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    <tradeName>Scoreflex NC</tradeName>
    <deviceName>Scoreflex NC</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>627-104-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:33:49.861Z</lastUpdated>
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    <udiDi>08719244950119</udiDi>
    <basicUdiDi>B-08719244950119</basicUdiDi>
    <tradeName>Scoreflex NC</tradeName>
    <deviceName>Scoreflex NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:33:43.863Z</lastUpdated>
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    <udiDi>08719244950102</udiDi>
    <basicUdiDi>B-08719244950102</basicUdiDi>
    <tradeName>Scoreflex NC</tradeName>
    <deviceName>Scoreflex NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:33:42.648Z</lastUpdated>
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    <udiDi>08719244950096</udiDi>
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    <tradeName>Scoreflex NC</tradeName>
    <deviceName>Scoreflex NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
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    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>625-104-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:33:41.458Z</lastUpdated>
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    <udiDi>08719244950089</udiDi>
    <basicUdiDi>B-08719244950089</basicUdiDi>
    <tradeName>Scoreflex NC</tradeName>
    <deviceName>Scoreflex NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622-204-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:33:40.244Z</lastUpdated>
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    <udiDi>08719244950072</udiDi>
    <basicUdiDi>B-08719244950072</basicUdiDi>
    <tradeName>Scoreflex NC</tradeName>
    <deviceName>Scoreflex NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622-154-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:33:34.240Z</lastUpdated>
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    <udiDi>08719244950065</udiDi>
    <basicUdiDi>B-08719244950065</basicUdiDi>
    <tradeName>Scoreflex NC</tradeName>
    <deviceName>Scoreflex NC</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>622-104-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:33:33.042Z</lastUpdated>
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    <udiDi>08719244950058</udiDi>
    <basicUdiDi>B-08719244950058</basicUdiDi>
    <tradeName>Scoreflex NC</tradeName>
    <deviceName>Scoreflex NC</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>620-204-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:33:31.849Z</lastUpdated>
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    <udiDi>08719244950041</udiDi>
    <basicUdiDi>B-08719244950041</basicUdiDi>
    <tradeName>Scoreflex NC</tradeName>
    <deviceName>Scoreflex NC</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>620-154-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:33:30.645Z</lastUpdated>
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    <udiDi>08719244950034</udiDi>
    <basicUdiDi>B-08719244950034</basicUdiDi>
    <tradeName>Scoreflex NC</tradeName>
    <deviceName>Scoreflex NC</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>620-104-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:33:24.642Z</lastUpdated>
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    <udiDi>08719244950027</udiDi>
    <basicUdiDi>B-08719244950027</basicUdiDi>
    <tradeName>Scoreflex NC</tradeName>
    <deviceName>Scoreflex NC</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>617-204-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:33:23.466Z</lastUpdated>
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    <udiDi>08719244950010</udiDi>
    <basicUdiDi>B-08719244950010</basicUdiDi>
    <tradeName>Scoreflex NC</tradeName>
    <deviceName>Scoreflex NC</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>617-154-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:33:22.236Z</lastUpdated>
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    <udiDi>08719244950003</udiDi>
    <basicUdiDi>B-08719244950003</basicUdiDi>
    <tradeName>Scoreflex NC</tradeName>
    <deviceName>Scoreflex NC</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>617-104-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:33:21.057Z</lastUpdated>
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    <udiDi>08717853297670</udiDi>
    <basicUdiDi>B-08717853297670</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-382-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:29:08.869Z</lastUpdated>
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    <udiDi>08717853297663</udiDi>
    <basicUdiDi>B-08717853297663</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-332-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:29:07.716Z</lastUpdated>
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    <udiDi>08717853297656</udiDi>
    <basicUdiDi>B-08717853297656</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-282-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:29:00.469Z</lastUpdated>
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    <udiDi>08717853297649</udiDi>
    <basicUdiDi>B-08717853297649</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-232-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:59.262Z</lastUpdated>
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    <udiDi>08717853297632</udiDi>
    <basicUdiDi>B-08717853297632</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-182-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:58.065Z</lastUpdated>
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    <udiDi>08717853297625</udiDi>
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    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:56.859Z</lastUpdated>
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    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
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    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-132-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:50.888Z</lastUpdated>
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