<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03760172650294</udiDi>
    <basicUdiDi>3760172657H5W7ZZ8</basicUdiDi>
    <tradeName>FDX Visionary-DR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APELEM</manufacturerName>
    <manufacturerSrn>FR-MF-000008953</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900103</emdnCode>
    <emdnDescription>X–RAY BONE DENSITOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:36:18.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760172650331</udiDi>
    <basicUdiDi>3760172657H5W7ZZ8</basicUdiDi>
    <tradeName>RADIOSCORE (standard version)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APELEM</manufacturerName>
    <manufacturerSrn>FR-MF-000008953</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900103</emdnCode>
    <emdnDescription>X–RAY BONE DENSITOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:36:16.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760172650348</udiDi>
    <basicUdiDi>3760172657H5W7ZZ8</basicUdiDi>
    <tradeName>RADIOSCORE (compact version)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APELEM</manufacturerName>
    <manufacturerSrn>FR-MF-000008953</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900103</emdnCode>
    <emdnDescription>X–RAY BONE DENSITOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:36:08.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B052PHCTM40</udiDi>
    <basicUdiDi>++B052PHANTOMTU</basicUdiDi>
    <tradeName>Model 4 Phantom</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mindways Software, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012877</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900180</emdnCode>
    <emdnDescription>BONE DENSITOMETRY SYSTEMS - HARDWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B052PHCTM40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B052PHQAM30X</udiDi>
    <basicUdiDi>++B052PHANTOMTU</basicUdiDi>
    <tradeName>Model 3 QA Phantom</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mindways Software, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012877</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900180</emdnCode>
    <emdnDescription>BONE DENSITOMETRY SYSTEMS - HARDWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B214OSTBSIV400</udiDi>
    <basicUdiDi>++B214OSTBSI29</basicUdiDi>
    <tradeName>TBS OSTEO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medimaps Group SA</manufacturerName>
    <manufacturerSrn>CH-MF-000039146</manufacturerSrn>
    <authorisedRepresentativeName>Med-Imaps SASU</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038706</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900192</emdnCode>
    <emdnDescription>BONE DENSITOMETRY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OS-TBSi</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:20:57.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437021740011</udiDi>
    <basicUdiDi>84370217403DSHAPERGA</basicUdiDi>
    <tradeName>3D-SHAPER</tradeName>
    <deviceName>3D-SHAPER</deviceName>
    <manufacturerName>3D-Shaper Medical S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000001324</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900182</emdnCode>
    <emdnDescription>BONE DENSITOMETRY SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D-SHAPER</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:11:17.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050713040000</udiDi>
    <basicUdiDi>805071304BSI10YP</basicUdiDi>
    <tradeName>Tecnologie Avanzate T.A. srl</tradeName>
    <deviceName>Bone Strain Index</deviceName>
    <manufacturerName>Tecnologie Avanzate T.A. s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008864</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900192</emdnCode>
    <emdnDescription>BONE DENSITOMETRY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSI1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:42:14.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290018016121</udiDi>
    <basicUdiDi>7290018016HealthOST2L</basicUdiDi>
    <tradeName>HealthOST</tradeName>
    <deviceName>HealthOST</deviceName>
    <manufacturerName>Nano-X AI Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000010234</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900192</emdnCode>
    <emdnDescription>BONE DENSITOMETRY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HealthOST 1.1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:22:34.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>03663999000344</udiDi>
    <basicUdiDi>3663999BMD01XZ</basicUdiDi>
    <tradeName>AutoDensity</tradeName>
    <deviceName>AutoDensity</deviceName>
    <manufacturerName>EOS imaging</manufacturerName>
    <manufacturerSrn>FR-MF-000000502</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900192</emdnCode>
    <emdnDescription>BONE DENSITOMETRY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AutoDensity</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T10:32:49.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800008400046</udiDi>
    <basicUdiDi>088000084UBDA62</basicUdiDi>
    <tradeName>SONOST-3000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OsteoSys Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000010177</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900102</emdnCode>
    <emdnDescription>ULTRASOUND BONE DENSITOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SONOST-3000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:46.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437021740035</udiDi>
    <basicUdiDi>84370217403DSHAPERGA</basicUdiDi>
    <tradeName>3D-SHAPER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3D-Shaper Medical S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000001324</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900182</emdnCode>
    <emdnDescription>BONE DENSITOMETRY SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D-SHAPER ver 2.13</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T07:35:41.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437021740059</udiDi>
    <basicUdiDi>84370217403DSHAPERGA</basicUdiDi>
    <tradeName>3D-SHAPER Ver.2.14</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3D-Shaper Medical S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000001324</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900182</emdnCode>
    <emdnDescription>BONE DENSITOMETRY SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D-SHAPER</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T07:35:41.608Z</lastUpdated>
  </row>
</eudamedExport>