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Tokai Microcatheter, Carnelian NT

by Tokai Medical Products, Inc. 3 variants

Ref MXN135X-E, MXNS155X-E

Active European Union

CE MDR

Valid until

31 Mar 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberJP25/00000098 Date22 Sep 2025IssuedStatusActive expires 31 Mar 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • JP25/00000098 Active Amended

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    22 Sep 2025
    Expires
    31 Mar 2030
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Tokai Microcatheter
Model / Reference
MXN135X-E, MXNS155X-E
Primary DI / UDI-DI
04562382439848, 04562382439879
Basic UDI-DI
456238243MCTR
EMDN Code
C0104020101, C0104020202, C0104020205
Device Class
Class IIa
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
JP-MF-000011106
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Tokai Medical Products, Inc.

See all devices from Tokai Medical Products, Inc. →

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