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Glucocard W (Gt-7210)

by ARKRAY Factory, Inc. 12 variants

Ref 100818

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-100818LX Basic UDI-DI D-100818LXUDI-DIDate7 Nov 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
100818
Primary DI / UDI-DI
D-100818LX
Basic UDI-DI
B-100818LX
EMDN Code
W0101060101, W0201060102
Device Class
Class IVD Annex II List B
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
JP-MF-000003008
Authorised representative
ARKRAY Europe, B.V. NL-AR-000002056

Other devices from ARKRAY Factory, Inc.

See all devices from ARKRAY Factory, Inc. →

Properties

  • 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