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Radifocus Introducer Ii

by Terumo Medical Corporation EUDAMED

Active European Union

Ref RS*B70N10MRD

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00389701005386 Basic UDI-DIDate17 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Introducer Kit
Model / Reference
RS*B70N10MRD
Primary DI / UDI-DI
00389701005386
Basic UDI-DI
B-00389701005386
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000026109
Authorised representative
TERUMO EUROPE N.V. BE-AR-000001433

Other devices from Terumo Medical Corporation

See all devices from Terumo Medical Corporation →

Properties

  • 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