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Lux HD 35 Detector

by Carestream Health, Inc. EUDAMED

Active European Union

Ref 6709828Model Lux HD 35

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08899710000217N Basic UDI-DIDate30 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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.

Specification

EUDAMED

Device Name
Digital Flat Panel Detectors
Model / Reference
Lux HD 35, 6709828
Primary DI / UDI-DI
60889976709825
Basic UDI-DI
08899710000217N
EMDN Code
Z11031180 Systems for direct digital radiology (dr) - hardware accessories
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000050774
Authorised representative
CARESTREAM HEALTH ITALIA S.R.L. IT-AR-000034890

Other devices from Carestream Health, Inc.

See all devices from Carestream Health, Inc. →

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