<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00811852030318</udiDi>
    <basicUdiDi>081185203VIZICHBG</basicUdiDi>
    <tradeName>Viz ICH</tradeName>
    <deviceName>Viz ICH</deviceName>
    <manufacturerName>Viz.ai</manufacturerName>
    <manufacturerSrn>US-MF-000024837</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109082</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081185203VIZICHBG</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:21.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811852030301</udiDi>
    <basicUdiDi>081185203VIZLVOE6</basicUdiDi>
    <tradeName>Viz LVO</tradeName>
    <deviceName>Viz LVO</deviceName>
    <manufacturerName>Viz.ai</manufacturerName>
    <manufacturerSrn>US-MF-000024837</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109082</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081185203VIZLVOE6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:21.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811852030288</udiDi>
    <basicUdiDi>081185203VIZCTPCM</basicUdiDi>
    <tradeName>Viz CTP</tradeName>
    <deviceName>Viz CTP</deviceName>
    <manufacturerName>Viz.ai</manufacturerName>
    <manufacturerSrn>US-MF-000024837</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109082</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081185203VIZCTPCM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:17.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810155860035</udiDi>
    <basicUdiDi>081015586NERVEANAPLUSXZ</basicUdiDi>
    <tradeName>Neurovision Medical Products Inc.</tradeName>
    <deviceName>Nerveana Plus</deviceName>
    <manufacturerName>Neurovision Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100401</emdnCode>
    <emdnDescription>ELECTROMYOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVP-S-T</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:56:45.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056446900642</udiDi>
    <basicUdiDi>080564469MDSW_EK</basicUdiDi>
    <tradeName>Galileo NExT</tradeName>
    <deviceName>MDSW Family</deviceName>
    <manufacturerName>EB Neuro S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000027944</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109092</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B8640053000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:32:39.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056446900000</udiDi>
    <basicUdiDi>080564469EEG_BE</basicUdiDi>
    <tradeName>BE Micro</tradeName>
    <deviceName>EEG Family</deviceName>
    <manufacturerName>EB Neuro S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000027944</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B9800073000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:32:38.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056446900208</udiDi>
    <basicUdiDi>080564469EMG_CN</basicUdiDi>
    <tradeName>NeMus</tradeName>
    <deviceName>EMG Family</deviceName>
    <manufacturerName>EB Neuro S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000027944</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100401</emdnCode>
    <emdnDescription>ELECTROMYOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B9800066600</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:32:34.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000843915</udiDi>
    <basicUdiDi>0763000B00025127U</basicUdiDi>
    <tradeName>00763000843915</tradeName>
    <deviceName>Nerve Monitoring Patient Interface</deviceName>
    <manufacturerName>Medtronic Xomed Inc</manufacturerName>
    <manufacturerSrn>US-MF-000023264</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121002</emdnCode>
    <emdnDescription>NERVOUS SYSTEM MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIM4CPB1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:08:20.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000843908</udiDi>
    <basicUdiDi>0763000B000247187</basicUdiDi>
    <tradeName>00763000843908</tradeName>
    <deviceName>Nerve Monitoring Equipment</deviceName>
    <manufacturerName>Medtronic Xomed Inc</manufacturerName>
    <manufacturerSrn>US-MF-000023264</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121002</emdnCode>
    <emdnDescription>NERVOUS SYSTEM MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIM4CM01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:08:19.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340201503676</udiDi>
    <basicUdiDi>073402015BUDI000000019PS</basicUdiDi>
    <tradeName>Leksell Vantage X-Ray Fiducial Box</tradeName>
    <deviceName>Leksell Vantage Stereotactic System</deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002125</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100601</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1136431</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:01:46.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340201501269</udiDi>
    <basicUdiDi>073400483BUDI000000002ZS</basicUdiDi>
    <tradeName>FirmFix 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002125</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100601</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1040031</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:01:45.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>00607411000980</udiDi>
    <basicUdiDi>0607411TF20010_SleepDx9V</basicUdiDi>
    <tradeName>Filter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Salter Labs</manufacturerName>
