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    <tradeName>IMPERIA-M Delivery System</tradeName>
    <deviceName>IMPERIA Delivery System</deviceName>
    <manufacturerName>NVT GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005426</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL-AO18G2115M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:04:27.518Z</lastUpdated>
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    <tradeName>ALLEGRA Delivery System TF</tradeName>
    <deviceName>ALLEGRA Delivery System transfemoral (TF)</deviceName>
    <manufacturerName>NVT GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005426</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL-AO18G1RE1150</reference>
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    <lastUpdated>2026-07-30T23:04:22.691Z</lastUpdated>
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    <basicUdiDi>B-18904224938431</basicUdiDi>
    <tradeName>Navigator™ INCEPTION</tradeName>
    <deviceName>Navigator™  INCEPTION  Transcatheter Heart Valve Delivery System</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVIS224530</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:01:56.821Z</lastUpdated>
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    <basicUdiDi>B-18904224938370</basicUdiDi>
    <tradeName>Navigator™ INCEPTION</tradeName>
    <deviceName>Navigator™ INCEPTION Transcatheter Heart Valve Delivery System</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVTI229035</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:01:55.230Z</lastUpdated>
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    <basicUdiDi>B-18904224938394</basicUdiDi>
    <tradeName>Navigator™ INCEPTION</tradeName>
    <deviceName>Navigator™ INCEPTION Transcatheter Heart Valve Delivery System</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</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>NVTI232035</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:01:54.433Z</lastUpdated>
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    <udiDi>00850035587041</udiDi>
    <basicUdiDi>08500355876311107A</basicUdiDi>
    <tradeName>Valve Loading Tool</tradeName>
    <deviceName>Valve Loading Tool</deviceName>
    <manufacturerName>HighLife</manufacturerName>
    <manufacturerSrn>FR-MF-000015887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038099</emdnCode>
    <emdnDescription>HEART VALVE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>631110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:22:56.935Z</lastUpdated>
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    <basicUdiDi>0763000B00026938T</basicUdiDi>
    <tradeName>Avalus Ultra™</tradeName>
    <deviceName>Avalus Ultra Sizers</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038001</emdnCode>
    <emdnDescription>HEART VALVE IMPLANT SIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7400SU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:07:36.685Z</lastUpdated>
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    <basicUdiDi>0763000B00010977W</basicUdiDi>
    <tradeName>Harmony™</tradeName>
    <deviceName>Harmony Delivery Catheter System</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HARMONY-DCS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:06:58.638Z</lastUpdated>
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    <basicUdiDi>0763000B00010927L</basicUdiDi>
    <tradeName>Avalus™</tradeName>
    <deviceName>Avalus sizers</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038001</emdnCode>
    <emdnDescription>HEART VALVE IMPLANT SIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7400S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:06:49.263Z</lastUpdated>
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    <basicUdiDi>01915060000000000000567NR</basicUdiDi>
    <tradeName>ACURATE Prime™</tradeName>
    <deviceName>ACURATE Prime Loading Kit</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H749396942325</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:31.728Z</lastUpdated>
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    <udiDi>00191506019419</udiDi>
    <basicUdiDi>01915060000000000000260MU</basicUdiDi>
    <tradeName>ACURATE neo2™</tradeName>
    <deviceName>ACURATE neo2™ Loading Kit</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYM-AC-010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:55:01.229Z</lastUpdated>
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    <udiDi>18904224971902</udiDi>
    <basicUdiDi>B-18904224971902</basicUdiDi>
    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</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>NVS133535</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:35.178Z</lastUpdated>
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    <basicUdiDi>B-18904224971889</basicUdiDi>
    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVT133535</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:30.841Z</lastUpdated>
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    <basicUdiDi>B-18904224971896</basicUdiDi>
    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
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    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVT135035</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:30.045Z</lastUpdated>
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    <basicUdiDi>B-18904224971872</basicUdiDi>
    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVS33535</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:28.420Z</lastUpdated>
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    <basicUdiDi>B-18904224971865</basicUdiDi>
    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVT35035</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:27.890Z</lastUpdated>
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    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
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    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVT33535</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:23.619Z</lastUpdated>
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    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
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    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVS135035</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:09.219Z</lastUpdated>
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    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
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    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVS35035</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:08.415Z</lastUpdated>
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    <tradeName>CrocoDial Compass™</tradeName>
    <deviceName>CrocoDial Compass™</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCDC2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:15:08.125Z</lastUpdated>
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