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RADIFOCUS INTRODUCER II with R/O MARKER

by Terumo Medical Corporation 29 variants

Ref RB*C6SN10NC

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00389701005539 Basic UDI-DI 00389701005539UDI-DIDate17 Sep 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Introducer Kit
Model / Reference
RB*C6SN10NC
Primary DI / UDI-DI
00389701005539
Basic UDI-DI
B-00389701005539
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
Device Class
Class IIa
EU 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