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<eudamedExport entity="devices">
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    <udiDi>03760172650089</udiDi>
    <basicUdiDi>3760172657H5W7ZZ8</basicUdiDi>
    <tradeName>STRATOS DR</tradeName>
    <deviceName>X-ray Bone densitometers</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>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:04:02.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800008400091</udiDi>
    <basicUdiDi>088000084UBDB64</basicUdiDi>
    <tradeName>BeeTLe</tradeName>
    <deviceName>BeeTLe</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>BeeTLe</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:05:07.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800008400039</udiDi>
    <basicUdiDi>088000084UBDA62</basicUdiDi>
    <tradeName>SONOST-2000</tradeName>
    <deviceName>SONOST-3000</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-2000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:05:03.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B214OSTBSIV310</udiDi>
    <basicUdiDi>++B214OSTBSI29</basicUdiDi>
    <tradeName>TBS OSTEO</tradeName>
    <deviceName>TBS iNsight</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>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:47:32.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B214CORELABV100</udiDi>
    <basicUdiDi>++B214CORELABQJ</basicUdiDi>
    <tradeName>CORELab</tradeName>
    <deviceName>CORELab</deviceName>
    <manufacturerName>Medimaps Group SA</manufacturerName>
    <manufacturerSrn>CH-MF-000039146</manufacturerSrn>
    <authorisedRepresentativeName>Med-Imaps SASU</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038706</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900182</emdnCode>
    <emdnDescription>BONE DENSITOMETRY SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CORELAB</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:47:27.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B052PHCTM30</udiDi>
    <basicUdiDi>++B052PHANTOMTU</basicUdiDi>
    <tradeName>Model 3 CT Calibration Phantom</tradeName>
    <deviceName>Model 4 Phantom</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>13002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:46:35.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+B214OSPTMV30</udiDi>
    <basicUdiDi>++B214OSPTM55</basicUdiDi>
    <tradeName>TBS Osteo</tradeName>
    <deviceName>TBS Calibration Phantom</deviceName>
    <manufacturerName>Medimaps Group SA</manufacturerName>
    <manufacturerSrn>CH-MF-000039146</manufacturerSrn>
    <authorisedRepresentativeName>Med-Imaps SASU</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038706</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11900182</emdnCode>
    <emdnDescription>BONE DENSITOMETRY SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OS-PTM</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:46:22.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IL-MF-000015561YG</udiDi>
    <basicUdiDi>B-IL-MF-000015561YG</basicUdiDi>
    <tradeName>MiniOmni</tradeName>
    <deviceName>MiniOmni</deviceName>
    <manufacturerName>BeamMed Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000015561</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11900102</emdnCode>
    <emdnDescription>ULTRASOUND BONE DENSITOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-0608</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:18.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-25.41-3100V3</udiDi>
    <basicUdiDi>B-25.41-3100V3</basicUdiDi>
    <tradeName>D-25.41-3100V3</tradeName>
    <deviceName>Inus D</deviceName>
    <manufacturerName>medical ECONET GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004982</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11900103</emdnCode>
    <emdnDescription>X–RAY BONE DENSITOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25.41-3100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:47:37.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-25.41-1300UX</udiDi>
    <basicUdiDi>B-25.41-1300UX</basicUdiDi>
    <tradeName>D-25.41-1300UX</tradeName>
    <deviceName>Inus S</deviceName>
    <manufacturerName>medical ECONET GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004982</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11900102</emdnCode>
    <emdnDescription>ULTRASOUND BONE DENSITOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25.41-1300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:47:36.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800088200000</udiDi>
    <basicUdiDi>B-08800088200000</basicUdiDi>
    <tradeName>08800088200000</tradeName>
    <deviceName>InAlyzer AIR</deviceName>
    <manufacturerName>MEDIKORS INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000026353</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11900103</emdnCode>
    <emdnDescription>X–RAY BONE DENSITOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>InAlyzer_AIR Brochure</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:23:58.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760172650355</udiDi>
    <basicUdiDi>3760172657H5W7ZZ8</basicUdiDi>
    <tradeName>RADIOSCORE 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>2026-07-08T19:51:58.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760172650249</udiDi>
    <basicUdiDi>3760172657H5W7ZZ8</basicUdiDi>
    <tradeName>STRATOS</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>2026-07-07T19:36:57.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760172650362</udiDi>
    <basicUdiDi>3760172657H5W7ZZ8</basicUdiDi>
    <tradeName>STRATOS (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>2026-07-07T19:36:54.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760172650256</udiDi>
    <basicUdiDi>3760172657H5W7ZZ8</basicUdiDi>
    <tradeName>MEDIX90 (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>2026-07-07T19:36:36.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760172650324</udiDi>
    <basicUdiDi>3760172657H5W7ZZ8</basicUdiDi>
    <tradeName>MEDIX90 (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>2026-07-07T19:36:35.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760172650096</udiDi>
    <basicUdiDi>3760172657H5W7ZZ8</basicUdiDi>
    <tradeName>MEDIX 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>2026-07-07T19:36:33.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760172650270</udiDi>
    <basicUdiDi>3760172657H5W7ZZ8</basicUdiDi>
    <tradeName>FDX Visionary-A (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>2026-07-07T19:36:32.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760172650287</udiDi>
    <basicUdiDi>3760172657H5W7ZZ8</basicUdiDi>
    <tradeName>FDX Visionary-A (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>2026-07-07T19:36:22.717Z</lastUpdated>
  </row>
  <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>
</eudamedExport>