    <manufacturerSrn>US-MF-000007934</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-0-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:52:51.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049098008013</udiDi>
    <basicUdiDi>0404867521070256K19Z320ST</basicUdiDi>
    <tradeName>EEG-ABL. 0,6M, MEHRWEG, 9STK.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Draeger Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020721</manufacturerSrn>
    <authorisedRepresentativeName>Drägerwerk AG &amp; Co. KGaA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005330</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100380</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5947804</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:59:47.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780521327</udiDi>
    <basicUdiDi>038178B0076CSS4R</basicUdiDi>
    <tradeName>CODMAN CERTAS®</tradeName>
    <deviceName>ICP Programmer</deviceName>
    <manufacturerName>Integra LifeSciences Production Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000009189</manufacturerSrn>
    <authorisedRepresentativeName>Integra LifeSciences Services</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000002474</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109003</emdnCode>
    <emdnDescription>CEREBROSPINAL FLUID PRESSURE MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82-8851</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:29:25.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830059923</udiDi>
    <basicUdiDi>038283NA00090EE</basicUdiDi>
    <tradeName>FHD IP PTZ Wall Mounted Camera Kit, INTL</tradeName>
    <deviceName>Wall Mount Accessories</deviceName>
    <manufacturerName>NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK)</manufacturerName>
    <manufacturerSrn>CA-MF-000004001</manufacturerSrn>
    <authorisedRepresentativeName>Natus Manufacturing Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000884</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100380</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>022664</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:26:50.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830059909</udiDi>
    <basicUdiDi>038283NA00085EM</basicUdiDi>
    <tradeName>00382830059909</tradeName>
    <deviceName>UltraPro UB3 Cart</deviceName>
    <manufacturerName>Natus Neurology Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000004246</manufacturerSrn>
    <authorisedRepresentativeName>Natus Manufacturing Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000884</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100401</emdnCode>
    <emdnDescription>ELECTROMYOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>048778</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:26:46.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830059534</udiDi>
    <basicUdiDi>038283NA00053E8</basicUdiDi>
    <tradeName>NeuroWorks / SleepWorks Software</tradeName>
    <deviceName>NeuroWorks/SleepWorks 9.3.0 Installation Media (INTL)</deviceName>
    <manufacturerName>NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK)</manufacturerName>
    <manufacturerSrn>CA-MF-000004001</manufacturerSrn>
    <authorisedRepresentativeName>Natus Manufacturing Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000884</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100392</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034877</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:26:45.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830059442</udiDi>
    <basicUdiDi>038283NA00049EH</basicUdiDi>
    <tradeName>00382830059442</tradeName>
    <deviceName>UB4 Cart</deviceName>
    <manufacturerName>Natus Neurology Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000004246</manufacturerSrn>
    <authorisedRepresentativeName>Natus Manufacturing Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000884</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100480</emdnCode>
    <emdnDescription>ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>842-690100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:26:44.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830059381</udiDi>
    <basicUdiDi>038283NA00046EB</basicUdiDi>
    <tradeName>00382830059381</tradeName>
    <deviceName>Nicolet EDX Amplifier Cables</deviceName>
    <manufacturerName>Natus Neurology Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000004246</manufacturerSrn>
    <authorisedRepresentativeName>Natus Manufacturing Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000884</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100480</emdnCode>
    <emdnDescription>ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>085-478900</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:26:44.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830059343</udiDi>
    <basicUdiDi>038283NA00050E2</basicUdiDi>
    <tradeName>00382830059343</tradeName>
    <deviceName>UB4 Cart Grounding Kit</deviceName>
    <manufacturerName>Natus Neurology Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000004246</manufacturerSrn>
    <authorisedRepresentativeName>Natus Manufacturing Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000884</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100480</emdnCode>
    <emdnDescription>ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>698-633700</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:26:40.128Z</lastUpdated>
  </row>
</eudamedExport>