<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936666527992</udiDi>
    <basicUdiDi>69366665CFH4</basicUdiDi>
    <tradeName>06936666527992</tradeName>
    <deviceName>Endovenous Radiofrequency Catheter</deviceName>
    <manufacturerName>Zhejiang CuraWay Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025983</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFA 2.3-7-60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:10:41.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048004157</udiDi>
    <basicUdiDi>843404825KITRIZOLISISWG</basicUdiDi>
    <tradeName>KIT DE RF CERVICAL</tradeName>
    <deviceName>Agrupaciones Rizólisis</deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K02030103</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-RIZO2 HCSC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:28:19.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048001002</udiDi>
    <basicUdiDi>843404825KITRIZOLISISWG</basicUdiDi>
    <tradeName>KIT DE RIZOLISIS</tradeName>
    <deviceName>Agrupaciones Rizólisis</deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K02030103</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-RIZO HCSC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:28:18.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974702710687</udiDi>
    <basicUdiDi>697470271PMA001H2</basicUdiDi>
    <tradeName>06974702710687</tradeName>
    <deviceName>Multi-pole Pulmonary Artery RF Ablation Catheter</deviceName>
    <manufacturerName>Pulnovo Medical (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041578</manufacturerSrn>
    <authorisedRepresentativeName>BioDomi GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016611</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM0106</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:51:31.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974702710670</udiDi>
    <basicUdiDi>697470271PMA001H2</basicUdiDi>
    <tradeName>06974702710670</tradeName>
    <deviceName>Multi-pole Pulmonary Artery RF Ablation Catheter</deviceName>
    <manufacturerName>Pulnovo Medical (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041578</manufacturerSrn>
    <authorisedRepresentativeName>BioDomi GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016611</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM0104</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:51:25.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974702710663</udiDi>
    <basicUdiDi>697470271PMA001H2</basicUdiDi>
    <tradeName>06974702710663</tradeName>
    <deviceName>Multi-pole Pulmonary Artery RF Ablation Catheter</deviceName>
    <manufacturerName>Pulnovo Medical (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041578</manufacturerSrn>
    <authorisedRepresentativeName>BioDomi GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016611</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM0103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:51:24.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974702710656</udiDi>
    <basicUdiDi>697470271PMA001H2</basicUdiDi>
    <tradeName>06974702710656</tradeName>
    <deviceName>Multi-pole Pulmonary Artery RF Ablation Catheter</deviceName>
    <manufacturerName>Pulnovo Medical (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041578</manufacturerSrn>
    <authorisedRepresentativeName>BioDomi GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016611</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM0102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:51:23.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974702710649</udiDi>
    <basicUdiDi>697470271PMA001H2</basicUdiDi>
    <tradeName>06974702710649</tradeName>
    <deviceName>Multi-pole Pulmonary Artery RF Ablation Catheter</deviceName>
    <manufacturerName>Pulnovo Medical (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041578</manufacturerSrn>
    <authorisedRepresentativeName>BioDomi GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016611</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM0101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:51:21.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974702710076</udiDi>
    <basicUdiDi>697470271PMA001H2</basicUdiDi>
    <tradeName>06974702710076</tradeName>
    <deviceName>Multi-pole Pulmonary Artery RF Ablation Catheter</deviceName>
    <manufacturerName>Pulnovo Medical (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041578</manufacturerSrn>
    <authorisedRepresentativeName>BioDomi GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016611</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM0105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:51:15.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959582000233</udiDi>
    <basicUdiDi>B-06959582000233</basicUdiDi>
    <tradeName>Iberis</tradeName>
    <deviceName>Renal Denervation Systems</deviceName>
    <manufacturerName>Shanghai AngioCare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017311</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02030101</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD*ATCB160TC</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:57:39.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959582000226</udiDi>
    <basicUdiDi>B-06959582000226</basicUdiDi>
    <tradeName>Iberis</tradeName>
    <deviceName>Renal Denervation Systems</deviceName>
    <manufacturerName>Shanghai AngioCare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017311</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02030101</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD*ATCB090TC</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:57:33.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958289305610</udiDi>
    <basicUdiDi>B-06958289305610</basicUdiDi>
    <tradeName>06958289305610</tradeName>
    <deviceName>Plasma Radio Frequency Electrodes</deviceName>
    <manufacturerName>Shanghai Forerunner Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027294</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>FS C04-11</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:18:37.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958289305603</udiDi>
    <basicUdiDi>B-06958289305603</basicUdiDi>
    <tradeName>06958289305603</tradeName>
    <deviceName>Plasma Radio Frequency Electrodes</deviceName>
    <manufacturerName>Shanghai Forerunner Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027294</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>FS C04-10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:18:36.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958289305597</udiDi>
    <basicUdiDi>B-06958289305597</basicUdiDi>
    <tradeName>06958289305597</tradeName>
    <deviceName>Plasma Radio Frequency Electrodes</deviceName>
    <manufacturerName>Shanghai Forerunner Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027294</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>FS C04-9</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:18:35.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958289305580</udiDi>
    <basicUdiDi>B-06958289305580</basicUdiDi>
    <tradeName>06958289305580</tradeName>
    <deviceName>Plasma Radio Frequency Electrodes</deviceName>
    <manufacturerName>Shanghai Forerunner Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027294</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>FS C04-8</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:18:28.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958289305573</udiDi>
    <basicUdiDi>B-06958289305573</basicUdiDi>
    <tradeName>06958289305573</tradeName>
    <deviceName>Plasma Radio Frequency Electrodes</deviceName>
    <manufacturerName>Shanghai Forerunner Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027294</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>FS C04-7</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:18:27.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958289305566</udiDi>
    <basicUdiDi>B-06958289305566</basicUdiDi>
    <tradeName>06958289305566</tradeName>
    <deviceName>Plasma Radio Frequency Electrodes</deviceName>
    <manufacturerName>Shanghai Forerunner Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027294</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>FS C04-6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:18:25.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958289305542</udiDi>
    <basicUdiDi>B-06958289305542</basicUdiDi>
    <tradeName>06958289305542</tradeName>
    <deviceName>Plasma Radio Frequency Electrodes</deviceName>
    <manufacturerName>Shanghai Forerunner Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027294</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>FS C04-4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:18:24.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958289303135</udiDi>
    <basicUdiDi>B-06958289303135</basicUdiDi>
    <tradeName>Plasma Radio Frequency Electrodes</tradeName>
    <deviceName>Plasma Radio Frequency Electrodes</deviceName>
    <manufacturerName>Shanghai Forerunner Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027294</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>FS C07</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:16:43.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958289303128</udiDi>
    <basicUdiDi>B-06958289303128</basicUdiDi>
    <tradeName>06958289303128</tradeName>
    <deviceName>Plasma Radio Frequency Electrodes</deviceName>
    <manufacturerName>Shanghai Forerunner Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027294</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>FS C06</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:16:37.784Z</lastUpdated>
  </row>
</eudamedExport>