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CalproSmart Self-Test

by Calpro AS Norway EUDAMED

Ref CAL201

EMDN W0102160699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07090028592017 Basic UDI-DIDate26 Feb 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CAL201
Primary DI / UDI-DI
07090028592017
Basic UDI-DI
B-07090028592017
EMDN Code
W0102160699 Rheumatoid / inflammatory disease rt & poc - other
Device Class
Class IVD devices for self-testing
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
NO-MF-000036194

Other devices from Calpro AS

See all devices from Calpro AS →

Properties & raw data

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

Sources (1)

  • EUDAMED 39644f1e-d501-45a1-8cc3-1c49d680654f 61 fields · synced 22 Oct 2026