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SDB HbA1c Control

by SD Biosensor Inc. South Korea EUDAMED

Ref 10A1CC20Model C-A1C EMDN W0102160801

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88001117IPCA02FA05WA Basic UDI-DIDate29 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
C-A1C, 10A1CC20
Primary DI / UDI-DI
08800111725678
Basic UDI-DI
88001117IPCA02FA05WA
EMDN Code
W0102160801 Controls immunochem - rt & poc
Device Class
Class C
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000009168
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Sd Biosensor

See all devices from Sd Biosensor →

Properties & raw data

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

Sources (1)

  • EUDAMED 08800111725678|88001117IPCA02FA05WA 61 fields · synced 25 Oct 2026