Identity
- Trade Name
- nGEN EUDAMED
- Device Name
- nGEN Generator EUDAMED
- Model / Reference
- nGEN Generator EUDAMEDD138403IL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10846835024425 EUDAMED
- Basic UDI-DI
- 08468350a0033F4 EUDAMED
- Direct Marketing DI
- 10846835024425 EUDAMED
- EMDN Code
- Z12059011 CARDIAC ABLATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
nGEN by Biosense Webster (israel) Ltd. — 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 | 08468350a0033F4 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biosense Webster (Israel) Ltd.
- EUDAMED SRN
- IL-MF-000017055
- Authorised Representative
- Biosense Webster A Division of Johnson & Johnson Medical NV/SA BE-AR-000012231
Sources (1)
- EUDAMED 10d17eed-7d21-4a6a-a089-bf8060e660f3 61 fields · synced Jun 19, 2026