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    <basicUdiDi>B-05425025750160</basicUdiDi>
    <tradeName>VNS Therapy®</tradeName>
    <deviceName>NCP® Programming Wand</deviceName>
    <manufacturerName>LivaNova USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038770</manufacturerSrn>
    <authorisedRepresentativeName>LivaNova Belgium NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014035</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020701</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:48:10.314Z</lastUpdated>
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    <udiDi>05425025750153</udiDi>
    <basicUdiDi>B-05425025750153</basicUdiDi>
    <tradeName>VNS Therapy®</tradeName>
    <deviceName>VNS Therapy® PerenniaFLEX® Lead</deviceName>
    <manufacturerName>LivaNova USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038770</manufacturerSrn>
    <authorisedRepresentativeName>LivaNova Belgium NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014035</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020302</emdnCode>
    <emdnDescription>VAGAL NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>304-30</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:48:09.510Z</lastUpdated>
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    <udiDi>05425025750139</udiDi>
    <basicUdiDi>B-05425025750139</basicUdiDi>
    <tradeName>VNS Therapy®</tradeName>
    <deviceName>VNS Therapy® PerenniaFLEX® Lead</deviceName>
    <manufacturerName>LivaNova USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038770</manufacturerSrn>
    <authorisedRepresentativeName>LivaNova Belgium NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014035</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020302</emdnCode>
    <emdnDescription>VAGAL NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>304-20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:48:05.512Z</lastUpdated>
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    <udiDi>05425025750122</udiDi>
    <basicUdiDi>B-05425025750122</basicUdiDi>
    <tradeName>VNS Therapy®</tradeName>
    <deviceName>VNS Therapy® PerenniaDURA® Lead</deviceName>
    <manufacturerName>LivaNova USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038770</manufacturerSrn>
    <authorisedRepresentativeName>LivaNova Belgium NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014035</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020302</emdnCode>
    <emdnDescription>VAGAL NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303-30</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:48:04.711Z</lastUpdated>
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    <udiDi>05425025750115</udiDi>
    <basicUdiDi>B-05425025750115</basicUdiDi>
    <tradeName>VNS Therapy®</tradeName>
    <deviceName>VNS Therapy® PerenniaDURA® Lead</deviceName>
    <manufacturerName>LivaNova USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038770</manufacturerSrn>
    <authorisedRepresentativeName>LivaNova Belgium NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014035</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020302</emdnCode>
    <emdnDescription>VAGAL NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303-20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:48:03.905Z</lastUpdated>
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    <udiDi>05425025750108</udiDi>
    <basicUdiDi>B-05425025750108</basicUdiDi>
    <tradeName>VNS Therapy®</tradeName>
    <deviceName>VNS Therapy® Lead</deviceName>
    <manufacturerName>LivaNova USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038770</manufacturerSrn>
    <authorisedRepresentativeName>LivaNova Belgium NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014035</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020380</emdnCode>
    <emdnDescription>VAGAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>302-30</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:48:03.104Z</lastUpdated>
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    <udiDi>05425025750054</udiDi>
    <basicUdiDi>B-05425025750054</basicUdiDi>
    <tradeName>VNS Therapy®</tradeName>
    <deviceName>VNS Therapy® AspireHC® Generator</deviceName>
    <manufacturerName>LivaNova USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038770</manufacturerSrn>
    <authorisedRepresentativeName>LivaNova Belgium NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014035</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020399</emdnCode>
    <emdnDescription>VAGAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:47:59.207Z</lastUpdated>
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    <udiDi>05425025750092</udiDi>
    <basicUdiDi>B-05425025750092</basicUdiDi>
    <tradeName>VNS Therapy®</tradeName>
    <deviceName>VNS Therapy® Lead</deviceName>
    <manufacturerName>LivaNova USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038770</manufacturerSrn>
    <authorisedRepresentativeName>LivaNova Belgium NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014035</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020380</emdnCode>
    <emdnDescription>VAGAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>302-20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:47:57.506Z</lastUpdated>
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    <udiDi>05425025750061</udiDi>
    <basicUdiDi>B-05425025750061</basicUdiDi>
    <tradeName>VNS Therapy®</tradeName>
    <deviceName>VNS Therapy® AspireSR® Generator</deviceName>
    <manufacturerName>LivaNova USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038770</manufacturerSrn>
    <authorisedRepresentativeName>LivaNova Belgium NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014035</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020301</emdnCode>
    <emdnDescription>DRUG-RESISTANT EPILEPSY NON-SURGICAL THERAPY IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:47:56.813Z</lastUpdated>
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    <udiDi>05425025750047</udiDi>
    <basicUdiDi>B-05425025750047</basicUdiDi>
    <tradeName>VNS Therapy®</tradeName>
    <deviceName>VNS Therapy® Demipulse Duo® Generator</deviceName>
