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GluNEO Lite Blood Glucose Test Strip

by OSANG Healthcare Co., Ltd 8 variants

Ref INFCN001L

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08809115907288 Basic UDI-DI 08809115907288UDI-DIDate12 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
GluNEO Lite Blood Glucose Test Strip - INFCN001L
Model / Reference
INFCN001L
Primary DI / UDI-DI
08809115907288
Basic UDI-DI
B-08809115907288
EMDN Code
W0101060101 Glucose test strips
Device Class
Class IVD Annex II List B
EU market of registration
Germany

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

  • Reagent
  • Self Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No