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Erythrocyte Sedimentation Rate Analyzer

by Jokoh Co., Ltd. Japan EUDAMED

Ref J06460, J06462Model Smart Rate 10, Smart Rate 40 EMDN W02029001

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04980679064601 Basic UDI-DIDate24 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Erythrocyte Sedimentation Rate Analyzer
Model / Reference
Smart Rate 10, J06460, Smart Rate 40, J06462
Primary DI / UDI-DI
04980679064601, 04980679064625
Basic UDI-DI
B-04980679064601, B-04980679064625
EMDN Code
W02029001 Erythrocyte sedimentation rate devices
Device Class
Class IVD General
Market of Registration
Lithuania
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
  • Near-Patient Testing YesEUDAMEDNoEUDAMED
  • Professional Testing
  • Surgical Instrument
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No

Sources (2)

  • EUDAMED f671fbb6-508c-41f7-bf95-bd1b322d355d 61 fields · synced 24 Oct 2026
  • EUDAMED 04980679064625|B-04980679064625 61 fields · synced 9 Jul 2026