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GluNEO Blood Glucose Test Strip

by OSANG Healthcare Co., Ltd South Korea EUDAMED

Ref INFS001A

EMDN W0101060101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08809115901811 Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

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 23 Oct 2026

Model / Reference
INFS001A
Primary DI / UDI-DI
08809115901811
Basic UDI-DI
B-08809115901811
EMDN Code
W0101060101 Glucose test strips
Device Class
Class IVD Annex II List B
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
  • Reagent
  • Self Testing
  • Surgical Instrument
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 06ae43fb-a456-4556-a09f-e6321159534c 61 fields · synced 23 Oct 2026