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    <tradeName>Sapphire II (RX)</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>234-R-2520J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.789Z</lastUpdated>
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    <udiDi>06934955921278</udiDi>
    <basicUdiDi>B-06934955921278</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>234-R-2530J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.760Z</lastUpdated>
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    <udiDi>06934955921285</udiDi>
    <basicUdiDi>B-06934955921285</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-2710J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.729Z</lastUpdated>
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    <udiDi>06934955921292</udiDi>
    <basicUdiDi>B-06934955921292</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-2715J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.706Z</lastUpdated>
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    <udiDi>06934955921308</udiDi>
    <basicUdiDi>B-06934955921308</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-2720J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.673Z</lastUpdated>
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    <udiDi>06934955921315</udiDi>
    <basicUdiDi>B-06934955921315</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-3010J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.628Z</lastUpdated>
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    <udiDi>06934955921322</udiDi>
    <basicUdiDi>B-06934955921322</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-3012J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.566Z</lastUpdated>
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    <udiDi>06934955921339</udiDi>
    <basicUdiDi>B-06934955921339</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-3015J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.510Z</lastUpdated>
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    <udiDi>06934955921346</udiDi>
    <basicUdiDi>B-06934955921346</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-3020J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.455Z</lastUpdated>
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    <udiDi>06934955921353</udiDi>
    <basicUdiDi>B-06934955921353</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-3030J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.395Z</lastUpdated>
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    <udiDi>06934955921360</udiDi>
    <basicUdiDi>B-06934955921360</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-3210J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.358Z</lastUpdated>
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  <row>
    <udiDi>06934955921377</udiDi>
    <basicUdiDi>B-06934955921377</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-3215J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955921384</udiDi>
    <basicUdiDi>B-06934955921384</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-3220J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.259Z</lastUpdated>
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  <row>
    <udiDi>06934955921391</udiDi>
    <basicUdiDi>B-06934955921391</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-3510J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.231Z</lastUpdated>
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  <row>
    <udiDi>06934955921407</udiDi>
    <basicUdiDi>B-06934955921407</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-3515J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.200Z</lastUpdated>
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  <row>
    <udiDi>06934955921414</udiDi>
    <basicUdiDi>B-06934955921414</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-3520J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.175Z</lastUpdated>
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    <udiDi>06934955921421</udiDi>
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    <tradeName>Sapphire II (RX)</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>234-R-3530J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.157Z</lastUpdated>
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    <udiDi>06934955921438</udiDi>
    <basicUdiDi>B-06934955921438</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-4010J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.127Z</lastUpdated>
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    <udiDi>06934955921445</udiDi>
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    <tradeName>Sapphire II (RX)</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>234-R-4015J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.066Z</lastUpdated>
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    <udiDi>06934955921452</udiDi>
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    <tradeName>Sapphire II (RX)</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>234-R-4020J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.038Z</lastUpdated>
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