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Najuta Thoracic Stent Graft System

by Sb-Kawasumi Laboratories, Inc. 2 variants

Ref AR8L-S42CL2-3U95

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04987488107659 Basic UDI-DI 04987488107659UDI-DIDate26 Jun 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  • Withdrawn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

Model / Reference
AR8L-S42CL2-3U95
Primary DI / UDI-DI
04987488107659
Basic UDI-DI
B-04987488107659
EMDN Code
P07040199 Vascular endoprostheses - other
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
JP-MF-000011253
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

Other devices from Sb-Kawasumi Laboratories, Inc.

See all devices from Sb-Kawasumi Laboratories, Inc. →

Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No