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    <manufacturerName>Abbott Medical</manufacturerName>
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    <authorisedRepresentativeName>Abbott Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008744</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020280</emdnCode>
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    <lastUpdated>2026-09-21T20:14:01.634Z</lastUpdated>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>1214</reference>
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    <lastUpdated>2026-09-21T19:25:13.159Z</lastUpdated>
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    <basicUdiDi>5415067SCS0001L4</basicUdiDi>
    <tradeName>NA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Medical</manufacturerName>
    <manufacturerSrn>US-MF-000028918</manufacturerSrn>
    <authorisedRepresentativeName>Abbott Medical</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020280</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3599</reference>
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    <lastUpdated>2026-09-21T19:25:12.503Z</lastUpdated>
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    <udiDi>05415067040749</udiDi>
    <basicUdiDi>5415067SCS0001L4</basicUdiDi>
    <tradeName>NA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Medical</manufacturerName>
    <manufacturerSrn>US-MF-000028918</manufacturerSrn>
    <authorisedRepresentativeName>Abbott Medical</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020280</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-09-21T19:25:12.266Z</lastUpdated>
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    <udiDi>00763000984694</udiDi>
    <basicUdiDi>0763000B000020674</basicUdiDi>
    <tradeName>Inceptiv™</tradeName>
    <deviceName>Implantable Spinal Neurostimulator</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>J02020201</emdnCode>
    <emdnDescription>FULLY IMPLANTABLE SPINAL NEUROSTIMULATORS, RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>977119</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:41:01.896Z</lastUpdated>
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    <tradeName>Intellis™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>FULLY IMPLANTABLE SPINAL NEUROSTIMULATORS, RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>977118</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:40:39.985Z</lastUpdated>
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    <basicUdiDi>0763000B000020674</basicUdiDi>
    <tradeName>Inceptiv™</tradeName>
    <deviceName></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>J02020201</emdnCode>
    <emdnDescription>FULLY IMPLANTABLE SPINAL NEUROSTIMULATORS, RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>977119</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:40:39.683Z</lastUpdated>
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    <basicUdiDi>0763000B000020674</basicUdiDi>
    <tradeName>Inceptiv™</tradeName>
    <deviceName></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>J02020201</emdnCode>
    <emdnDescription>FULLY IMPLANTABLE SPINAL NEUROSTIMULATORS, RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>977119</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:39:04.604Z</lastUpdated>
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    <udiDi>00763000984700</udiDi>
    <basicUdiDi>0763000B000020674</basicUdiDi>
    <tradeName>Inceptiv™</tradeName>
    <deviceName></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>J02020201</emdnCode>
    <emdnDescription>FULLY IMPLANTABLE SPINAL NEUROSTIMULATORS, RECHARGEABLE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>977119</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:38:38.451Z</lastUpdated>
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    <udiDi>00763000478087</udiDi>
    <basicUdiDi>B-00763000478087</basicUdiDi>
    <tradeName>Vanta™  AdaptiveStim™</tradeName>
    <deviceName>Vanta INS</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J02020202</emdnCode>
    <emdnDescription>FULLY IMPLANTABLE SPINAL NEUROSTIMULATORSS, NOT RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>977006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:07:18.601Z</lastUpdated>
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    <udiDi>00643169781719</udiDi>
    <basicUdiDi>B-00643169781719</basicUdiDi>
    <tradeName>Intellis™ AdaptiveStim®</tradeName>
    <deviceName>Implantable Spinal Neurostimulator</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J02020201</emdnCode>
    <emdnDescription>FULLY IMPLANTABLE SPINAL NEUROSTIMULATORS, RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>97715</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:07:07.424Z</lastUpdated>
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    <udiDi>09352307000735</udiDi>
    <basicUdiDi>B-09352307000735</basicUdiDi>
    <tradeName>Evoke® Charger (AU)</tradeName>
    <deviceName>Evoke® Charger (AU)</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020280</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:16.071Z</lastUpdated>
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    <udiDi>09352307000421</udiDi>
    <basicUdiDi>B-09352307000421</basicUdiDi>
    <tradeName>Evoke® Charger (UK)</tradeName>
    <deviceName>Evoke® Charger (UK)</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020280</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:14.549Z</lastUpdated>
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    <udiDi>09352307000261</udiDi>
    <basicUdiDi>B-09352307000261</basicUdiDi>
    <tradeName>Evoke® Lead Adapter Kit</tradeName>
    <deviceName>Evoke® Lead Adapter Kit</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020280</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1028</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:13.745Z</lastUpdated>
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    <udiDi>09352307000216</udiDi>
    <basicUdiDi>B-09352307000216</basicUdiDi>
    <tradeName>Evoke® External Closed Loop Stimulator (eCLS)</tradeName>
    <deviceName>Evoke® External Closed Loop Stimulator (eCLS)</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020299</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:12.173Z</lastUpdated>
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    <udiDi>09352307000209</udiDi>
    <basicUdiDi>B-09352307000209</basicUdiDi>
    <tradeName>Evoke® 12C Trial Percutaneous Lead Kit - 90cm</tradeName>
    <deviceName>Evoke® 12C Trial Percutaneous Lead Kit - 90cm</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020203</emdnCode>
    <emdnDescription>SPINAL NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1017</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:09.752Z</lastUpdated>
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    <basicUdiDi>B-09352307000186</basicUdiDi>
    <tradeName>Evoke® 12C Trial Percutaneous Lead Kit - 60cm</tradeName>
    <deviceName>Evoke® 12C Trial Percutaneous Lead Kit - 60cm</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020203</emdnCode>
    <emdnDescription>SPINAL NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1016</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:08.203Z</lastUpdated>
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    <udiDi>09352307000162</udiDi>
    <basicUdiDi>B-09352307000162</basicUdiDi>
    <tradeName>Evoke® Spares Kit</tradeName>
    <deviceName>Evoke® Spares Kit</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020280</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:07.348Z</lastUpdated>
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