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eCal

by Thermo Fisher Scientific Oy Finland EUDAMED

Ref 981830

EMDN W0101050301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6438153BU00054BQ Basic UDI-DIDate29 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
981830
Primary DI / UDI-DI
16438153818301
Basic UDI-DI
6438153BU00054BQ
Direct Marketing DI
16438153818301
EMDN Code
W0101050301 Calibrators multicomponent (cc)
Device Class
Class C
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000001479

Other devices from Thermo Fisher Scientific Oy

See all devices from Thermo Fisher Scientific Oy →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 1446c193-df28-46e6-9446-e9a66077300d 61 fields · synced 22 Oct 2026