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    <tradeName>SMARTFrame Accessory Kit, 4 Fr - Europe</tradeName>
    <deviceName>SMARTFrame Accessory Kit, 4 Fr - Europe</deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-AK-01-11-4-E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:23.089Z</lastUpdated>
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    <udiDi>04056481005177</udiDi>
    <basicUdiDi>4056481DisposableStyletAC</basicUdiDi>
    <tradeName>Disposable stylet</tradeName>
    <deviceName>Disposable Stylet</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55793</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:29:24.768Z</lastUpdated>
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    <udiDi>00850376007765</udiDi>
    <basicUdiDi>0850376007688Q</basicUdiDi>
    <tradeName>SmartFrame XG, 5 Fr – Europe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-SF-02-11-5-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.344Z</lastUpdated>
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    <udiDi>00850376007772</udiDi>
    <basicUdiDi>0850376007798V</basicUdiDi>
    <tradeName>SmartFrame XG Exchangeable Device Guide, 2.5 mm – Europe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-XG-03-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.326Z</lastUpdated>
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    <udiDi>00850376007789</udiDi>
    <basicUdiDi>0850376007798V</basicUdiDi>
    <tradeName>SmartFrame XG Exchangeable Device Guide, 4.5 mm – Europe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-XG-02-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.314Z</lastUpdated>
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    <udiDi>00850376007796</udiDi>
    <basicUdiDi>0850376007798V</basicUdiDi>
    <tradeName>SmartFrame XG Exchangeable Device Guides – Europe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-XG-01-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.298Z</lastUpdated>
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    <udiDi>00850376007819</udiDi>
    <basicUdiDi>0850376007808E</basicUdiDi>
    <tradeName>MR Neuro Drape Tapered w/Extension (GE)-Long</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-PD-03-L-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.267Z</lastUpdated>
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    <udiDi>00850376007826</udiDi>
    <basicUdiDi>0850376007808E</basicUdiDi>
    <tradeName>MR Bore Drape w/Extension (IMRIS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-PD-04-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.250Z</lastUpdated>
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    <udiDi>00850376007833</udiDi>
    <basicUdiDi>0850376007808E</basicUdiDi>
    <tradeName>MR  Patient Drape (IMRIS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-PD-05-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.233Z</lastUpdated>
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