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Multi-pole Pulmonary Artery RF Ablation Catheter
EUDAMEDClass III (EU MDR)
Ref PM0105Model PADN30C10120, PADN35C10120, PADN37C10120, PADN40C10120, PADN45C10120, PADN50C10120
Identity
- Device Name
- Multi-pole Pulmonary Artery RF Ablation Catheter EUDAMED
- Model / Reference
- PADN30C10120, PADN35C10120, PADN37C10120, PADN40C10120, PADN45C10120, PADN50C10120 EUDAMEDPM0105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974702710076 EUDAMED
- Basic UDI-DI
- 697470271PMA001H2 EUDAMED
- Direct Marketing DI
- 06974702710076 EUDAMED
- EMDN Code
- K02030199 RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Microwave ablation system probe, non-powered
Multi-pole Pulmonary Artery RF Ablation Catheter by Pulnovo Medical (Wuxi) Co., Ltd. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Microwave ablation system probe, non-powered.
- Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
- TempSure System, Surgical — Cynosure, LLC · Class IIb
- Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
- SURGITRON 4.0 DUAL RF/90 IEC 220-240V — Cynosure, LLC · Class IIb
- Swift® — Emblation , Ltd. · Class I
- Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
- Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
- Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697470271PMA001H2 | Class III | Active |
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Manufacturer
- Manufacturer
- Pulnovo Medical (Wuxi) Co., Ltd.
- EUDAMED SRN
- CN-MF-000041578
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (1)
- EUDAMED d8d77857-74b3-463c-a427-57eb90706010 61 fields · synced Jun 18, 2026