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    <tradeName>Scoreflex</tradeName>
    <deviceName>Scoreflex</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>630-153-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:23:02.647Z</lastUpdated>
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    <udiDi>08717853292446</udiDi>
    <basicUdiDi>B-08717853292446</basicUdiDi>
    <tradeName>Scoreflex</tradeName>
    <deviceName>Scoreflex</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>630-103-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:22:56.629Z</lastUpdated>
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    <udiDi>08717853292439</udiDi>
    <basicUdiDi>B-08717853292439</basicUdiDi>
    <tradeName>Scoreflex</tradeName>
    <deviceName>Scoreflex</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>625-203-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:22:55.446Z</lastUpdated>
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    <udiDi>08717853292422</udiDi>
    <basicUdiDi>B-08717853292422</basicUdiDi>
    <tradeName>Scoreflex</tradeName>
    <deviceName>Scoreflex</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>625-153-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:22:54.233Z</lastUpdated>
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    <udiDi>08717853292415</udiDi>
    <basicUdiDi>B-08717853292415</basicUdiDi>
    <tradeName>Scoreflex</tradeName>
    <deviceName>Scoreflex</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>625-103-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:22:53.062Z</lastUpdated>
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    <udiDi>08717853292408</udiDi>
    <basicUdiDi>B-08717853292408</basicUdiDi>
    <tradeName>Scoreflex</tradeName>
    <deviceName>Scoreflex</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>620-203-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:22:47.058Z</lastUpdated>
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    <udiDi>08717853292392</udiDi>
    <basicUdiDi>B-08717853292392</basicUdiDi>
    <tradeName>Scoreflex</tradeName>
    <deviceName>Scoreflex</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>620-153-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:22:45.841Z</lastUpdated>
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    <udiDi>08717853292385</udiDi>
    <basicUdiDi>B-08717853292385</basicUdiDi>
    <tradeName>Scoreflex</tradeName>
    <deviceName>Scoreflex</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>620-103-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:22:44.654Z</lastUpdated>
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    <udiDi>08717853292750</udiDi>
    <basicUdiDi>B-08717853292750</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230-123-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.079Z</lastUpdated>
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    <udiDi>08717853297687</udiDi>
    <basicUdiDi>B-08717853297687</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620F-15X-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:53.067Z</lastUpdated>
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    <udiDi>08717853297694</udiDi>
    <basicUdiDi>B-08717853297694</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620F-15N-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:53.040Z</lastUpdated>
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    <udiDi>08717853297700</udiDi>
    <basicUdiDi>B-08717853297700</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620F-20X-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:53.018Z</lastUpdated>
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    <udiDi>08717853297717</udiDi>
    <basicUdiDi>B-08717853297717</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620F-20N-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:52.993Z</lastUpdated>
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  <row>
    <udiDi>08717853297724</udiDi>
    <basicUdiDi>B-08717853297724</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620F-40X-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:52.960Z</lastUpdated>
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    <udiDi>08717853297731</udiDi>
    <basicUdiDi>B-08717853297731</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620F-40N-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:52.923Z</lastUpdated>
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    <udiDi>08717853297748</udiDi>
    <basicUdiDi>B-08717853297748</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>625F-15X-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:52.890Z</lastUpdated>
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    <udiDi>08717853297755</udiDi>
    <basicUdiDi>B-08717853297755</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>625F-15N-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:52.857Z</lastUpdated>
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    <udiDi>08717853297762</udiDi>
    <basicUdiDi>B-08717853297762</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>625F-20X-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:52.826Z</lastUpdated>
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    <udiDi>08717853297779</udiDi>
    <basicUdiDi>B-08717853297779</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>625F-20N-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:52.795Z</lastUpdated>
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    <udiDi>08717853297786</udiDi>
    <basicUdiDi>B-08717853297786</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>625F-40X-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:52.764Z</lastUpdated>
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