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nGEN Pump

by Biosense Webster, Inc United States EUDAMED

Ref D139701Model nGEN Pump

EMDN Z12030301

Regulatory status

as of 25 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 24 Oct 2026

Model / Reference
nGEN Pump, D139701
Primary DI / UDI-DI
10846835017458
Basic UDI-DI
08453840a0014CW
Direct Marketing DI
10846835017458
EMDN Code
Z12030301 Infusion pumps
Device Class
Class IIa
Market of Registration
Belgium

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
Other properties (13)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED e3288ef6-8f81-45de-b56d-0729196311a8 61 fields · synced 24 Oct 2026