Skip to content

Spotchem Ii Cpk

by ARKRAY Factory, Inc. Japan EUDAMED

Ref 77172

EMDN W01010113

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-77172JA Basic UDI-DIDate29 Apr 2022RegisteredStatusActive

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 25 Oct 2026

Model / Reference
77172
Primary DI / UDI-DI
D-77172JA
Basic UDI-DI
B-77172JA
EMDN Code
W01010113 Creatine kinase - total
Device Class
Class IVD General
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
JP-MF-000003008
Authorised representative
ARKRAY Europe, B.V. NL-AR-000002056

Other devices from ARKRAY Factory, Inc.

See all devices from ARKRAY Factory, Inc. →

Properties & raw data

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

Sources (1)

  • EUDAMED dacbeab9-fc86-48de-983e-92ec1b8cf601 61 fields · synced 25 Oct 2026