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LuX-Valve Plus

by Jenscare Scientific (Netherlands) B.V. Netherlands EUDAMED

Ref JS/SID01-33-100

EMDN C0501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2293668CE01 Date7 Jul 2026IssuedStatusActive expires 1 Jul 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2293668CE01 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    7 Jul 2026
    Expires
    1 Jul 2030

Specification

EUDAMED · synced 22 Oct 2026

Device Name
LuX-Valve Plus Introducer Kit
Model / Reference
JS/SID01-33-100
Primary DI / UDI-DI
08720876800499
Basic UDI-DI
87208768lux04JQ
EMDN Code
C0501 Cardiovascular introducer sheaths, non-valved
Device Class
Class IIa
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
NL-MF-000040717

Other devices from Jenscare Scientific (Netherlands) B.V.

  • LuX-Valve Plus

    Class III

  • LuX Valve Plus

    Class III

  • LuX-Valve Plus

    Class III

  • LuX-Valve Plus

    Class I

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 954827ee-0b85-4e62-bece-dc20615fd261 61 fields · synced 22 Oct 2026