Skip to content

Standard solution 1

by Jokoh Co., Ltd. Japan EUDAMED

Ref J11034Model EX-Ca

EMDN W0101050301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-04980679110346 Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Standard solution 1
Model / Reference
EX-Ca, J11034
Primary DI / UDI-DI
04980679110346
Basic UDI-DI
B-04980679110346
EMDN Code
W0101050301 Calibrators multicomponent (cc)
Device Class
Class IVD General
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
JP-MF-000025161
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Jokoh Co., Ltd.

See all devices from Jokoh Co., Ltd. →

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 945649f7-d0d5-4910-8212-2d60a338b8be 61 fields · synced 22 Oct 2026