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    <tradeName>Monaco RTP System</tradeName>
    <deviceName>Monaco RTP System Software</deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
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    <reference>Monaco 6.3</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:40:41.354Z</lastUpdated>
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    <udiDi>04056481142131</udiDi>
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    <tradeName>RT Elements - Dose Review, 3.0</tradeName>
    <deviceName>RT Elements</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
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    <udiDi>04056481142124</udiDi>
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    <tradeName>RT Elements - RT QA, 3.0</tradeName>
    <deviceName>RT Elements</deviceName>
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    <tradeName>RT Elements - Spine SRS, 3.0</tradeName>
    <deviceName>RT Elements</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04056481142117</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:28:22.875Z</lastUpdated>
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    <udiDi>04056481142100</udiDi>
    <basicUdiDi>B-04056481142100</basicUdiDi>
    <tradeName>RT Elements - Cranial SRS, 3.0</tradeName>
    <deviceName>RT Elements</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11010492</emdnCode>
    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04056481142100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:28:21.274Z</lastUpdated>
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    <udiDi>04056481142094</udiDi>
    <basicUdiDi>B-04056481142094</basicUdiDi>
    <tradeName>RT Elements - Multiple Brain Mets SRS, 3.0</tradeName>
    <deviceName>RT Elements</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11010492</emdnCode>
    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04056481142094</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:28:18.872Z</lastUpdated>
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    <udiDi>04056481000530</udiDi>
    <basicUdiDi>B-04056481000530</basicUdiDi>
    <tradeName>RT Elements - Cranial SRS w/ Cones, 3.0</tradeName>
    <deviceName>RT Elements</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>04056481000530</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:24.374Z</lastUpdated>
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    <udiDi>06973127400074</udiDi>
    <basicUdiDi>697312740MRIALG</basicUdiDi>
    <tradeName>MRIA</tradeName>
    <deviceName>MRIA</deviceName>
    <manufacturerName>Manteia Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023911</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010492</emdnCode>
    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MR0074</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:40:27.004Z</lastUpdated>
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    <basicUdiDi>697312740AccuContourLTQ3</basicUdiDi>
    <tradeName>AccuContour-Lite</tradeName>
    <deviceName>AccuContour AI-assisted Auto-contouring Tool</deviceName>
    <manufacturerName>Manteia Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023911</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010492</emdnCode>
    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC0050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:40:24.594Z</lastUpdated>
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    <udiDi>06973127400043</udiDi>
    <basicUdiDi>697312740ACCUCHECKAF</basicUdiDi>
    <tradeName>AccuCheck</tradeName>
    <deviceName>AccuCheck</deviceName>
    <manufacturerName>Manteia Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023911</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010492</emdnCode>
    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0043</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:40:22.993Z</lastUpdated>
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    <udiDi>06973127400029</udiDi>
    <basicUdiDi>697312740AccuContourXE</basicUdiDi>
    <tradeName>AccuContour</tradeName>
    <deviceName>AccuContour AI-assisted Auto-contouring Tool</deviceName>
    <manufacturerName>Manteia Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023911</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010492</emdnCode>
    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC0029</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:40:22.208Z</lastUpdated>
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    <udiDi>04056481144494</udiDi>
    <basicUdiDi>4056481RTElementsW8</basicUdiDi>
    <tradeName>RT Elements, 4.0</tradeName>
    <deviceName>RT Elements</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010492</emdnCode>
    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04056481144494</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:34:12.173Z</lastUpdated>
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    <basicUdiDi>089947500200117PR</basicUdiDi>
    <tradeName>Ethos Treatment Management</tradeName>
    <deviceName>Ethos Treatment Management</deviceName>
    <manufacturerName>Varian Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001784</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthineers Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000803</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010492</emdnCode>
    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ethos Treatment Management 3.0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:05:25.992Z</lastUpdated>
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    <tradeName>Ethos Treatment Management</tradeName>
    <deviceName>Ethos Treatment Management</deviceName>
    <manufacturerName>Varian Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001784</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthineers Nederland B.V.</authorisedRepresentativeName>
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    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ethos Treatment Management 2.1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:00:42.102Z</lastUpdated>
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    <tradeName>RT Elements, 4.5</tradeName>
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    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
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    <manufacturerName>Brainlab SE</manufacturerName>
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