Identity
- Trade Name
- FARAPULSE PFA Capital Equipment EUDAMED
- Device Name
- FARAPULSE PFA Capital Equipment EUDAMED
- Model / Reference
- M004PFCE61M401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00191506042547 EUDAMED
- Basic UDI-DI
- 01915060000000000000536NE EUDAMED
- EMDN Code
- C020399 CARDIAC TISSUE ABLATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
FARAPULSE PFA Capital Equipment by Boston Scientific Corporation — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 01915060000000000000536NE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (1)
- EUDAMED 23dda8f2-fcbe-49b7-a871-cfa0129caca2 61 fields · synced Jun 18, 2026