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nGEN

by Biosense Webster, Inc United States EUDAMED

Ref D138405Model nGEN Generator

EMDN Z12059011

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3903009CE01 Date1 Sep 2026IssuedStatusActive expires 1 Sep 2031

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3903009CE01 Reissued

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    1 Sep 2026
    Expires
    1 Sep 2031

Specification

EUDAMED · synced 22 Oct 2026

Device Name
nGEN Generator
Model / Reference
nGEN Generator, D138405
Primary DI / UDI-DI
10846835033175
Basic UDI-DI
08468350a0007F3
EMDN Code
Z12059011 Cardiac ablation equipment
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
US-MF-000014219
Authorised representative
Biosense Webster A Division of Johnson & Johnson Medical NV/SA BE-AR-000012231

Other devices from Biosense Webster Inc

See all devices from Biosense Webster Inc →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 5f3e9dca-0757-494e-860d-6f90f8a6cc78 61 fields · synced 22 Oct 2026