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Radionuclide dose calibrator

by Comecer Netherlands B.V. Netherlands EUDAMEDGUDID

Ref 0202020161Model RDC-VIK-202 with IBC-Lite

Product code KPTEMDN Z11029005

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number2267926CE01 Date18 May 2026IssuedStatusActive expires 1 Feb 2028
United StatesGUDID listing GUDID Number08719324589017 UDI-DIDate6 Feb 2018ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

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 · GUDID · synced 22 Oct 2026

Trade Name
VIK203
Generic Name
Radioisotope calibration system
Device Name
Radionuclide dose calibrator
Model / Reference
RDC-VIK-202 with IBC-Lite EUDAMED
0202020161 EUDAMED
0202020091 GUDID
Primary DI / UDI-DI
08719324589017
Basic UDI-DI
8719324589RDCJU
Direct Marketing DI
08719324589017
FDA Product Code
KPT
EMDN Code
Z11029005 Automatic dose calibrators
GMDN Term
Radioisotope calibration system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.1360
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
RDC-VIK-202 with IBC-Lite
0202020161
GUDID
0202020091
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000026292

Other devices from Comecer Netherlands B.V.

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Serial Number
Other properties (22)
  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 4d016e7b-0612-413e-b778-fb9c0f4b5994 61 fields · synced 22 Oct 2026
  • FDA UDI 99f25515-945b-48c7-b96f-4465629d9d8a 34 fields · synced 24 May 2026