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Dandy Chairside

by Zima International, Inc. EUDAMED

Active European Union

Ref CSSOFTWARE

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081020609CHAIRSIDENZ Basic UDI-DIDate28 Sep 2026RegisteredStatusActive

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  • Withdrawn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)
  • SCAR-27.2.1.0 Issued

    Quality management system EU MDR

    Notified body
    Notified body 3022
    Issued
    30 Sep 2026
    Expires
    29 Sep 2031

Specification

EUDAMED

Device Name
Dandy Chairside
Model / Reference
CSSOFTWARE
Primary DI / UDI-DI
00810206091326
Basic UDI-DI
081020609CHAIRSIDENZ
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000056952
Authorised representative
Dandy Labs Europe FR-AR-000055442

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