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CLOVER A1c Expert Analyzer

by OSANG Healthcare Co., Ltd South Korea EUDAMED

Ref OHHS03AModel IHM-0005M EMDN W0201060101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880911590IHM0005MM5 Basic UDI-DIDate9 Jun 2026RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Model / Reference
IHM-0005M, OHHS03A
Primary DI / UDI-DI
08809115900357, 08809115900494, 08800323058496
Basic UDI-DI
880911590IHM0005MM5
Direct Marketing DI
08809115900357
08809115900494
08800323058496
EMDN Code
W0201060101 Glycosilated hemoglobin devices
Device Class
Class A
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
KR-MF-000032605
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from OSANG HEALTHCARE Co., Ltd.

See all devices from OSANG HEALTHCARE Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
  • New Device
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No

Sources (3)

  • EUDAMED b2958b39-5351-4127-a138-bc555da557eb 61 fields · synced 24 Oct 2026
  • EUDAMED 08809115900494|880911590IHM0005MM5 61 fields · synced 11 Jul 2026
  • EUDAMED 08800323058496|880911590IHM0005MM5 61 fields · synced 14 Jul 2026