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Gmate® Plus Blood Glucose Test Strip

by GB Lifecare Co., Ltd. EUDAMED

Active European Union

Ref PS-003-25-2Model PS-003

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880930116PS003AX Basic UDI-DIDate29 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Model / Reference
PS-003, PS-003-25-2
Primary DI / UDI-DI
08809301168363
Basic UDI-DI
880930116PS003AX
EMDN Code
W0101060101 Glucose test strips
Device Class
Class C
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
KR-MF-000039508
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Self Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No