<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06955053701609</udiDi>
    <basicUdiDi>695505370235KY-IR-6-1PZ</basicUdiDi>
    <tradeName>Sterile Bladder Irrigation Sets for Single Use</tradeName>
    <deviceName>Sterile Bladder Irrigation Sets for Single Use</deviceName>
    <manufacturerName>VITAIMED INSTRUMENT CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000033172</manufacturerSrn>
    <authorisedRepresentativeName>VITAIMED GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000029575</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040201</emdnCode>
    <emdnDescription>BLADDER IRRIGATION KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KY-IR-6-2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:45:24.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>08427860901070</udiDi>
    <basicUdiDi>8427860URO2100000021ABM</basicUdiDi>
    <tradeName>Bexen Medical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OIARSO, S. COOP</manufacturerName>
    <manufacturerSrn>ES-MF-000000866</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040201</emdnCode>
    <emdnDescription>BLADDER IRRIGATION KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>901.07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:29:52.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952450970126</udiDi>
    <basicUdiDi>69524509C6L01H5</basicUdiDi>
    <tradeName>OptimAblate™ Tubing Set</tradeName>
    <deviceName>OptimAblate™ Tubing Set</deviceName>
    <manufacturerName>Shanghai MicroPort EP MedTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008518</manufacturerSrn>
    <authorisedRepresentativeName>MicroPort Medical B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000166</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPAB 3200</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:46:24.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720712</udiDi>
    <basicUdiDi>B-06951233720712</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-205-02-B(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:25.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720699</udiDi>
    <basicUdiDi>B-06951233720699</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-205-02-A(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:24.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720309</udiDi>
    <basicUdiDi>B-06951233720309</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-203-E(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:14.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720293</udiDi>
    <basicUdiDi>B-06951233720293</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-203-D(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:13.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720286</udiDi>
    <basicUdiDi>B-06951233720286</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-203-C(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:12.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720279</udiDi>
    <basicUdiDi>B-06951233720279</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-203-B(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:06.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720262</udiDi>
    <basicUdiDi>B-06951233720262</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-203-A(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:05.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720200</udiDi>
    <basicUdiDi>B-06951233720200</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-202-E(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:04.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720132</udiDi>
    <basicUdiDi>B-06951233720132</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-202-C(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:02.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720125</udiDi>
    <basicUdiDi>B-06951233720125</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-202-B(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:39:56.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720118</udiDi>
    <basicUdiDi>B-06951233720118</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-202-A(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:39:55.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233719020</udiDi>
    <basicUdiDi>B-06951233719020</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-202-D(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:39:54.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950570201496</udiDi>
    <basicUdiDi>B-06950570201496</basicUdiDi>
    <tradeName>06950570201496</tradeName>
    <deviceName>Irrigation Set</deviceName>
    <manufacturerName>Suzhou New Area Mingji Macromolecule Medical Apparatus Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC0301</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:19:54.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729752998</udiDi>
    <basicUdiDi>01915060000000000000586NV</basicUdiDi>
    <tradeName>SAPS™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0067201010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:29.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>03615140001557</udiDi>
    <basicUdiDi>361514H3IRRI171VW</basicUdiDi>
    <tradeName>SET D'IRRIGATION POUR M-M SURGIC XT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HYGITECH</manufacturerName>
    <manufacturerSrn>FR-MF-000007549</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HY1-110034</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T10:34:24.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>03615140001588</udiDi>
    <basicUdiDi>361514H3IRRI171VW</basicUdiDi>
    <tradeName>SET D'IRRI NOUVAG/STRAUMANN SM12</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HYGITECH</manufacturerName>
    <manufacturerSrn>FR-MF-000007549</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HY1-110014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T10:34:24.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>03615140001618</udiDi>
    <basicUdiDi>361514H3IRRI171VW</basicUdiDi>
    <tradeName>STERILE IRRIGATION SYSTEMS M-M W&amp;H/NOBEL BIOCARE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HYGITECH</manufacturerName>
    <manufacturerSrn>FR-MF-000007549</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HY-110001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T10:34:24.262Z</lastUpdated>
  </row>
</eudamedExport>