<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CCT1899E</udiDi>
    <basicUdiDi>B-CCT1899E</basicUdiDi>
    <tradeName>D-CCT1899E</tradeName>
    <deviceName>CCT189</deviceName>
    <manufacturerName>Phantom Laboratory</manufacturerName>
    <manufacturerSrn>US-MF-000027490</manufacturerSrn>
    <authorisedRepresentativeName>Hoff &amp; Lowendahl AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001888</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z119080</emdnCode>
    <emdnDescription>VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCT189</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:57:40.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CCT1628S</udiDi>
    <basicUdiDi>B-CCT1628S</basicUdiDi>
    <tradeName>CCT162</tradeName>
    <deviceName>CCT162</deviceName>
    <manufacturerName>Phantom Laboratory</manufacturerName>
    <manufacturerSrn>US-MF-000027490</manufacturerSrn>
    <authorisedRepresentativeName>Hoff &amp; Lowendahl AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001888</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z119080</emdnCode>
    <emdnDescription>VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCT162</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:57:39.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>88001957000110</udiDi>
    <basicUdiDi>B-88001957000110</basicUdiDi>
    <tradeName>88001957000110</tradeName>
    <deviceName>WISKY</deviceName>
    <manufacturerName>ARK INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000016123</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z119092</emdnCode>
    <emdnDescription>VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>210330V100</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:23:15.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>86989403917330</udiDi>
    <basicUdiDi>B-86989403917330</basicUdiDi>
    <tradeName>Sabit Lazer</tradeName>
    <deviceName>Fixed Laser</deviceName>
    <manufacturerName>RADON TIBBİ MALZEMELER İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000018717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z119010</emdnCode>
    <emdnDescription>LASER SYSTEMS FOR PATIENT POSITIONING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RKN000002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:28:05.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>86989403900264</udiDi>
    <basicUdiDi>B-86989403900264</basicUdiDi>
    <tradeName>Hareketli Lazer</tradeName>
    <deviceName>Moving Laser</deviceName>
    <manufacturerName>RADON TIBBİ MALZEMELER İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000018717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z119010</emdnCode>
    <emdnDescription>LASER SYSTEMS FOR PATIENT POSITIONING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RKN000003</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:23:11.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>37700160100094</udiDi>
    <basicUdiDi>B-37700160100094</basicUdiDi>
    <tradeName>Breast-SlimView®</tradeName>
    <deviceName>BreastSlim View</deviceName>
    <manufacturerName>Hera-MI</manufacturerName>
    <manufacturerSrn>FR-MF-000007290</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z119082</emdnCode>
    <emdnDescription>VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Breast-SlimView®</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:50:09.839Z</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>08809590100006</udiDi>
    <basicUdiDi>B-08809590100006</basicUdiDi>
    <tradeName>MEDIPPRO</tradeName>
    <deviceName>MEDIPPRO</deviceName>
    <manufacturerName>MEDICAL IP Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000013954</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11900801</emdnCode>
    <emdnDescription>BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MEDIP Pro V2.0 User Manual (2024.03 Revision 1.0.0)</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:16:18.816Z</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>08720165025039</udiDi>
    <basicUdiDi>B-08720165025039</basicUdiDi>
    <tradeName>Comfort Marker 2.0 Docking Station</tradeName>
    <deviceName>Comfort Marker 2.0 Docking Station</deviceName>
    <manufacturerName>Medical Precision B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z119099</emdnCode>
    <emdnDescription>VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:06:19.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720165025022</udiDi>
    <basicUdiDi>B-08720165025022</basicUdiDi>
    <tradeName>Comfort Marker 2.0 Control Unit and Pen</tradeName>
    <deviceName>Comfort Market 2.0 Control Unit and Pen</deviceName>
    <manufacturerName>Medical Precision B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z119099</emdnCode>
    <emdnDescription>VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:06:17.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720165025008</udiDi>
    <basicUdiDi>B-08720165025008</basicUdiDi>
    <tradeName>Comfort Marker 2.0 Safety Needle</tradeName>
    <deviceName>Comfort Marker 2.0 Safety Needle</deviceName>
    <manufacturerName>Medical Precision B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z119099</emdnCode>
    <emdnDescription>VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:06:15.427Z</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>
</eudamedExport>