<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06949567065029</udiDi>
    <basicUdiDi>694956700001M6</basicUdiDi>
    <tradeName>UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangdong Softlink Medical Innovation Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025833</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020703</emdnCode>
    <emdnDescription>COLPOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4K-A1-103（B）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:09.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949567066019</udiDi>
    <basicUdiDi>694956700001M6</basicUdiDi>
    <tradeName>UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangdong Softlink Medical Innovation Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025833</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020703</emdnCode>
    <emdnDescription>COLPOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4K-A1-104（A）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:09.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949567066026</udiDi>
    <basicUdiDi>694956700001M6</basicUdiDi>
    <tradeName>UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangdong Softlink Medical Innovation Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025833</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020703</emdnCode>
    <emdnDescription>COLPOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4K-A1-104（B）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:09.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949567071013</udiDi>
    <basicUdiDi>694956700001M6</basicUdiDi>
    <tradeName>UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangdong Softlink Medical Innovation Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025833</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020703</emdnCode>
    <emdnDescription>COLPOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-01-101 (A)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:09.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949567071020</udiDi>
    <basicUdiDi>694956700001M6</basicUdiDi>
    <tradeName>UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangdong Softlink Medical Innovation Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025833</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020703</emdnCode>
    <emdnDescription>COLPOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-01-101 (B)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:09.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949567072010</udiDi>
    <basicUdiDi>694956700001M6</basicUdiDi>
    <tradeName>UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangdong Softlink Medical Innovation Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025833</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020703</emdnCode>
    <emdnDescription>COLPOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-01-102 (A)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:09.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949567072027</udiDi>
    <basicUdiDi>694956700001M6</basicUdiDi>
    <tradeName>UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangdong Softlink Medical Innovation Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025833</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020703</emdnCode>
    <emdnDescription>COLPOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-01-102 (B)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:09.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>04953170465925</udiDi>
    <basicUdiDi>495317000130B5</basicUdiDi>
    <tradeName>URETERO-RENO FIBERSCOPE OLYMPUS URF-P7R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OLYMPUS MEDICAL SYSTEMS CORP.</manufacturerName>
    <manufacturerSrn>JP-MF-000008016</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020713</emdnCode>
    <emdnDescription>URETERORENOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N5781952</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T03:45:14.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>05707480146345</udiDi>
    <basicUdiDi>5707480301005302588</basicUdiDi>
    <tradeName>Ambu® aScope™ 4 Cysto</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ambu A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020711</emdnCode>
    <emdnDescription>VIDEO CYSTOURETHROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601005000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:53:12.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521744110</udiDi>
    <basicUdiDi>0763000B00005707U</basicUdiDi>
    <tradeName>TruClearTM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020704</emdnCode>
    <emdnDescription>HYSTEROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72203012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:46:26.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521744103</udiDi>
    <basicUdiDi>0763000B00005707U</basicUdiDi>
    <tradeName>TruClearTM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020704</emdnCode>
    <emdnDescription>HYSTEROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7209509</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:46:26.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521744097</udiDi>
    <basicUdiDi>0763000B00005707U</basicUdiDi>
    <tradeName>TruClear™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020704</emdnCode>
    <emdnDescription>HYSTEROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72204064</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:45:59.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945014205024</udiDi>
    <basicUdiDi>69450142Z120207C2C</basicUdiDi>
    <tradeName>06945014205024</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Tiansong Medical Instrument Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008834</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020701</emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:02.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945014205079</udiDi>
    <basicUdiDi>69450142Z120207C2C</basicUdiDi>
    <tradeName>06945014205079</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Tiansong Medical Instrument Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008834</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020701</emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0012</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:02.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945014205147</udiDi>
    <basicUdiDi>69450142Z120207C2C</basicUdiDi>
    <tradeName>06945014205147</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Tiansong Medical Instrument Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008834</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020701</emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0013</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:02.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945014205253</udiDi>
    <basicUdiDi>69450142Z120207B2A</basicUdiDi>
    <tradeName>06945014205253</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Tiansong Medical Instrument Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008834</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020701</emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0022</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:02.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945014205789</udiDi>
    <basicUdiDi>69450142Z120207A28</basicUdiDi>
    <tradeName>06945014205789</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Tiansong Medical Instrument Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008834</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020701</emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0211</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:02.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945014205840</udiDi>
    <basicUdiDi>69450142Z120207B2A</basicUdiDi>
    <tradeName>06945014205840</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Tiansong Medical Instrument Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008834</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020701</emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0310</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:02.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945014205871</udiDi>
    <basicUdiDi>69450142Z120207B2A</basicUdiDi>
    <tradeName>06945014205871</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Tiansong Medical Instrument Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008834</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020701</emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0312</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:02.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945014205895</udiDi>
    <basicUdiDi>69450142Z120207B2A</basicUdiDi>
    <tradeName>06945014205895</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Tiansong Medical Instrument Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008834</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020701</emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0313</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:02.020Z</lastUpdated>
  </row>
</eudamedExport>