<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>G140ANNALISECONTAINER90</udiDi>
    <basicUdiDi>++G140ANNALISECONTAINERR9</basicUdiDi>
    <tradeName>HAI-RadX Suite</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANNALISECONTAINER9</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:03:49.269Z</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AnnaliseENTP3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:03:49.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>G140ANNALISEENTP40</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AnnaliseENTP4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:03:49.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>G140ANNALISEENTP50</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AnnaliseENTP5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:03:49.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>G140ANNALISEENTP70</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANNALISEENTP7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:03:49.189Z</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANNALISEWEBVIEWER2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:03:49.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>G140HAIRADXSUITECTC20</udiDi>
    <basicUdiDi>++G140ANNALISECONTAINERR9</basicUdiDi>
    <tradeName>HAI-RadX Suite</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAI-RadX Suite CTC 2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:03:49.130Z</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Annalisecontainer4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T19:23:40.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>G140ANNALISECONTAINER50</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Annalisecontainer5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T19:23:40.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812231034927</udiDi>
    <basicUdiDi>0812231038X-10-XXXXWW</basicUdiDi>
    <tradeName>Pixa</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Santa Barbara Imaging Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007262</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020404</emdnCode>
    <emdnDescription>REMOTE CONTROL UNITS FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T13:58:49.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812231034453</udiDi>
    <basicUdiDi>0812231038X-10-XXXXWW</basicUdiDi>
    <tradeName>Omni</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Santa Barbara Imaging Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007262</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020404</emdnCode>
    <emdnDescription>REMOTE CONTROL UNITS FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T13:58:48.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812231034439</udiDi>
    <basicUdiDi>0812231038X-10-XXXXWW</basicUdiDi>
    <tradeName>Omni</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Santa Barbara Imaging Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007262</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020405</emdnCode>
    <emdnDescription>SURGICAL CAMERAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T13:58:47.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812231034415</udiDi>
    <basicUdiDi>0812231038X-10-XXXXWW</basicUdiDi>
    <tradeName>Omni</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Santa Barbara Imaging Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007262</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T13:58:46.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812231033937</udiDi>
    <basicUdiDi>0812231038X-10-XXXXWW</basicUdiDi>
    <tradeName>Pixa</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Santa Barbara Imaging Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007262</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020404</emdnCode>
    <emdnDescription>REMOTE CONTROL UNITS FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T13:58:45.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812231033890</udiDi>
    <basicUdiDi>0812231038X-10-XXXXWW</basicUdiDi>
    <tradeName>Pixa</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Santa Barbara Imaging Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007262</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020405</emdnCode>
    <emdnDescription>SURGICAL CAMERAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T13:58:44.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812231033883</udiDi>
    <basicUdiDi>0812231038X-10-XXXXWW</basicUdiDi>
    <tradeName>Pixa</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Santa Barbara Imaging Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007262</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020405</emdnCode>
    <emdnDescription>SURGICAL CAMERAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T13:58:43.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812231033876</udiDi>
    <basicUdiDi>0812231038X-10-XXXXWW</basicUdiDi>
    <tradeName>PIxa</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Santa Barbara Imaging Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007262</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020405</emdnCode>
    <emdnDescription>SURGICAL CAMERAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T13:58:42.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812231033869</udiDi>
    <basicUdiDi>0812231038X-10-XXXXWW</basicUdiDi>
    <tradeName>Pixa</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Santa Barbara Imaging Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007262</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020405</emdnCode>
    <emdnDescription>SURGICAL CAMERAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T13:58:40.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812231033821</udiDi>
    <basicUdiDi>0812231038X-10-XXXXWW</basicUdiDi>
    <tradeName>Pixa</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Santa Barbara Imaging Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007262</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T13:58:39.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056038304578</udiDi>
    <basicUdiDi>50560383BloodPressureMK</basicUdiDi>
    <tradeName>05056038304578</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GBUK Group</manufacturerName>
    <manufacturerSrn>GB-MF-000002238</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T06:08:22.483Z</lastUpdated>
  </row>
</eudamedExport>