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Multi-pole Pulmonary Artery RF Ablation Generator
EUDAMEDClass IIb (EU MDR)
Ref PM1001Model PHD360
Identity
- Device Name
- Multi-pole Pulmonary Artery RF Ablation Generator EUDAMED
- Model / Reference
- PHD360 EUDAMEDPM1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974702710694 EUDAMED
- Basic UDI-DI
- 697470271PMA002H4 EUDAMED
- Direct Marketing DI
- 06974702710694 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Foot-switch, electrical
Multi-pole Pulmonary Artery RF Ablation Generator by Pulnovo Medical (Wuxi) Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697470271PMA002H4 | Class IIb | 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 8041061d-5507-4edd-8e02-86c557146b8c 61 fields · synced Jun 18, 2026