<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06953393155120</udiDi>
    <basicUdiDi>69533931GAFA</basicUdiDi>
    <tradeName>06953393155120</tradeName>
    <deviceName>Video Gastroscope</deviceName>
    <manufacturerName>HUGER Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001128</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T11:17:33.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953393155045</udiDi>
    <basicUdiDi>69533931GAFA</basicUdiDi>
    <tradeName>06953393155045</tradeName>
    <deviceName>Video Gastroscope</deviceName>
    <manufacturerName>HUGER Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001128</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T11:17:30.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953393155021</udiDi>
    <basicUdiDi>69533931GAFA</basicUdiDi>
    <tradeName>06953393155021</tradeName>
    <deviceName>Video Gastroscope</deviceName>
    <manufacturerName>HUGER Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001128</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T11:17:29.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953393155014</udiDi>
    <basicUdiDi>69533931GAFA</basicUdiDi>
    <tradeName>06953393155014</tradeName>
    <deviceName>Video Gastroscope</deviceName>
    <manufacturerName>HUGER Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001128</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T11:17:27.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953393135030</udiDi>
    <basicUdiDi>69533931CH29HL3</basicUdiDi>
    <tradeName>06953393135030</tradeName>
    <deviceName>Video Choledochoscope</deviceName>
    <manufacturerName>HUGER Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001128</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020507</emdnCode>
    <emdnDescription>VIDEO CHOLEDOCOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T11:17:16.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953393135016</udiDi>
    <basicUdiDi>69533931CH20SKW</basicUdiDi>
    <tradeName>06953393135016</tradeName>
    <deviceName>Single-use Video Choledochoscope</deviceName>
    <manufacturerName>HUGER Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001128</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020507</emdnCode>
    <emdnDescription>VIDEO CHOLEDOCOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T11:17:11.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868613921</udiDi>
    <basicUdiDi>69458686BLJU</basicUdiDi>
    <tradeName>BL-20UR</tradeName>
    <deviceName>Single-use Balloon</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020585</emdnCode>
    <emdnDescription>UPPER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:19:33.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868611354</udiDi>
    <basicUdiDi>69458686ECH-110PL</basicUdiDi>
    <tradeName>ECH-X20R</tradeName>
    <deviceName>Video Choledochoscope</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020507</emdnCode>
    <emdnDescription>VIDEO CHOLEDOCOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:17:34.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868611347</udiDi>
    <basicUdiDi>69458686ECH-110PL</basicUdiDi>
    <tradeName>ECH-110R</tradeName>
    <deviceName>Video Choledochoscope</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020507</emdnCode>
    <emdnDescription>VIDEO CHOLEDOCOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:17:24.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868611170</udiDi>
    <basicUdiDi>69458686EG-UC7TW8</basicUdiDi>
    <tradeName>EG-UC7T</tradeName>
    <deviceName>Ultrasonic Gastrovideoscope</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020503</emdnCode>
    <emdnDescription>ECHO–GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:17:16.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868611156</udiDi>
    <basicUdiDi>69458686EG-UC6T-UHY</basicUdiDi>
    <tradeName>EG-UC6T-U</tradeName>
    <deviceName>Ultrasonic Gastrovideoscope</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020503</emdnCode>
    <emdnDescription>ECHO–GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:17:15.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868610128</udiDi>
    <basicUdiDi>69458686CAP-DV2</basicUdiDi>
    <tradeName>CAP-D13D</tradeName>
    <deviceName>Single-use Distal End Cap</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020585</emdnCode>
    <emdnDescription>UPPER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:12:23.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868610050</udiDi>
    <basicUdiDi>69458686CAP-ZWE</basicUdiDi>
    <tradeName>CAP-Z12</tradeName>
    <deviceName>Single-use Distal Hood</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020585</emdnCode>
    <emdnDescription>UPPER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:12:19.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868610043</udiDi>
    <basicUdiDi>69458686EG-650MN</basicUdiDi>
    <tradeName>EG-650T</tradeName>
    <deviceName>Video Gastroscope</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:12:13.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868610036</udiDi>
    <basicUdiDi>69458686EG-650MN</basicUdiDi>
    <tradeName>EG-650</tradeName>
    <deviceName>Video Gastroscope</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:12:12.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868609016</udiDi>
    <basicUdiDi>69458686ECH-110PL</basicUdiDi>
    <tradeName>ECH-X20</tradeName>
    <deviceName>Video Choledochoscope</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020507</emdnCode>
    <emdnDescription>VIDEO CHOLEDOCOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:09:41.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868609009</udiDi>
    <basicUdiDi>69458686ECH-110PL</basicUdiDi>
    <tradeName>ECH-110</tradeName>
    <deviceName>Video Choledochoscope</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020507</emdnCode>
    <emdnDescription>VIDEO CHOLEDOCOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:09:40.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868608682</udiDi>
    <basicUdiDi>69458686EG-X20SJ</basicUdiDi>
    <tradeName>EG-X20</tradeName>
    <deviceName>Video Gastroscope</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:08:52.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868607784</udiDi>
    <basicUdiDi>69458686ED-5GTQ9</basicUdiDi>
    <tradeName>ED-5GT</tradeName>
    <deviceName>Video Duodenoscope</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020508</emdnCode>
    <emdnDescription>VIDEO DUODENOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:05:36.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868607067</udiDi>
    <basicUdiDi>69458686EG-2200HF</basicUdiDi>
    <tradeName>EG-2200</tradeName>
    <deviceName>Video Gastroscope</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:04:06.147Z</lastUpdated>
  </row>
</eudamedExport>