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    <tradeName>Sapphire NC 24</tradeName>
    <deviceName>Sapphire NC 24</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-124-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:38:10.424Z</lastUpdated>
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    <tradeName>Sapphire NC 24</tradeName>
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    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <tradeName>Sapphire NC 24</tradeName>
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    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
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    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-01T00:38:00.824Z</lastUpdated>
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    <udiDi>08719244951376</udiDi>
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    <tradeName>Sapphire NC 24</tradeName>
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    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-224-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:37:59.615Z</lastUpdated>
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    <udiDi>08719244951369</udiDi>
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    <tradeName>Sapphire NC 24</tradeName>
    <deviceName>Sapphire NC 24</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-184-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:37:53.613Z</lastUpdated>
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    <udiDi>08719244951352</udiDi>
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    <tradeName>Sapphire NC 24</tradeName>
    <deviceName>Sapphire NC 24</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-154-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:37:52.408Z</lastUpdated>
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    <udiDi>08719244951345</udiDi>
    <basicUdiDi>B-08719244951345</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName>Sapphire NC 24</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-124-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:37:51.237Z</lastUpdated>
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    <udiDi>08719244951338</udiDi>
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    <tradeName>Sapphire NC 24</tradeName>
    <deviceName>Sapphire NC 24</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-104-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:37:50.113Z</lastUpdated>
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    <udiDi>08719244951321</udiDi>
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    <tradeName>Sapphire NC 24</tradeName>
    <deviceName>Sapphire NC 24</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-084-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:37:41.609Z</lastUpdated>
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    <udiDi>08719244951314</udiDi>
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    <tradeName>Sapphire NC 24</tradeName>
    <deviceName>Sapphire NC 24</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222-264-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:37:40.406Z</lastUpdated>
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    <udiDi>08719244951307</udiDi>
    <basicUdiDi>B-08719244951307</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName>Sapphire NC 24</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222-224-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:37:39.207Z</lastUpdated>
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    <udiDi>08719244951291</udiDi>
    <basicUdiDi>B-08719244951291</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName>Sapphire NC 24</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222-184-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:37:38.004Z</lastUpdated>
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    <udiDi>08719244951284</udiDi>
    <basicUdiDi>B-08719244951284</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName>Sapphire NC 24</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222-154-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:37:29.712Z</lastUpdated>
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    <udiDi>08719244951277</udiDi>
    <basicUdiDi>B-08719244951277</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName>Sapphire NC 24</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>222-124-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:37:27.209Z</lastUpdated>
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    <udiDi>08719244951260</udiDi>
    <basicUdiDi>B-08719244951260</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName>Sapphire NC 24</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:37:25.990Z</lastUpdated>
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    <udiDi>08719244951253</udiDi>
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    <lastUpdated>2026-07-01T00:37:24.800Z</lastUpdated>
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    <tradeName>Sapphire NC 24</tradeName>
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    <tradeName>Sapphire NC 24</tradeName>
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    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>220-184-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:37:12.779Z</lastUpdated>
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