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    <tradeName>SOMNO HD eco</tradeName>
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    <manufacturerName>SOMNOmedics AG</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <reference>NGN050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:47:40.562Z</lastUpdated>
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    <tradeName>MediByte Jr</tradeName>
    <deviceName>MediByte</deviceName>
    <manufacturerName>BRAEBON Medical Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000002190</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>04251978600037</udiDi>
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    <tradeName>Sonata Neuro Module</tradeName>
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    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <reference>930020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:34:36.929Z</lastUpdated>
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    <basicUdiDi>42519786020052C</basicUdiDi>
    <tradeName>Sonata Patient Recorder</tradeName>
    <deviceName>Polysomnographgerät</deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>930010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:11:07.506Z</lastUpdated>
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    <udiDi>00382830025928</udiDi>
    <basicUdiDi>038283NA00109EA</basicUdiDi>
    <tradeName>XactTrace Lock - Abdomen</tradeName>
    <deviceName>XactTrace® Single Use Respiratory Effort Belt System</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>1421020</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:24:42.670Z</lastUpdated>
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    <udiDi>00382830000222</udiDi>
    <basicUdiDi>0382830059206TX</basicUdiDi>
    <tradeName>Reusable Stackable Jumper Linker Cable</tradeName>
    <deviceName>Natus Ancillary Cables</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>102108</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:23:51.890Z</lastUpdated>
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    <udiDi>B140MBJRK0</udiDi>
    <basicUdiDi>++B140MBKITWM</basicUdiDi>
    <tradeName>MediByte Jr Kit</tradeName>
    <deviceName>MediByte Kit</deviceName>
    <manufacturerName>BRAEBON Medical Corporation</manufacturerName>
    <manufacturerSrn>CA-PR-000013743</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBJRK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:52:30.555Z</lastUpdated>
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    <udiDi>15694311111603</udiDi>
    <basicUdiDi>B-15694311111603</basicUdiDi>
    <tradeName>C1s Kit EU</tradeName>
    <deviceName>Nox C1s Kit</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>544023</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:28.017Z</lastUpdated>
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    <udiDi>15694311111559</udiDi>
    <basicUdiDi>B-15694311111559</basicUdiDi>
    <tradeName>A1s Recorder</tradeName>
    <deviceName>A1s Recorder</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>561411</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:27.215Z</lastUpdated>
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    <udiDi>15694311111436</udiDi>
    <basicUdiDi>B-15694311111436</basicUdiDi>
    <tradeName>T3s Recorder EU</tradeName>
    <deviceName>T3s Recorder EU</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>561011</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:26.423Z</lastUpdated>
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    <udiDi>15694311111146</udiDi>
    <basicUdiDi>B-15694311111146</basicUdiDi>
    <tradeName>Nox C1 Kit</tradeName>
    <deviceName>Nox C1 Kit</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>544020</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:21.621Z</lastUpdated>
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  <row>
    <udiDi>15694311110590</udiDi>
    <basicUdiDi>B-15694311110590</basicUdiDi>
    <tradeName>Nox C1 Access Point</tradeName>
    <deviceName>Nox C1 Access Point</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NOX-SCOM1</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:20.821Z</lastUpdated>
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    <udiDi>09342451007001</udiDi>
    <basicUdiDi>B-09342451007001</basicUdiDi>
    <tradeName>09342451007001</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>9028-0002-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:41:17.834Z</lastUpdated>
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    <udiDi>09342451006776</udiDi>
    <basicUdiDi>B-09342451006776</basicUdiDi>
    <tradeName>09342451006776</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>9028-0020-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:41:17.028Z</lastUpdated>
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    <udiDi>09342451006592</udiDi>
    <basicUdiDi>B-09342451006592</basicUdiDi>
    <tradeName>09342451006592</tradeName>
    <deviceName>Somfit Pro System</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>9037-0020-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:41:12.227Z</lastUpdated>
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    <udiDi>09342451006554</udiDi>
    <basicUdiDi>B-09342451006554</basicUdiDi>
    <tradeName>09342451006554</tradeName>
    <deviceName>Somfit Pro System</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>9037-0016-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:41:11.429Z</lastUpdated>
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    <udiDi>09342451002853</udiDi>
    <basicUdiDi>B-09342451002853</basicUdiDi>
    <tradeName>09342451002853</tradeName>
    <deviceName>Somfit System</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>9037-0012-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:41:04.221Z</lastUpdated>
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    <udiDi>09342451002785</udiDi>
    <basicUdiDi>B-09342451002785</basicUdiDi>
    <tradeName>09342451002785</tradeName>
    <deviceName>Falcon HST</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>9036-0001-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:41:00.242Z</lastUpdated>
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    <tradeName>09342451002761</tradeName>
    <deviceName>Somfit System</deviceName>
    <manufacturerName>Compumedics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000050437</manufacturerSrn>
    <authorisedRepresentativeName>Compumedics EUROPE GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:40:59.421Z</lastUpdated>
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    <basicUdiDi>B-09342451001368</basicUdiDi>
    <tradeName>09342451001368</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9023-0002-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:40:52.209Z</lastUpdated>
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