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HBA1C 2R Cal Set

by Erba Lachema s.r.o. Czech Republic EUDAMED

Ref XSYS0097

EMDN W0102152299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8592156ICCAL109V8 Basic UDI-DIDate7 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
HbA1c 2R CALIBRATOR SET
Model / Reference
XSYS0097
Primary DI / UDI-DI
08592156151702
Basic UDI-DI
8592156ICCAL109V8
EMDN Code
W0102152299 Standards and calibrators - immunochemistry - other
Device Class
Class C
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000024067

Other devices from Erba Lachema s.r.o.

See all devices from Erba Lachema s.r.o. →

Properties & raw data

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

Sources (1)

  • EUDAMED 08592156151702|8592156ICCAL109V8 61 fields · synced 23 Oct 2026