Multi-pole Pulmonary Artery RF Ablation Catheter
by Pulnovo Medical (Wuxi) Co., Ltd. China EUDAMED
Ref PM0101Model PADN30C10120, PADN35C10120, PADN37C10120, PADN40C10120, PADN45C10120, PADN50C10120 EMDN K02030199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697470271PMA001H2 | Date3 Sep 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 6158488CE01 Issued
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 19 May 2025
- Expires
- 1 Mar 2030
- 6158488TD01 Issued
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 19 Mar 2025
- Expires
- 1 Mar 2030
Specification
- Device Name
- Multi-pole Pulmonary Artery RF Ablation Catheter
- Model / Reference
- PADN30C10120, PADN35C10120, PADN37C10120, PADN40C10120, PADN45C10120, PADN50C10120, PM0101
- Primary DI / UDI-DI
- 06974702710649
- Basic UDI-DI
- 697470271PMA001H2
- Direct Marketing DI
- 06974702710649
- EMDN Code
- K02030199 Radiofrequency surgery instruments, single-use - other
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000041578
- Authorised representative
- BioDomi GmbH DE-AR-000016611
Other devices from Pulnovo Medical (Wuxi) Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 469e7506-fae7-478b-ab12-c677f8efefff