<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06920907004175</udiDi>
    <basicUdiDi>B-06920907004175</basicUdiDi>
    <tradeName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</tradeName>
    <deviceName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</deviceName>
    <manufacturerName>Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024518</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN-230 W 0.4 ZXC Ⅱ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:55:32.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920907004168</udiDi>
    <basicUdiDi>B-06920907004168</basicUdiDi>
    <tradeName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</tradeName>
    <deviceName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</deviceName>
    <manufacturerName>Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024518</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN-230 W 0.4 ZSC Ⅱ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:55:31.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920907004151</udiDi>
    <basicUdiDi>B-06920907004151</basicUdiDi>
    <tradeName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</tradeName>
    <deviceName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</deviceName>
    <manufacturerName>Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024518</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN-230 S 0.4 XZC Ⅱ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:55:30.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920907004137</udiDi>
    <basicUdiDi>B-06920907004137</basicUdiDi>
    <tradeName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</tradeName>
    <deviceName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</deviceName>
    <manufacturerName>Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024518</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN-230 S 0.4 ZXC Ⅱ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:55:25.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920907004120</udiDi>
    <basicUdiDi>B-06920907004120</basicUdiDi>
    <tradeName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</tradeName>
    <deviceName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</deviceName>
    <manufacturerName>Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024518</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN-220 S 0.4 ZZC Ⅱ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:55:24.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920907004113</udiDi>
    <basicUdiDi>B-06920907004113</basicUdiDi>
    <tradeName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</tradeName>
    <deviceName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</deviceName>
    <manufacturerName>Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024518</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN-230 S 0.4 ZSC Ⅱ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:55:24.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920907004083</udiDi>
    <basicUdiDi>B-06920907004083</basicUdiDi>
    <tradeName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</tradeName>
    <deviceName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</deviceName>
    <manufacturerName>Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024518</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN-230 S 0.4 ZZC Ⅱ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:55:23.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920907004069</udiDi>
    <basicUdiDi>B-06920907004069</basicUdiDi>
    <tradeName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</tradeName>
    <deviceName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</deviceName>
    <manufacturerName>Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024518</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN-230 S 0.7 XZC Ⅱ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:55:19.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920907004052</udiDi>
    <basicUdiDi>B-06920907004052</basicUdiDi>
    <tradeName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</tradeName>
    <deviceName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</deviceName>
    <manufacturerName>Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024518</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN-240 S 0.4 XZC Ⅱ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:55:18.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920907004045</udiDi>
    <basicUdiDi>B-06920907004045</basicUdiDi>
    <tradeName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</tradeName>
    <deviceName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</deviceName>
    <manufacturerName>Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024518</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN-210 S 0.7 XZC Ⅱ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:55:17.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920907004038</udiDi>
    <basicUdiDi>B-06920907004038</basicUdiDi>
    <tradeName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</tradeName>
    <deviceName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</deviceName>
    <manufacturerName>Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024518</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN-210 S 0.4 XZC Ⅱ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:55:16.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920907004021</udiDi>
    <basicUdiDi>B-06920907004021</basicUdiDi>
    <tradeName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use</tradeName>
    <deviceName>Bipolar Open -surgery Electrosurgical Handpiece (including electrode) for Single-use</deviceName>
    <manufacturerName>Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024518</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN-200 S 0.7 XZC Ⅱ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:55:12.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920907004014</udiDi>
    <basicUdiDi>B-06920907004014</basicUdiDi>
    <tradeName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for single-use</tradeName>
    <deviceName>Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for single-use</deviceName>
    <manufacturerName>Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024518</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN-200 S 0.4 XZC Ⅱ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:55:12.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>16938775201371</udiDi>
    <basicUdiDi>B-16938775201371</basicUdiDi>
    <tradeName>16938775201371</tradeName>
    <deviceName>Radio Frequency Surgical Systems-Electrodes</deviceName>
    <manufacturerName>MedSphere International (Shanghai) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033808</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02030101</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21-A83851</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:08:28.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025630493</udiDi>
    <basicUdiDi>B-05425025630493</basicUdiDi>
    <tradeName>Fistura</tradeName>
    <deviceName></deviceName>
    <manufacturerName>F Care Systems</manufacturerName>
    <manufacturerSrn>BE-MF-000000037</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05FIS9F</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:47:31.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025630486</udiDi>
    <basicUdiDi>B-05425025630486</basicUdiDi>
    <tradeName>Fistura</tradeName>
    <deviceName></deviceName>
    <manufacturerName>F Care Systems</manufacturerName>
    <manufacturerSrn>BE-MF-000000037</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05FIS8F</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:47:30.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025630479</udiDi>
    <basicUdiDi>B-05425025630479</basicUdiDi>
    <tradeName>Fistura</tradeName>
    <deviceName></deviceName>
    <manufacturerName>F Care Systems</manufacturerName>
    <manufacturerSrn>BE-MF-000000037</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05FIS7F</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:47:28.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025630462</udiDi>
    <basicUdiDi>B-05425025630462</basicUdiDi>
    <tradeName>Fistura</tradeName>
    <deviceName></deviceName>
    <manufacturerName>F Care Systems</manufacturerName>
    <manufacturerSrn>BE-MF-000000037</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05FIS6F</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:47:26.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223037583</udiDi>
    <basicUdiDi>B-05051223037583</basicUdiDi>
    <tradeName>Essential Smoke Filter</tradeName>
    <deviceName>Essential Smoke Filter</deviceName>
    <manufacturerName>SHANDONG ZHENFU MEDICAL DEVICE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031319</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02010107</emdnCode>
    <emdnDescription>SMOKE EVACUATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3604A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:07.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223033028</udiDi>
    <basicUdiDi>B-05051223033028</basicUdiDi>
    <tradeName>Bipolar Straight Grasping Forceps, without Ratchet, 5mm x 33cm</tradeName>
    <deviceName>Bipolar Straight Grasping Forceps</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010602</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS4583</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:02:32.723Z</lastUpdated>
  </row>
</eudamedExport>