<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800021800014</udiDi>
    <basicUdiDi>B-08800021800014</basicUdiDi>
    <tradeName>08800021800014</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIGIMED Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016608</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMC-03</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:42:43.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800021800007</udiDi>
    <basicUdiDi>B-08800021800007</basicUdiDi>
    <tradeName>08800021800007</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIGIMED Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016608</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMC-04</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:42:41.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566272109</udiDi>
    <basicUdiDi>B-06974566272109</basicUdiDi>
    <tradeName>Digital Intraoral Imaging Plate System</tradeName>
    <deviceName>Digital Intraoral Imaging Plate System</deviceName>
    <manufacturerName>Fussen Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009373</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F210</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:51:12.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566272055</udiDi>
    <basicUdiDi>B-06974566272055</basicUdiDi>
    <tradeName>06974566272055</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fussen Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009373</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F200</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:51:10.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800016400694</udiDi>
    <basicUdiDi>88000164VEXP300067JC</basicUdiDi>
    <tradeName>EzRay Air Portable</tradeName>
    <deviceName>Dental X-ray System with Extraoral Source</deviceName>
    <manufacturerName>VATECH Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000013011</manufacturerSrn>
    <authorisedRepresentativeName>VATECH GLOBAL FRANCE SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009694</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDH-UM-067</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:23.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033675601151</udiDi>
    <basicUdiDi>803367560DIGIPORTYR</basicUdiDi>
    <tradeName>NEW LIFE RADIOLOGY</tradeName>
    <deviceName>DIGIPORT</deviceName>
    <manufacturerName>NEW LIFE RADIOLOGY Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000044708</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIGIPORT-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:09:59.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760278266740</udiDi>
    <basicUdiDi>801337602782D0011CS</basicUdiDi>
    <tradeName>SOPIX PLUG-IN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOPRO</manufacturerName>
    <manufacturerSrn>FR-MF-000000833</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S_802_8000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:18:49.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760278266726</udiDi>
    <basicUdiDi>801337602782D0012CU</basicUdiDi>
    <tradeName>SOPIX2 PLUG-IN</tradeName>
    <deviceName>SOPIX2 PLUG-IN</deviceName>
    <manufacturerName>SOPRO</manufacturerName>
    <manufacturerSrn>FR-MF-000000833</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S_802_7000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:18:48.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760278262698</udiDi>
    <basicUdiDi>801337602782D0003CT</basicUdiDi>
    <tradeName>SOPIX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOPRO</manufacturerName>
    <manufacturerSrn>FR-MF-000000833</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S_802_3008</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:18:43.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760278262674</udiDi>
    <basicUdiDi>801337602782D0009D7</basicUdiDi>
    <tradeName>SOPIX2</tradeName>
    <deviceName>SOPIX2</deviceName>
    <manufacturerName>SOPRO</manufacturerName>
    <manufacturerSrn>FR-MF-000000833</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S_802_0008</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:18:42.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974276290172</udiDi>
    <basicUdiDi>697427629002MC</basicUdiDi>
    <tradeName>Dental X-ray Units</tradeName>
    <deviceName>Dental X-ray Units</deviceName>
    <manufacturerName>Zhuhai Siger Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017163</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIRAY</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:49:50.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973130880030</udiDi>
    <basicUdiDi>697313088HDRQM</basicUdiDi>
    <tradeName>Digital Dental X-ray Imaging System</tradeName>
    <deviceName>Digital Dental X-Ray Imaging System</deviceName>
    <manufacturerName>Shanghai Handy Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030072</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HDR-500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:40:33.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975132953842</udiDi>
    <basicUdiDi>697259778EX001PV</basicUdiDi>
    <tradeName>HyperLight</tradeName>
    <deviceName>Hand-held Dental X-ray System</deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7080004</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:03:51.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972597784837</udiDi>
    <basicUdiDi>697259778EN001MP</basicUdiDi>
    <tradeName>NanoPix1, NanoPix2</tradeName>
    <deviceName>Intraoral Digital Imaging Sensor</deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6980002</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:59:51.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941877819507</udiDi>
    <basicUdiDi>697259778EX003PZ</basicUdiDi>
    <tradeName>HyperLight-M</tradeName>
    <deviceName>Hand-held Dental X-ray System</deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7080302</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:56:58.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941877812454</udiDi>
    <basicUdiDi>697259778EN004MV</basicUdiDi>
    <tradeName>NanoPix1.5</tradeName>
    <deviceName>Intraoral Digital Imaging Sensor</deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6980090</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:56:55.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941877803179</udiDi>
    <basicUdiDi>697259778EX002PX</basicUdiDi>
    <tradeName>HyperLight-G</tradeName>
    <deviceName>Hand-held Dental X-ray System</deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>7080111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:56:45.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904269400514</udiDi>
    <basicUdiDi>890426940100173</basicUdiDi>
    <tradeName>08904269400514</tradeName>
    <deviceName>INTRASKAN DC AND IT'S VARIANTS</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>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303-000134-8</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:24:15.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904269400507</udiDi>
    <basicUdiDi>890426940100173</basicUdiDi>
    <tradeName>08904269400507</tradeName>
    <deviceName>INTRASKAN DC AND IT'S VARIANTS</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>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303-000134 -18</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:24:13.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904269400491</udiDi>
    <basicUdiDi>890426940100173</basicUdiDi>
    <tradeName>08904269400491</tradeName>
    <deviceName>INTRASKAN DC AND IT'S VARIANTS</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>MDR 2017/745</legislation>
    <emdnCode>Z1103040102</emdnCode>
    <emdnDescription>EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303-000134-21</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:24:12.673Z</lastUpdated>
  </row>
</eudamedExport>