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GluNEO H Link Blood Glucose/Blood β-Ketone Test Meter (Full Set)

by OSANG Healthcare Co., Ltd 2 variants

Ref OG-PH05-HL-2Model OG-PH05-HLM

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880911590OGPH05HLMG9 Basic UDI-DI 08800323056188UDI-DIDate3 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
GluNEO H Link Blood Glucose/Blood β-Ketone Test Meter
Model / Reference
OG-PH05-HLM, OG-PH05-HL-2
Primary DI / UDI-DI
08800323056188
Basic UDI-DI
880911590OGPH05HLMG9
Direct Marketing DI
08800323056188
EMDN Code
W020106019099 Various diabetes monitoring instruments - other
Device Class
Class A
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

  • 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