<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>*+D804590233650D*</udiDi>
    <basicUdiDi>++D804590L2</basicUdiDi>
    <tradeName>Leadex70</tradeName>
    <deviceName></deviceName>
    <manufacturerName>de Götzen S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000013302</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040101</emdnCode>
    <emdnDescription>EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5.90.23365</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:41:08.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D804590233660E*</udiDi>
    <basicUdiDi>++D804590L2</basicUdiDi>
    <tradeName>Leadex70</tradeName>
    <deviceName></deviceName>
    <manufacturerName>de Götzen S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000013302</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040101</emdnCode>
    <emdnDescription>EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5.90.23366</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:40:53.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D804590233670F*</udiDi>
    <basicUdiDi>++D804590L2</basicUdiDi>
    <tradeName>Leadex70</tradeName>
    <deviceName></deviceName>
    <manufacturerName>de Götzen S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000013302</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040101</emdnCode>
    <emdnDescription>EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5.90.23367</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:40:44.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977274260253</udiDi>
    <basicUdiDi>697727426scannerPJ</basicUdiDi>
    <tradeName>Intraoral Scanner</tradeName>
    <deviceName>Intraoral Scanner</deviceName>
    <manufacturerName>Changsha Honchon Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000044568</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCE-IS-130</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:24:13.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975681260019</udiDi>
    <basicUdiDi>697568126IOC001MQ</basicUdiDi>
    <tradeName>06975681260019</tradeName>
    <deviceName>Intra Oral Camera</deviceName>
    <manufacturerName>Foshan Legend Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037295</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030492</emdnCode>
    <emdnDescription>INSTRUMENTS FOR DIGITAL ENDORAL RADIOLOGY - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LGD-N</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:36:28.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974721257118</udiDi>
    <basicUdiDi>697472125RAY980042C</basicUdiDi>
    <tradeName>POCT22</tradeName>
    <deviceName>Diagnostic X-ray Equipment</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040101</emdnCode>
    <emdnDescription>EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>711</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:19:10.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974721257101</udiDi>
    <basicUdiDi>697472125YOU98001C5</basicUdiDi>
    <tradeName>YOU98(P)</tradeName>
    <deviceName>Diagnostic X-ray Equipment</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040101</emdnCode>
    <emdnDescription>EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:19:09.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974721257088</udiDi>
    <basicUdiDi>697472125YOU002S3</basicUdiDi>
    <tradeName>YOU(MG)</tradeName>
    <deviceName>Diagnostic X-ray Equipment</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040101</emdnCode>
    <emdnDescription>EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:19:08.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974721257064</udiDi>
    <basicUdiDi>697472125YOU001RZ</basicUdiDi>
    <tradeName>YOU(M)</tradeName>
    <deviceName>Diagnostic X-ray Equipment</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040101</emdnCode>
    <emdnDescription>EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>706</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:19:06.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974721257002</udiDi>
    <basicUdiDi>697472125RAY68001Z2</basicUdiDi>
    <tradeName>RAY68(M)</tradeName>
    <deviceName>Diagnostic X-ray Equipment</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040101</emdnCode>
    <emdnDescription>EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06974721257002</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:19:04.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974721257040</udiDi>
    <basicUdiDi>697472125RAY9800228</basicUdiDi>
    <tradeName>RAY98(P)</tradeName>
    <deviceName>Diagnostic X-ray Equipment</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040101</emdnCode>
    <emdnDescription>EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06974721257040</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:19:02.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974721257026</udiDi>
    <basicUdiDi>697472125RAY9800126</basicUdiDi>
    <tradeName>RAY98(M)</tradeName>
    <deviceName>Diagnostic X-ray Equipment</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040101</emdnCode>
    <emdnDescription>EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06974721257026</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:19:02.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974668765011</udiDi>
    <basicUdiDi>697466876002R3</basicUdiDi>
    <tradeName>Intraoral Scanner</tradeName>
    <deviceName>Intraoral Scanner</deviceName>
    <manufacturerName>Hunan Vsmile Biotechnology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000051840</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VLS100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:08:14.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974600260482</udiDi>
    <basicUdiDi>697460026intraloralDRWU</basicUdiDi>
    <tradeName>BonSensor</tradeName>
    <deviceName>Digital ntraoral X-Ray Imaging System</deviceName>
    <manufacturerName>Changzhou Boen Zhongding Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021444</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:40:47.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566270020</udiDi>
    <basicUdiDi>697456627S7000HR</basicUdiDi>
    <tradeName>Digital Intraoral Scannner System</tradeName>
    <deviceName>Digital Intraoral Scannner System</deviceName>
    <manufacturerName>Fussen Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009373</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rule13, Annex VIII</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:29:11.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566270006</udiDi>
    <basicUdiDi>697456627S6000HJ</basicUdiDi>
    <tradeName>Digital Intraoral Scanner System</tradeName>
    <deviceName>Digital Intraoral Scannner System</deviceName>
    <manufacturerName>Fussen Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009373</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S6000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:29:08.939Z</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>06973130880320</udiDi>
    <basicUdiDi>697313088HDXQZ</basicUdiDi>
    <tradeName>Dental X-ray Unit</tradeName>
    <deviceName>Dental X-ray Unit</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103040101</emdnCode>
    <emdnDescription>EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HDX-7030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:40:51.070Z</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>
</eudamedExport>