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<eudamedExport entity="devices">
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    <udiDi>00850376007741</udiDi>
    <basicUdiDi>B-00850376007741</basicUdiDi>
    <tradeName>SMARTFrame Accessory Kit, 7 Fr - Europe</tradeName>
    <deviceName>SMARTFrame Accessory Kit, 7 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-01-11-7-E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:24.694Z</lastUpdated>
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  <row>
    <udiDi>00850359007522</udiDi>
    <basicUdiDi>B-00850359007522</basicUdiDi>
    <tradeName>SMARTFrame Accessory Kit, 5 Fr - Europe</tradeName>
    <deviceName>SMARTFrame Accessory Kit, 5 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-01-11-5-E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:23.888Z</lastUpdated>
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  <row>
    <udiDi>00850359007515</udiDi>
    <basicUdiDi>B-00850359007515</basicUdiDi>
    <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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  <row>
    <udiDi>00850359007140</udiDi>
    <basicUdiDi>08503590071486</basicUdiDi>
    <tradeName>SmartGrid Planning Grid</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>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-SG-01-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.766Z</lastUpdated>
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  <row>
    <udiDi>00850359007171</udiDi>
    <basicUdiDi>0850359007178C</basicUdiDi>
    <tradeName>SmartFrame Thumb Wheel Extension Set</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-TE-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.754Z</lastUpdated>
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  <row>
    <udiDi>00850359007232</udiDi>
    <basicUdiDi>08503590072387</basicUdiDi>
    <tradeName>SmartFrame Guide Tubes (Set)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-GT-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.742Z</lastUpdated>
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    <udiDi>00850359007348</udiDi>
    <basicUdiDi>0850359007348C</basicUdiDi>
    <tradeName>SmartTwist MR Hand Drill</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRILLS FOR NEUROSURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS-HD-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850376007000</udiDi>
    <basicUdiDi>08503760072484</basicUdiDi>
    <tradeName>ClearPoint Siemens Sola / Vida Multi-Positional HFF</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-MPHFF-132-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.714Z</lastUpdated>
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  <row>
    <udiDi>00850376007246</udiDi>
    <basicUdiDi>08503760072484</basicUdiDi>
    <tradeName>ClearPoint SMS Avanto Table Multi-Positional HFF</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-MPHFF-112-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.704Z</lastUpdated>
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  <row>
    <udiDi>00850376007253</udiDi>
    <basicUdiDi>08503760072484</basicUdiDi>
    <tradeName>ClearPoint Siemens Aera / Skyra Multi-Positional HFF</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-MPHFF-122-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850376007260</udiDi>
    <basicUdiDi>08503760072484</basicUdiDi>
    <tradeName>ClearPoint IMRIS with Base Multi-Positional HFF</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-MPHFF-211-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850376007291</udiDi>
    <basicUdiDi>08503760072484</basicUdiDi>
    <tradeName>ClearPoint GE HDx Table Multi-Positional HFF</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-MPHFF-312-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850376007307</udiDi>
    <basicUdiDi>08503760072484</basicUdiDi>
    <tradeName>ClearPoint GE HDw (450w) Table Multi-Positional HFF</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-MPHFF-322-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.655Z</lastUpdated>
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  <row>
    <udiDi>00850376007314</udiDi>
    <basicUdiDi>08503760072484</basicUdiDi>
    <tradeName>ClearPoint GE 750w Table Multi-Positional HFF</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-MPHFF-332-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850376007321</udiDi>
    <basicUdiDi>08503760072484</basicUdiDi>
    <tradeName>ClearPoint Philips Achieva Table Multi-Positional HFF</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-MPHFF-412-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.635Z</lastUpdated>
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  <row>
    <udiDi>00850376007338</udiDi>
    <basicUdiDi>08503760072484</basicUdiDi>
    <tradeName>ClearPoint Philips Igenia Table Multi-Positional HFF</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-MPHFF-422-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.622Z</lastUpdated>
  </row>
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    <udiDi>00850376007376</udiDi>
    <basicUdiDi>0850376007378D</basicUdiDi>
    <tradeName>ClearPoint Multi-Positional Upper Fixation Frame Screws</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-FFSMPU-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.611Z</lastUpdated>
  </row>
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    <udiDi>00850376007383</udiDi>
    <basicUdiDi>0850376007378D</basicUdiDi>
    <tradeName>ClearPoint Multi-Positional Lower HFF Screws for GE, Siemens and 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-FFSMPL-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.600Z</lastUpdated>
  </row>
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    <udiDi>00850376007420</udiDi>
    <basicUdiDi>08503760072484</basicUdiDi>
    <tradeName>ClearPoint IMRIS Universal Multi-Positional HFF</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-MPHFF-232-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.587Z</lastUpdated>
  </row>
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    <udiDi>00850376007468</udiDi>
    <basicUdiDi>08503760072484</basicUdiDi>
    <tradeName>ClearPoint IMRIS Aera / Skyra Multi-Positional HFF</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-MPHFF-242-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:41.572Z</lastUpdated>
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