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    <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>
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    <udiDi>06974702710670</udiDi>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM0104</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:51:25.560Z</lastUpdated>
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    <udiDi>06974702710663</udiDi>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <udiDi>16972304751326</udiDi>
    <basicUdiDi>69723047500016P</basicUdiDi>
    <tradeName>RF Ablation Electrode Kits</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014087</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>SS-RFAS2-1007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:49:44.218Z</lastUpdated>
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    <udiDi>16972304751333</udiDi>
    <basicUdiDi>69723047500016P</basicUdiDi>
    <tradeName>RF Ablation Electrode Kits</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014087</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>SS-RFAS2-1010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:49:44.192Z</lastUpdated>
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    <udiDi>16972304751340</udiDi>
    <basicUdiDi>69723047500016P</basicUdiDi>
    <tradeName>RF Ablation Electrode Kits</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014087</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>SS-RFAS2-1530</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:49:44.161Z</lastUpdated>
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    <udiDi>16972304751357</udiDi>
    <basicUdiDi>69723047500016P</basicUdiDi>
    <tradeName>RF Ablation Electrode Kits</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014087</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>SS-RFAS1-1020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:49:44.133Z</lastUpdated>
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    <udiDi>16972304751364</udiDi>
    <basicUdiDi>69723047500016P</basicUdiDi>
    <tradeName>RF Ablation Electrode Kits</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014087</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>SS-RFAS1-1030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:49:44.112Z</lastUpdated>
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    <udiDi>16972304751371</udiDi>
    <basicUdiDi>69723047500016P</basicUdiDi>
    <tradeName>RF Ablation Electrode Kits</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014087</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>SS-RFAS1-1540</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:49:44.096Z</lastUpdated>
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    <udiDi>06936666528241</udiDi>
    <basicUdiDi>69366665CFH4</basicUdiDi>
    <tradeName>06936666528241</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFD 1.6-1-60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T16:59:18.141Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Zhejiang CuraWay Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025983</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFD 1.6-2-60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T16:59:15.735Z</lastUpdated>
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    <udiDi>06936666528227</udiDi>
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    <tradeName>06936666528227</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang CuraWay Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025983</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFD 1.6-3-60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T16:59:14.545Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Zhejiang CuraWay Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025983</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFD 1.6-5-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T16:59:13.347Z</lastUpdated>
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    <udiDi>06936666528203</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Zhejiang CuraWay Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025983</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFD 1.6-5-60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T16:59:12.122Z</lastUpdated>
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    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFD 1.6-7-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T16:59:09.733Z</lastUpdated>
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    <basicUdiDi>69366665CFH4</basicUdiDi>
    <tradeName>06936666528180</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFD 1.6-7-60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T16:59:08.534Z</lastUpdated>
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    <basicUdiDi>69366665CFH4</basicUdiDi>
    <tradeName>06936666528173</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFC 2.0-1-60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T16:59:07.335Z</lastUpdated>
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