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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

nGEN

UDI-DI 10846835016109Basic UDI-DI 08468350a0007F3

Class IIb · MDR · Biosense Webster, Inc

Identification
Model
nGEN Generator
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
Yes
Reusable surgical
No
Certificates

3903009CE01

EU quality management system · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-09-01 · Expiry 2031-09-01

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Biosense Webster, Inc

SRN US-MF-000014219

US · Irvine, California

manufacturer

Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA (BE-AR-000012231)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ngen-6109 · UDI page: /udi/10846835016109

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