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    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232-103-5UJ</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:00:17.969Z</lastUpdated>
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    <udiDi>06934955942822</udiDi>
    <basicUdiDi>B-06934955942822</basicUdiDi>
    <tradeName>Sapphire II PRO</tradeName>
    <deviceName></deviceName>
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    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <lastUpdated>2026-08-03T00:00:17.941Z</lastUpdated>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName></deviceName>
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    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
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    <udiDi>06934955942846</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
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    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-103-5UJ</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:00:17.907Z</lastUpdated>
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    <udiDi>06934955942853</udiDi>
    <basicUdiDi>B-06934955942853</basicUdiDi>
    <tradeName>Sapphire II PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-153-5UJ</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:00:17.885Z</lastUpdated>
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    <udiDi>06934955942860</udiDi>
    <basicUdiDi>B-06934955942860</basicUdiDi>
    <tradeName>Sapphire II PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-203-5UJ</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:00:17.855Z</lastUpdated>
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    <udiDi>06934955942877</udiDi>
    <basicUdiDi>B-06934955942877</basicUdiDi>
    <tradeName>Sapphire II PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-303-5UJ</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:00:17.822Z</lastUpdated>
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    <udiDi>06934955942884</udiDi>
    <basicUdiDi>B-06934955942884</basicUdiDi>
    <tradeName>Sapphire II PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-103-5UJ</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:00:17.797Z</lastUpdated>
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    <udiDi>06934955942891</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-153-5UJ</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:00:17.778Z</lastUpdated>
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    <udiDi>06934955942907</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-203-5UJ</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:00:17.731Z</lastUpdated>
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    <udiDi>06934955949012</udiDi>
    <basicUdiDi>B-06934955949012</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215-084-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.727Z</lastUpdated>
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    <udiDi>06934955949029</udiDi>
    <basicUdiDi>B-06934955949029</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215-104-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.702Z</lastUpdated>
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    <udiDi>06934955949036</udiDi>
    <basicUdiDi>B-06934955949036</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215-124-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.683Z</lastUpdated>
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    <udiDi>06934955949043</udiDi>
    <basicUdiDi>B-06934955949043</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215-154-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.655Z</lastUpdated>
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    <udiDi>06934955949050</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215-184-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.630Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215-224-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.606Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
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    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215-264-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.585Z</lastUpdated>
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    <udiDi>06934955949081</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>217-084-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.546Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
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    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>217-104-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.489Z</lastUpdated>
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    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>217-124-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.462Z</lastUpdated>
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