<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00815137020049</udiDi>
    <basicUdiDi>00815137020049B6</basicUdiDi>
    <tradeName>00815137020049</tradeName>
    <deviceName>R-SPOT</deviceName>
    <manufacturerName>Beekley Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007055</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030585</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:15:38.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815137020032</udiDi>
    <basicUdiDi>00815137020032AM</basicUdiDi>
    <tradeName>00815137020032</tradeName>
    <deviceName>D-SPOT</deviceName>
    <manufacturerName>Beekley Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007055</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030585</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:15:34.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815137020025</udiDi>
    <basicUdiDi>00815137020025AQ</basicUdiDi>
    <tradeName>00815137020025</tradeName>
    <deviceName>L-SPOT</deviceName>
    <manufacturerName>Beekley Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007055</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030585</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:15:33.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815137020018</udiDi>
    <basicUdiDi>00815137020018AT</basicUdiDi>
    <tradeName>00815137020018</tradeName>
    <deviceName>Y-SPOT</deviceName>
    <manufacturerName>Beekley Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007055</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030585</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:15:32.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815137020001</udiDi>
    <basicUdiDi>00815137020001AA</basicUdiDi>
    <tradeName>00815137020001</tradeName>
    <deviceName>X-SPOT</deviceName>
    <manufacturerName>Beekley Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007055</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030585</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:15:32.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>G140ANNALISECONTAINER40</udiDi>
    <basicUdiDi>++G140ANNALISECONTAINERR9</basicUdiDi>
    <tradeName>Annalise Container</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Harrison-AI Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010247</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030582</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Annalisecontainer4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:35:39.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>G140ANNALISEWEBVIEWER20</udiDi>
    <basicUdiDi>++G140WebViewer72</basicUdiDi>
    <tradeName>Annalise Web Viewer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Harrison-AI Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010247</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030582</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANNALISEWEBVIEWER2</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:35:32.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>G140ANNALISEENTP30</udiDi>
    <basicUdiDi>++G140AnnaliseEnterprisEM</basicUdiDi>
    <tradeName>Annalise Enterprise</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Harrison-AI Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010247</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030582</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AnnaliseENTP3</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:35:31.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540217059607</udiDi>
    <basicUdiDi>45402170100000000000009T4</basicUdiDi>
    <tradeName>Mobile X-ray System MobileDaRt Evolution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shimadzu Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000025145</manufacturerSrn>
    <authorisedRepresentativeName>Shimadzu Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000013563</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030599</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>566-20000-06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T14:46:56.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540217064977</udiDi>
    <basicUdiDi>45402170100000000000010SM</basicUdiDi>
    <tradeName>Mobile X-ray System MobileArt Evolution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shimadzu Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000025145</manufacturerSrn>
    <authorisedRepresentativeName>Shimadzu Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000013563</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030599</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>566-20000-81</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T14:46:55.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B720ELUNG23CE0</udiDi>
    <basicUdiDi>++B720ELUNGCEVU</basicUdiDi>
    <tradeName>Brainomix 360 e-Lung</tradeName>
    <deviceName>Brainomix 360 e-Lung</deviceName>
    <manufacturerName>Brainomix Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000017336</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030592</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Brainomix 360 e-Lung v2.3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:56:49.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B664AMM71%</udiDi>
    <basicUdiDi>++B664MICAC6</basicUdiDi>
    <tradeName>Tempus Pixel</tradeName>
    <deviceName>Tempus Pixel</deviceName>
    <manufacturerName>Arterys Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001775</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030582</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMM7</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:56:35.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+B720ECTP120CE0</udiDi>
    <basicUdiDi>++B720ECTPEMRICEL2</basicUdiDi>
    <tradeName>Brainomix 360 e-CTP/e-MRI</tradeName>
    <deviceName>Brainomix 360 e-CTP/e-MRI</deviceName>
    <manufacturerName>Brainomix Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000017336</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030592</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>e-CTP/e-MRI 12.0</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:56:22.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+B720ECTA120CE0</udiDi>
    <basicUdiDi>++B720ECTACEQR</basicUdiDi>
    <tradeName>Brainomix 360 e-CTA</tradeName>
    <deviceName>Brainomix 360 e-CTA</deviceName>
    <manufacturerName>Brainomix Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000017336</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030592</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>e-CTA 12.0</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:56:22.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+B720EASPECTS120CE0</udiDi>
    <basicUdiDi>++B720EASPECTSCEGK</basicUdiDi>
    <tradeName>Brainomix 360 e-ASPECTS</tradeName>
    <deviceName>Brainomix 360 e-ASPECTS</deviceName>
    <manufacturerName>Brainomix Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000017336</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030592</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>e-ASPECTS 12.0</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:56:21.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B220NEURO020</udiDi>
    <basicUdiDi>++B220NeuroFP</basicUdiDi>
    <tradeName>TeraRecon Neuro</tradeName>
    <deviceName>TeraRecon Neuro</deviceName>
    <manufacturerName>TeraRecon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030592</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:47:52.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B220INTUITION040</udiDi>
    <basicUdiDi>++B220INTUITIONFV</basicUdiDi>
    <tradeName>Intuition</tradeName>
    <deviceName>Intuition</deviceName>
    <manufacturerName>TeraRecon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030592</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:47:51.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B220CARDIOVASCCALCT10</udiDi>
    <basicUdiDi>++B220CALCIFICATIONCTLV</basicUdiDi>
    <tradeName>TeraRecon Cardiovascular.Calcification.CT</tradeName>
    <deviceName>TeraRecon Cardiovascular.Calcification.CT</deviceName>
    <manufacturerName>TeraRecon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030592</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:47:50.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B220CARDIACCHAMBERSMR10</udiDi>
    <basicUdiDi>++B220CHAMBERSMRZS</basicUdiDi>
    <tradeName>TeraRecon Cardiac.Chambers.MR</tradeName>
    <deviceName>TeraRecon Cardiac.Chambers.MR</deviceName>
    <manufacturerName>TeraRecon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030592</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:47:33.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B220AORTACT0</udiDi>
    <basicUdiDi>++B220AORTACTQP</basicUdiDi>
    <tradeName>TeraRecon Aorta.CT</tradeName>
    <deviceName>TeraRecon Aorta.CT</deviceName>
    <manufacturerName>TeraRecon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030592</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:47:32.999Z</lastUpdated>
  </row>
</eudamedExport>