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CARTBox-Suite Light

by CART-Tech B.V. EUDAMED

Active European Union

Ref CBSL 1.x

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number87202991852CARTBox2S Basic UDI-DIDate2 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2259206CE01 Amended

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    10 Feb 2025
    Expires
    30 Jan 2028
    Reason
    Mnf data change

Specification

EUDAMED

Device Name
CARTBox-Suite Light
Model / Reference
CBSL 1.x
Primary DI / UDI-DI
08720299185210
Basic UDI-DI
87202991852CARTBox2S
Direct Marketing DI
08720299185210
EMDN Code
Z12011482 Surgical navigation instruments - software accessories
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000003958

Properties

Other properties (13)

  • Sterile: No
  • 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