    <manufacturerName>LivaNova USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038770</manufacturerSrn>
    <authorisedRepresentativeName>LivaNova Belgium NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014035</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020399</emdnCode>
    <emdnDescription>VAGAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:47:41.441Z</lastUpdated>
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    <udiDi>05425025750030</udiDi>
    <basicUdiDi>B-05425025750030</basicUdiDi>
    <tradeName>VNS Therapy®</tradeName>
    <deviceName>VNS Therapy® Demipulse® Generator</deviceName>
    <manufacturerName>LivaNova USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038770</manufacturerSrn>
    <authorisedRepresentativeName>LivaNova Belgium NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014035</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020399</emdnCode>
    <emdnDescription>VAGAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:47:39.848Z</lastUpdated>
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    <udiDi>05425025750023</udiDi>
    <basicUdiDi>B-05425025750023</basicUdiDi>
    <tradeName>VNS Therapy®</tradeName>
    <deviceName>VNS Therapy® Pulse Duo™ Generator</deviceName>
    <manufacturerName>LivaNova USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038770</manufacturerSrn>
    <authorisedRepresentativeName>LivaNova Belgium NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014035</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020301</emdnCode>
    <emdnDescription>DRUG-RESISTANT EPILEPSY NON-SURGICAL THERAPY IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102R</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:47:39.040Z</lastUpdated>
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    <udiDi>05425025750016</udiDi>
    <basicUdiDi>B-05425025750016</basicUdiDi>
    <tradeName>VNS Therapy®</tradeName>
    <deviceName>VNS Therapy® Pulse™ Generator</deviceName>
    <manufacturerName>LivaNova USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038770</manufacturerSrn>
    <authorisedRepresentativeName>LivaNova Belgium NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014035</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020399</emdnCode>
    <emdnDescription>VAGAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:47:36.686Z</lastUpdated>
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    <udiDi>05060116920659</udiDi>
    <basicUdiDi>B-05060116920659</basicUdiDi>
    <tradeName>05060116920659</tradeName>
    <deviceName>TheraSphere Administration Set (B Braun)</deviceName>
    <manufacturerName>Biocompatibles UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000052971</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0502</emdnCode>
    <emdnDescription>BRACHYTHERAPY ADMINISTRATION KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OTT-SPE-FP-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:51:18.823Z</lastUpdated>
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    <udiDi>05060116920642</udiDi>
    <basicUdiDi>B-05060116920642</basicUdiDi>
    <tradeName>TheraSphere Administration Set (B Braun)</tradeName>
    <deviceName>TheraSphere Administration Set (B Braun)</deviceName>
    <manufacturerName>Biocompatibles UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000052971</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0502</emdnCode>
    <emdnDescription>BRACHYTHERAPY ADMINISTRATION KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OTT-SPE-FP-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:51:18.032Z</lastUpdated>
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    <udiDi>05060116920635</udiDi>
    <basicUdiDi>B-05060116920635</basicUdiDi>
    <tradeName>05060116920635</tradeName>
    <deviceName>TheraSphere Administration Set (B Braun)</deviceName>
    <manufacturerName>Biocompatibles UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000052971</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0502</emdnCode>
    <emdnDescription>BRACHYTHERAPY ADMINISTRATION KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OTT-SPE-FP-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:51:17.233Z</lastUpdated>
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    <udiDi>05060116920628</udiDi>
    <basicUdiDi>B-05060116920628</basicUdiDi>
    <tradeName>05060116920628</tradeName>
    <deviceName>TheraSphere Yttrium-90 Glass Microspheres</deviceName>
    <manufacturerName>Biocompatibles UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000052971</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OTT-SPE-FP-700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:51:16.425Z</lastUpdated>
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    <udiDi>05060116920611</udiDi>
    <basicUdiDi>B-05060116920611</basicUdiDi>
    <tradeName>05060116920611</tradeName>
    <deviceName>TheraSphere Yttrium-90 Glass Microspheres</deviceName>
    <manufacturerName>Biocompatibles UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000052971</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OTT-SPE-FP-700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:51:12.426Z</lastUpdated>
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    <udiDi>05060116920604</udiDi>
    <basicUdiDi>B-05060116920604</basicUdiDi>
    <tradeName>05060116920604</tradeName>
    <deviceName>TheraSphere Yttrium-90 Glass Microspheres</deviceName>
    <manufacturerName>Biocompatibles UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000052971</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OTT-SPE-FP-700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:51:11.631Z</lastUpdated>
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    <udiDi>05060116920598</udiDi>
    <basicUdiDi>B-05060116920598</basicUdiDi>
    <tradeName>05060116920598</tradeName>
    <deviceName>TheraSphere Yttrium-90 Glass Microspheres</deviceName>
    <manufacturerName>Biocompatibles UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000052971</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OTT-SPE-FP-700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:51:10.838Z</lastUpdated>
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