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    <basicUdiDi>B-08858788502047</basicUdiDi>
    <tradeName>Hydra</tradeName>
    <deviceName>aortic valve loading system</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYDRA18VLS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:51.431Z</lastUpdated>
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    <udiDi>08858788502030</udiDi>
    <basicUdiDi>B-08858788502030</basicUdiDi>
    <tradeName>Hydra</tradeName>
    <deviceName>Hydra aortic valve delivery catheter</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYDRA18F</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:50.228Z</lastUpdated>
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    <udiDi>08858788502023</udiDi>
    <basicUdiDi>B-08858788502023</basicUdiDi>
    <tradeName>HYDRA Aortic Valve</tradeName>
    <deviceName>Hydra aortic valve</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301030204</emdnCode>
    <emdnDescription>STENTED BIOLOGICAL TRICUSPID VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYDRA30</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:44.221Z</lastUpdated>
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    <udiDi>08858788502016</udiDi>
    <basicUdiDi>B-08858788502016</basicUdiDi>
    <tradeName>HYDRA Aortic Valve</tradeName>
    <deviceName>Hydra aortic valve</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301030204</emdnCode>
    <emdnDescription>STENTED BIOLOGICAL TRICUSPID VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYDRA26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:43.020Z</lastUpdated>
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  <row>
    <udiDi>08858788502009</udiDi>
    <basicUdiDi>B-08858788502009</basicUdiDi>
    <tradeName>HYDRA Aortic Valve</tradeName>
    <deviceName>Hydra aortic valve</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301030204</emdnCode>
    <emdnDescription>STENTED BIOLOGICAL TRICUSPID VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYDRA22</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:41.816Z</lastUpdated>
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    <udiDi>08858788501224</udiDi>
    <basicUdiDi>B-08858788501224</basicUdiDi>
    <tradeName>Cocoon</tradeName>
    <deviceName>Accessory Set for PFO Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPF9F</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:40.626Z</lastUpdated>
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    <udiDi>08858788501217</udiDi>
    <basicUdiDi>B-08858788501217</basicUdiDi>
    <tradeName>Cocoon</tradeName>
    <deviceName>Accessory Set for PFO Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPF8F</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:34.623Z</lastUpdated>
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    <udiDi>08858788500876</udiDi>
    <basicUdiDi>B-08858788500876</basicUdiDi>
    <tradeName>Cocoon</tradeName>
    <deviceName>Accessory Set for VSD Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVII8F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:33.422Z</lastUpdated>
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    <udiDi>08858788500869</udiDi>
    <basicUdiDi>B-08858788500869</basicUdiDi>
    <tradeName>Cocoon</tradeName>
    <deviceName>Accessory Set for VSD Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVII7F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:32.215Z</lastUpdated>
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    <udiDi>08858788500852</udiDi>
    <basicUdiDi>B-08858788500852</basicUdiDi>
    <tradeName>Cocoon</tradeName>
    <deviceName>Accessory Set for VSD Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVII6F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:31.014Z</lastUpdated>
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  <row>
    <udiDi>08858788500777</udiDi>
    <basicUdiDi>B-08858788500777</basicUdiDi>
    <tradeName>Cocoon PFO Occluder</tradeName>
    <deviceName>Cocoon PFO Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040303</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88587885PFP7</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:25.321Z</lastUpdated>
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    <udiDi>08858788500760</udiDi>
    <basicUdiDi>B-08858788500760</basicUdiDi>
    <tradeName>Cocoon PFO Occluders</tradeName>
    <deviceName>Cocoon PFO Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040303</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPF2525</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:23.812Z</lastUpdated>
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    <udiDi>08858788500692</udiDi>
    <basicUdiDi>B-08858788500692</basicUdiDi>
    <tradeName>Cocoon PFO Occluder</tradeName>
    <deviceName>Cocoon PFO Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040303</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPF35</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:22.606Z</lastUpdated>
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    <udiDi>08858788500685</udiDi>
    <basicUdiDi>B-08858788500685</basicUdiDi>
    <tradeName>Cocoon PFO Occluder</tradeName>
    <deviceName>Cocoon PFO Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040303</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPF30</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:21.420Z</lastUpdated>
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    <udiDi>08858788500678</udiDi>
    <basicUdiDi>B-08858788500678</basicUdiDi>
    <tradeName>Cocoon</tradeName>
    <deviceName>Cocoon PFO Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040303</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPF25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:15.403Z</lastUpdated>
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    <udiDi>08858788500661</udiDi>
    <basicUdiDi>B-08858788500661</basicUdiDi>
    <tradeName>Cocoon</tradeName>
    <deviceName>Cocoon PFO Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040303</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPF18</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:14.204Z</lastUpdated>
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    <udiDi>08858788500593</udiDi>
    <basicUdiDi>B-08858788500593</basicUdiDi>
    <tradeName>Cocoon VSD Occluders</tradeName>
    <deviceName>Cocoon VSD Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040301</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, VENTRICULAR SEPTAL DEFECTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV1210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:13.002Z</lastUpdated>
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    <udiDi>08858788500586</udiDi>
    <basicUdiDi>B-08858788500586</basicUdiDi>
    <tradeName>Cocoon VSD Occluders</tradeName>
    <deviceName>Cocoon VSD Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040301</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, VENTRICULAR SEPTAL DEFECTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV1010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:11.806Z</lastUpdated>
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    <udiDi>08858788500579</udiDi>
    <basicUdiDi>B-08858788500579</basicUdiDi>
    <tradeName>Cocoon VSD Occluders</tradeName>
    <deviceName>Cocoon VSD Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040301</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, VENTRICULAR SEPTAL DEFECTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV0810</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:05.790Z</lastUpdated>
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    <udiDi>08858788500562</udiDi>
    <basicUdiDi>B-08858788500562</basicUdiDi>
    <tradeName>Cocoon VSD Occluders</tradeName>
    <deviceName>Cocoon VSD Occluders</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040301</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, VENTRICULAR SEPTAL DEFECTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV0610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:23:04.599Z</lastUpdated>
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