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    <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>
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    <legislation>MDD</legislation>
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    <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>
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    <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>
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    <tradeName>09342451006554</tradeName>
    <deviceName>Somfit Pro System</deviceName>
    <manufacturerName>Compumedics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000050437</manufacturerSrn>
    <authorisedRepresentativeName>Compumedics EUROPE GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <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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    <udiDi>09342451002761</udiDi>
    <basicUdiDi>B-09342451002761</basicUdiDi>
    <tradeName>09342451002761</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>9037-0002-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:40:59.421Z</lastUpdated>
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    <udiDi>09342451001368</udiDi>
    <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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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <tradeName>08720256698074</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <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>
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    <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>
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    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <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>
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    <tradeName>08720256698043</tradeName>
    <deviceName>Onera STS I</deviceName>
    <manufacturerName>Onera B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000023811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <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>
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