<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00805832070081</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName>Passive Reflective Markers</deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8801085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:46:23.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>00805832070074</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName>Passive Reflective Markers</deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8801075</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:43:27.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>00805832070067</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName>Passive Reflective Markers</deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8801074</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:34:46.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>00805832070050</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName>Passive Reflective Markers</deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8801071</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:12:40.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481141141</udiDi>
    <basicUdiDi>4056481Suction9A</basicUdiDi>
    <tradeName>Disposable Precalibrated Suction</tradeName>
    <deviceName>Disposable Precalibrated Suction</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>52185-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:33:49.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>00873263009314</udiDi>
    <basicUdiDi>087326300.12-100-1-A.TD</basicUdiDi>
    <tradeName>Visualase™ Neuro Accessories and Tools</tradeName>
    <deviceName>Visualase Neuro Accessories</deviceName>
    <manufacturerName>FHC Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012111</manufacturerSrn>
    <authorisedRepresentativeName>TERMOBIT PROD SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>RO-AR-000010668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9736536</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:01:25.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>00873263009406</udiDi>
    <basicUdiDi>087326300.12-101-1-A.TS</basicUdiDi>
    <tradeName>Visualase™ Neuro Accessories and Tools</tradeName>
    <deviceName>Visualase Anchor Bolt Tools, Sterile</deviceName>
    <manufacturerName>FHC Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012111</manufacturerSrn>
    <authorisedRepresentativeName>TERMOBIT PROD SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>RO-AR-000010668</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9736545</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:01:24.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850376007840</udiDi>
    <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>
    <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-TC-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:05.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850376007802</udiDi>
    <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>
    <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-02-L-E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:03.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850376007697</udiDi>
    <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>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <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>
  </row>
  <row>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <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>
  </row>
  <row>
    <udiDi>00850376007666</udiDi>
    <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>
    <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-06</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:59.486Z</lastUpdated>
  </row>
  <row>
    <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>
    <legislation>MDR 2017/745</legislation>
    <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>
  </row>
  <row>
    <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>
    <emdnCode>Z12100685</emdnCode>
    <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>
  </row>
  <row>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <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>
  </row>
  <row>
    <udiDi>00850047354082</udiDi>
    <basicUdiDi>0850047354086U</basicUdiDi>
    <tradeName>Depth Stop, 6 Pack</tradeName>
    <deviceName>Depth Stop, 6 Pack</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-DS-06</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:29:46.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>00873263009338</udiDi>
    <basicUdiDi>087326300.12-100-1-A.TD</basicUdiDi>
    <tradeName>Visualase™ Neuro Accessories and Tools</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FHC Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012111</manufacturerSrn>
    <authorisedRepresentativeName>TERMOBIT PROD SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>RO-AR-000010668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100685</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9736538</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:28:02.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481141165</udiDi>
    <basicUdiDi>4056481Suction9A</basicUdiDi>
    <tradeName>DISPOSABLE PRE-CALIBRATED SUCTION CHARR. 8 (1 PC)</tradeName>
    <deviceName></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>52184-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:49:02.287Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <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>
  </row>
</eudamedExport>