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    <tradeName>EpiMonitor by Empatica</tradeName>
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    <manufacturerName>Empatica S.r.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000012905</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>NERVOUS SYSTEM MONITORING SYSTEMS</emdnDescription>
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    <reference>EpiMonitor-IOS</reference>
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    <lastUpdated>2026-07-16T03:39:47.038Z</lastUpdated>
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    <basicUdiDi>0851113007PS34PZ</basicUdiDi>
    <tradeName>PoSAS</tradeName>
    <deviceName>Positional Sleep Assessment System (PoSAS) Software</deviceName>
    <manufacturerName>Advanced Brain Monitoring, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011252</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
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    <reference>PS34-5401</reference>
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    <basicUdiDi>0850376007848N</basicUdiDi>
    <tradeName>SmartFrame XG Targeting Cannula</tradeName>
    <deviceName>SmartFrame XG Targeting Cannula</deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <basicUdiDi>0850376007808E</basicUdiDi>
    <tradeName>MR Neuro Drape Tapered (Siemens/Philips)-Long</tradeName>
    <deviceName>MR Drape</deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-PD-02-L-E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:03.492Z</lastUpdated>
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    <basicUdiDi>0850376007698S</basicUdiDi>
    <tradeName>SmartFrame Scalp Mount Base – Europe</tradeName>
    <deviceName>SmartFrame Scalp Mount Base – Europe</deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-SM-01-E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:01.894Z</lastUpdated>
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    <udiDi>00850376007680</udiDi>
    <basicUdiDi>0850376007688Q</basicUdiDi>
    <tradeName>SmartFrame XG – Europe</tradeName>
    <deviceName>SmartFrame XG, 5 Fr – Europe</deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-SF-02-11-E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:01.090Z</lastUpdated>
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    <basicUdiDi>0850376007798V</basicUdiDi>
    <tradeName>SmartFrame XG Exchangeable Device Guide, 5.4-mm</tradeName>
    <deviceName>SmartFrame XG Exchangeable Device Guides – Europe</deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-XG-06</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:59.486Z</lastUpdated>
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    <udiDi>00850376007482</udiDi>
    <basicUdiDi>0850376007488J</basicUdiDi>
    <tradeName>Inflexion Avanto HFF</tradeName>
    <deviceName>ClearPoint Inflexion</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>Z12100680</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-INHFF-112-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:57.088Z</lastUpdated>
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    <udiDi>00850376007376</udiDi>
    <basicUdiDi>0850376007378D</basicUdiDi>
    <tradeName>ClearPoint Multi-Positional Upper Fixation Frame Screws</tradeName>
    <deviceName>ClearPoint Multi-Positional HFF Screws</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>Z12100680</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-FFSMPU-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:55.478Z</lastUpdated>
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    <udiDi>00850376007000</udiDi>
    <basicUdiDi>08503760072484</basicUdiDi>
    <tradeName>ClearPoint Siemens Sola / Vida Multi-Positional HFF</tradeName>
    <deviceName>ClearPoint Multi-Positional HFF</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>Z12100680</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-MPHFF-132-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:54.774Z</lastUpdated>
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    <udiDi>00850359007348</udiDi>
    <basicUdiDi>0850359007348C</basicUdiDi>
    <tradeName>SmartTwist MR Hand Drill</tradeName>
    <deviceName>SmartTwist MR Hand Drill</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>Z12100902</emdnCode>
    <emdnDescription>DRILLS FOR NEUROSURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-HD-01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:53.088Z</lastUpdated>
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    <udiDi>00850359007232</udiDi>
    <basicUdiDi>08503590072387</basicUdiDi>
    <tradeName>SmartFrame Guide Tubes (Set)</tradeName>
    <deviceName>SmartFrame Guide Tubes (Set)</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>
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    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-GT-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:50.679Z</lastUpdated>
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    <udiDi>00850359007171</udiDi>
    <basicUdiDi>0850359007178C</basicUdiDi>
    <tradeName>SmartFrame Thumb Wheel Extension Set</tradeName>
    <deviceName>SmartFrame Thumb Wheel Extension Set</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>
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    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-TE-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:49.078Z</lastUpdated>
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    <udiDi>00850359007140</udiDi>
    <basicUdiDi>08503590071486</basicUdiDi>
    <tradeName>SmartGrid Planning Grid</tradeName>
    <deviceName>SmartGrid Planning Grid</deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-SG-01-11</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:48.276Z</lastUpdated>
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    <basicUdiDi>08502980072197</basicUdiDi>
    <tradeName>00850298007218</tradeName>
    <deviceName>Monitoring Cable, Gray System IV</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009421</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECEF-4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:37.871Z</lastUpdated>
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    <udiDi>00850298007201</udiDi>
    <basicUdiDi>08502980072095</basicUdiDi>
    <tradeName>ECT Treatment Cable</tradeName>
    <deviceName>ECT Treatment Cable/Bk</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECET-P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:36.279Z</lastUpdated>
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    <basicUdiDi>0850298007189J</basicUdiDi>
    <tradeName>00850298007188</tradeName>
    <deviceName>Insulated Handle</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>EHAN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:33.873Z</lastUpdated>
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    <deviceName>Remote Treatment Handle</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
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    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
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    <reference>ERTH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:31.467Z</lastUpdated>
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    <deviceName>Steel Electrode, Cupped</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EECU</reference>
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    <lastUpdated>2026-07-16T03:32:29.068Z</lastUpdated>
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    <deviceName>Mouth Protector (EMGS)</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
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    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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