<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850298007157</udiDi>
    <basicUdiDi>0850298007159C</basicUdiDi>
    <tradeName>00850298007157</tradeName>
    <deviceName>Steel Electrode, Cupped</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009421</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100380</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EECU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:29.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850298007058</udiDi>
    <basicUdiDi>08502980070599</basicUdiDi>
    <tradeName>00850298007058</tradeName>
    <deviceName>Mouth Protector (EMGS)</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009421</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100385</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EMGS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:09.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008393259</udiDi>
    <basicUdiDi>0850008393SI1842Q8</basicUdiDi>
    <tradeName>BWMini HST Compass</tradeName>
    <deviceName>BWMini HST Compass</deviceName>
    <manufacturerName>Neurovirtual USA Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042555</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100303</emdnCode>
    <emdnDescription>SYSTEMS FOR ANALYSING AND MANAGING EEG TRACES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI1842</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:09:44.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008393242</udiDi>
    <basicUdiDi>0850008393PV2312SM</basicUdiDi>
    <tradeName>BWMini HST</tradeName>
    <deviceName>BWMini HST</deviceName>
    <manufacturerName>Neurovirtual USA Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042555</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100303</emdnCode>
    <emdnDescription>SYSTEMS FOR ANALYSING AND MANAGING EEG TRACES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PV2312</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:09:43.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008393235</udiDi>
    <basicUdiDi>0850008393PV2310SH</basicUdiDi>
    <tradeName>BWMini EEG</tradeName>
    <deviceName>BWMini EEG</deviceName>
    <manufacturerName>Neurovirtual USA Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042555</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100303</emdnCode>
    <emdnDescription>SYSTEMS FOR ANALYSING AND MANAGING EEG TRACES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PV2310</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:09:43.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008393228</udiDi>
    <basicUdiDi>0850008393PV2311SK</basicUdiDi>
    <tradeName>BWMini PSG</tradeName>
    <deviceName>BWMini PSG</deviceName>
    <manufacturerName>Neurovirtual USA Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042555</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100303</emdnCode>
    <emdnDescription>SYSTEMS FOR ANALYSING AND MANAGING EEG TRACES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PV2311</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:09:39.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008393204</udiDi>
    <basicUdiDi>0850008393BWIIIPSGSU</basicUdiDi>
    <tradeName>BWIII PSG</tradeName>
    <deviceName>BWIII PSG</deviceName>
    <manufacturerName>Neurovirtual USA Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042555</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100303</emdnCode>
    <emdnDescription>SYSTEMS FOR ANALYSING AND MANAGING EEG TRACES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PV2008</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:09:38.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008393174</udiDi>
    <basicUdiDi>0850008393BWIIIEEGPT</basicUdiDi>
    <tradeName>BWIII Basics</tradeName>
    <deviceName>BWIII EEG</deviceName>
    <manufacturerName>Neurovirtual USA Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042555</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100303</emdnCode>
    <emdnDescription>SYSTEMS FOR ANALYSING AND MANAGING EEG TRACES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PV2010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:09:38.849Z</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>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>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>00382830059305</udiDi>
    <basicUdiDi>038283NA00058EJ</basicUdiDi>
    <tradeName>Quantum Breakout Roll stand</tradeName>
    <deviceName>Quantum II Class I 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>017264</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:26:38.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830058209</udiDi>
    <basicUdiDi>0382830059190U9</basicUdiDi>
    <tradeName>IP Alarm Controller Box</tradeName>
    <deviceName>Natus Alarm Relay Controller</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>022979</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:26:32.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830048460</udiDi>
    <basicUdiDi>038283NA00092EJ</basicUdiDi>
    <tradeName>EMU40EX with new Natus Base</tradeName>
    <deviceName>EMU40EX</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>Z12100302</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PK1072-NTB-9</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:25:48.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830047234</udiDi>
    <basicUdiDi>038283NA00153ED</basicUdiDi>
    <tradeName>Natus Brain Monitor and Embla Dx</tradeName>
    <deviceName>Natus Brain Monitor Kit</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>Z12100302</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>021919</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:25:26.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830043809</udiDi>
    <basicUdiDi>038283NA00086EP</basicUdiDi>
    <tradeName>00382830043809</tradeName>
    <deviceName>Nicolet EEG Patient Event Button</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>Z12100380</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>085-462401</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:25:08.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830043779</udiDi>
    <basicUdiDi>038283NA00094EN</basicUdiDi>
    <tradeName>Trex HD Headbox Monitoring</tradeName>
    <deviceName>Trex Ext. Battery Cable</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>Z12100302</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>019245</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:25:03.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830016780</udiDi>
    <basicUdiDi>038283NA00057EG</basicUdiDi>
    <tradeName>Natus Quantum 10-10/10-20 Pin Box</tradeName>
    <deviceName>Quantum II Class I 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>017048</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:24:22.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830016476</udiDi>
    <basicUdiDi>038283NA00055EC</basicUdiDi>
    <tradeName>Natus Quantum Patient Event Button 30 ft. (1.5 m)</tradeName>
    <deviceName>Quantum II Class I 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>Z12100302</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>013891</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:24:22.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830016346</udiDi>
    <basicUdiDi>038283NA00152EB</basicUdiDi>
    <tradeName>Natus Quantum</tradeName>
    <deviceName>Quantum (Phase II) 64-channel Breakout</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>Z12100302</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>014162</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:24:04.893Z</lastUpdated>
  </row>
</eudamedExport>