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Webster Electrophysiology Catheter

by Biosense Webster, Inc United States EUDAMED

Ref 37U00R

EMDN C020199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-USMF000014219000010Q7 Basic UDI-DIDate20 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
37U00R
Primary DI / UDI-DI
D-USMF000014219000010Q7
Basic UDI-DI
B-USMF000014219000010Q7
EMDN Code
C020199 Cardiac electrophysiology and mapping devices - other
Device Class
Class III
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
  • Sterile
Other properties (12)
  • 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 b28853fa-7a2a-448e-ab13-130f5e219d19 61 fields · synced 22 Oct 2026