</udiDi>
    <basicUdiDi>69367337LP0032MK</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS061135-NJ45-IN18</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:58:47.343Z</lastUpdated>
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