<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09342451001313</udiDi>
    <basicUdiDi>B-09342451001313</basicUdiDi>
    <tradeName>09342451001313</tradeName>
    <deviceName>Grael</deviceName>
    <manufacturerName>Compumedics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000050437</manufacturerSrn>
    <authorisedRepresentativeName>Compumedics EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000039096</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9028-0009-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:40:51.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>09342451001276</udiDi>
    <basicUdiDi>B-09342451001276</basicUdiDi>
    <tradeName>09342451001276</tradeName>
    <deviceName>Grael</deviceName>
    <manufacturerName>Compumedics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000050437</manufacturerSrn>
    <authorisedRepresentativeName>Compumedics EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000039096</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9028-0001-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:40:46.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698197</udiDi>
    <basicUdiDi>B-08720256698197</basicUdiDi>
    <tradeName>08720256698197</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS I STATION APPLICATION</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:24.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698173</udiDi>
    <basicUdiDi>B-08720256698173</basicUdiDi>
    <tradeName>08720256698173</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS I FLOW ADHESIVE</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:23.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698159</udiDi>
    <basicUdiDi>B-08720256698159</basicUdiDi>
    <tradeName>08720256698159</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS I LEG ADHESIVE</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:22.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698135</udiDi>
    <basicUdiDi>B-08720256698135</basicUdiDi>
    <tradeName>08720256698135</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS1 CHEST ADHESIVE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:20.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698111</udiDi>
    <basicUdiDi>B-08720256698111</basicUdiDi>
    <tradeName>08720256698111</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS I HEAD ADHESIVE A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:18.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698098</udiDi>
    <basicUdiDi>B-08720256698098</basicUdiDi>
    <tradeName>08720256698098</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS I HEAD ADHESIVE B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:16.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698074</udiDi>
    <basicUdiDi>B-08720256698074</basicUdiDi>
    <tradeName>08720256698074</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS I HEAD ADHESIVE C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:16.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698067</udiDi>
    <basicUdiDi>B-08720256698067</basicUdiDi>
    <tradeName>08720256698067</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS I FLOW CRADLE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:14.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698050</udiDi>
    <basicUdiDi>B-08720256698050</basicUdiDi>
    <tradeName>08720256698050</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS I FLOW</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:12.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698043</udiDi>
    <basicUdiDi>B-08720256698043</basicUdiDi>
    <tradeName>08720256698043</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS I CHEST/LEG CRADLE</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:10.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698036</udiDi>
    <basicUdiDi>B-08720256698036</basicUdiDi>
    <tradeName>08720256698036</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS I LEG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:09.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698029</udiDi>
    <basicUdiDi>B-08720256698029</basicUdiDi>
    <tradeName>08720256698029</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS I HEAD CRADLE</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:08.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698012</udiDi>
    <basicUdiDi>B-08720256698012</basicUdiDi>
    <tradeName>08720256698012</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS I CHEST</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:05.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256698005</udiDi>
    <basicUdiDi>B-08720256698005</basicUdiDi>
    <tradeName>08720256698005</tradeName>
    <deviceName>ONERA STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONERA STS I HEAD</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:14:04.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830000277</udiDi>
    <basicUdiDi>0382830059206TX</basicUdiDi>
    <tradeName>Reusable Shielded 3-in-1 Monopolar Extension Cable</tradeName>
    <deviceName></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>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W6179H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:47:31.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830025935</udiDi>
    <basicUdiDi>038283NA00109EA</basicUdiDi>
    <tradeName>XactTrace Lock Abdomen EBG</tradeName>
    <deviceName></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>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1421021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:47:28.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830025942</udiDi>
    <basicUdiDi>038283NA00109EA</basicUdiDi>
    <tradeName>XactTrace Lock - Thorax</tradeName>
    <deviceName></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>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1421022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:47:28.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382830026222</udiDi>
    <basicUdiDi>038283NA00109EA</basicUdiDi>
    <tradeName>XactTrace belt - Pediatric</tradeName>
    <deviceName></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>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011516</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:47:28.323Z</lastUpdated>
  </row>
</eudamedExport>