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Radionuclide dose calibrator

by Comecer Netherlands B.V. Netherlands EUDAMED

Ref 0202020088Model RDC-VIK-202 with IBC-Lite

EMDN Z11029005

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2267926CE01 Date18 May 2026IssuedStatusActive expires 1 Feb 2028

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2267926CE01 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    18 May 2026
    Expires
    1 Feb 2028
    Reason
    Add device or group

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Radionuclide dose calibrator
Model / Reference
RDC-VIK-202 with IBC-Lite, 0202020088
Primary DI / UDI-DI
08719324589079
Basic UDI-DI
8719324589RDCJU
Direct Marketing DI
08719324589079
EMDN Code
Z11029005 Automatic dose calibrators
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
NL-MF-000026292

Other devices from Comecer Netherlands B.V.

See all devices from Comecer Netherlands B.V. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED a7e5567f-3111-4801-a193-9728a1481210 61 fields · synced 25 Oct 2026