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    <tradeName>LATITUDE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
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    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
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    <emdnDescription>PACEMAKER AND IMPLANTABLE DEFIBRILLATOR REMOTE MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
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    <tradeName>LATITUDE™</tradeName>
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    <emdnDescription>PACEMAKER AND IMPLANTABLE DEFIBRILLATOR REMOTE MONITORING SYSTEMS</emdnDescription>
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    <tradeName>LATITUDE™</tradeName>
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    <tradeName>LATITUDE™</tradeName>
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    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
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    <udiDi>00802526625770</udiDi>
    <basicUdiDi>01915060000000000000148MZ</basicUdiDi>
    <tradeName>LATITUDE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
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    <emdnDescription>PACEMAKER AND IMPLANTABLE DEFIBRILLATOR REMOTE MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>D-2112095166</udiDi>
    <basicUdiDi>B-2112095166</basicUdiDi>
    <tradeName>Atrostim PNS</tradeName>
    <deviceName>Atrostim Phrenic Nerve Stimulator</deviceName>
    <manufacturerName>Atrotech Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000015061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>na</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:27:24.812Z</lastUpdated>
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    <udiDi>10810005340318</udiDi>
    <basicUdiDi>B-10810005340318</basicUdiDi>
    <tradeName>Axonics Accessory Tunneling Tool and Directional Guide</tradeName>
    <deviceName>Axonics Accessory Tunneling Tool and Directional Guide</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:47.776Z</lastUpdated>
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    <udiDi>10810005340301</udiDi>
    <basicUdiDi>B-10810005340301</basicUdiDi>
    <tradeName>Axonics Accessory Dilator and Sheath</tradeName>
    <deviceName>Axonics Accessory Dilator and Sheath</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:46.968Z</lastUpdated>
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    <basicUdiDi>B-10810005340462</basicUdiDi>
    <tradeName>Axonics Accessory Tunneling Tool</tradeName>
    <deviceName>Axonics Accessory Tunneling Tool</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
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    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:45.378Z</lastUpdated>
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    <udiDi>10810005340325</udiDi>
    <basicUdiDi>B-10810005340325</basicUdiDi>
    <tradeName>Axonics Accessory, Basic Trial Cable</tradeName>
    <deviceName>Axonics Accessory, Basic Trial Cable</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
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    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:44.680Z</lastUpdated>
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    <udiDi>10810005340288</udiDi>
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    <tradeName>Axonics Accessory, Lead Extension Cable</tradeName>
    <deviceName>Axonics Accessory, Lead Extension Cable</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:27.715Z</lastUpdated>
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    <udiDi>10810005340271</udiDi>
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    <tradeName>Axonics Accessory, Charging Belt - Extended Size</tradeName>
    <deviceName>Axonics Accessory, Charging Belt - Extended Size</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
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    <reference>9008-E</reference>
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    <lastUpdated>2026-07-11T00:15:26.921Z</lastUpdated>
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    <udiDi>10810005340264</udiDi>
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    <tradeName>Axonics Accessory, Charging Belt - Regular Size</tradeName>
    <deviceName>Axonics Accessory, Charging Belt - Regular Size</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <tradeName>Axonics Accessory, Lead Stimulation Cable</tradeName>
    <deviceName>Axonics Accessory, Lead Stimulation Cable</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
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    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:25.419Z</lastUpdated>
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    <tradeName>Axonics Accessory, J-Clip Stimulation Cable</tradeName>
    <deviceName>Axonics Accessory, J-Clip Stimulation Cable</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:21.878Z</lastUpdated>
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    <udiDi>10810005340233</udiDi>
    <basicUdiDi>B-10810005340233</basicUdiDi>
    <tradeName>Axonics Accessory, Charging System Adhesive Carriers</tradeName>
    <deviceName>Axonics Accessory, Charging System Adhesive Carriers</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:20.515Z</lastUpdated>
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