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ISE Serum Standard Set (NA)

by JEOL Ltd. MF Japan EUDAMED

Ref 781617995 EMDN W0101070302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4987762B04900KK Basic UDI-DIDate13 Mar 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
BM Family
Model / Reference
781617995
Primary DI / UDI-DI
04987762130946
Basic UDI-DI
4987762B04900KK
EMDN Code
W0101070302 Electrolyte electrode buffers and solutions
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000026608
Authorised representative
JEOL(Europe)BV AR NL-AR-000023086

Other devices from JEOL Ltd. MF

See all devices from JEOL Ltd. MF →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 29e3c177-bbbc-4cb6-ac34-b4c39a46fffa 61 fields · synced 22 Oct 2026