Skip to content

BM Test HbA1c Calibrator

by JEOL Ltd. MF Japan EUDAMED

Ref 780609981

EMDN W01010214

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-780609981T6 Basic UDI-DIDate3 Jul 2023RegisteredStatusActive

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
780609981
Primary DI / UDI-DI
D-780609981T6
Basic UDI-DI
B-780609981T6
EMDN Code
W01010214 Glycosylated/glycated haemoglobin (cc)
Device Class
Class IVD General
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
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED ed517e82-4b9e-4b89-8011-023a9b0942a6 61 fields · synced 22 Oct 2026