<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974721257507</udiDi>
    <basicUdiDi>697472125DR001DH</basicUdiDi>
    <tradeName>DR730</tradeName>
    <deviceName>Dental Digital Imaging Sensor</deviceName>
    <manufacturerName>Ningbo Runyes Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014741</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06974721257507</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:19:13.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974426220219</udiDi>
    <basicUdiDi>697442622DX55KD</basicUdiDi>
    <tradeName>Browiner</tradeName>
    <deviceName>Digital Radiography and Radioscopy System</deviceName>
    <manufacturerName>Shenzhen Browiner Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007025</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0801080260</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:05:50.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974426220189</udiDi>
    <basicUdiDi>697442622DX51K5</basicUdiDi>
    <tradeName>Browiner</tradeName>
    <deviceName>Digital Radiography System</deviceName>
    <manufacturerName>Shenzhen Browiner Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007025</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0801080236</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:05:50.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974426220158</udiDi>
    <basicUdiDi>697442622CX100DL</basicUdiDi>
    <tradeName>Browiner</tradeName>
    <deviceName>Mobile C-arm X-ray System</deviceName>
    <manufacturerName>Shenzhen Browiner Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007025</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0801080355</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:05:46.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974426220134</udiDi>
    <basicUdiDi>697442622PX06ML</basicUdiDi>
    <tradeName>Browiner</tradeName>
    <deviceName>Digital Radiography System</deviceName>
    <manufacturerName>Shenzhen Browiner Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007025</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0801080106</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:05:45.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974426220127</udiDi>
    <basicUdiDi>697442622MX20LR</basicUdiDi>
    <tradeName>Browiner</tradeName>
    <deviceName>Digital Radiography System</deviceName>
    <manufacturerName>Shenzhen Browiner Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007025</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0801080052</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:05:44.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974426220103</udiDi>
    <basicUdiDi>697442622MX40LX</basicUdiDi>
    <tradeName>Browiner</tradeName>
    <deviceName>Digital Radiography System</deviceName>
    <manufacturerName>Shenzhen Browiner Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007025</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0801080048</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:05:43.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974426220073</udiDi>
    <basicUdiDi>697442622MX30LU</basicUdiDi>
    <tradeName>Browiner</tradeName>
    <deviceName>Digital Radiography System</deviceName>
    <manufacturerName>Shenzhen Browiner Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007025</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0801080017</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:05:39.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971297451612</udiDi>
    <basicUdiDi>697129745002LG</basicUdiDi>
    <tradeName>Lanmage</tradeName>
    <deviceName>Mobile Digital X-ray Radiography System</deviceName>
    <manufacturerName>Shenzhen Lanmage Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001122</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:47:43.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971297451575</udiDi>
    <basicUdiDi>697129745001LE</basicUdiDi>
    <tradeName>Lanmage</tradeName>
    <deviceName>Digital X-ray Radiography System</deviceName>
    <manufacturerName>Shenzhen Lanmage Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001122</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6600B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:47:40.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415973704</udiDi>
    <basicUdiDi>69449040AB050100515W</basicUdiDi>
    <tradeName>06936415973704</tradeName>
    <deviceName>Digital Radiography System</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DigiEye 680</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:51.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938964312270</udiDi>
    <basicUdiDi>693896431200N7</basicUdiDi>
    <tradeName>06938964312270</tradeName>
    <deviceName>Direct Digital Radiology System</deviceName>
    <manufacturerName>Beijing Wandong Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014174</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GMDN Code: 37645</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:22:00.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938396400415</udiDi>
    <basicUdiDi>693839640030013XBL00000Y3</basicUdiDi>
    <tradeName>06938396400415</tradeName>
    <deviceName>Portable DR Imaging System</deviceName>
    <manufacturerName>Shantou Institute of Ultrasonic Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010834</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR-1100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:20:37.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>04549292175653</udiDi>
    <basicUdiDi>4549292fp01CY</basicUdiDi>
    <tradeName>FLAT PANEL DETECTOR AR-C4343W</tradeName>
    <deviceName>AR-D1</deviceName>
    <manufacturerName>Canon Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000013254</manufacturerSrn>
    <authorisedRepresentativeName>Canon Medical Components Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000029305</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT8-1911</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:52:48.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>04549292099454</udiDi>
    <basicUdiDi>4549292dr01CU</basicUdiDi>
    <tradeName>DIGITAL RADIOGRAPHY CXDI-810C Wireless</tradeName>
    <deviceName>CXDI-Pro</deviceName>
    <manufacturerName>Canon Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000013254</manufacturerSrn>
    <authorisedRepresentativeName>Canon Medical Components Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000029305</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT8- 1846</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:52:46.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904269409531</udiDi>
    <basicUdiDi>B-08904269409531</basicUdiDi>
    <tradeName>08904269409531</tradeName>
    <deviceName>SKANRAD 400 - High Frequency Diagnostic X-ray system</deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303-000783-4</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:24:42.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970597832022</udiDi>
    <basicUdiDi>697059783DynamicCR</basicUdiDi>
    <tradeName>YosemiteView 4343W</tradeName>
    <deviceName>X-ray Flat Panel Detector</deviceName>
    <manufacturerName>CareRay Digital Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007229</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:58:15.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970597831049</udiDi>
    <basicUdiDi>697059783DynamicCR</basicUdiDi>
    <tradeName>YosemiteView 3643W</tradeName>
    <deviceName>X-ray Flat Panel Detector</deviceName>
    <manufacturerName>CareRay Digital Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007229</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:58:08.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970597830837</udiDi>
    <basicUdiDi>697059783DR54</basicUdiDi>
    <tradeName>CareView 1800Cwe-M</tradeName>
    <deviceName>X-ray Flat Panel Detector</deviceName>
    <manufacturerName>CareRay Digital Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007229</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>083</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:58:07.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970597830752</udiDi>
    <basicUdiDi>697059783DynamicCR</basicUdiDi>
    <tradeName>EverestView 4343X</tradeName>
    <deviceName>X-ray Flat Panel Detector</deviceName>
    <manufacturerName>CareRay Digital Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007229</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>075</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:58:06.268Z</lastUpdated>
  </row>
</eudamedExport>