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GlucoNavii® App

by SD Biosensor Inc. United States EUDAMED

Ref 01APP10Model G-APP-01

EMDN W0201010182

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88001117IAAA01PA16LB Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
G-APP-01, 01APP10
Primary DI / UDI-DI
08800111724800
Basic UDI-DI
88001117IAAA01PA16LB
Direct Marketing DI
08800111724800
EMDN Code
W0201010182 Chemistry analysers - software accessories
Device Class
Class A
Special Device Type
Software
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
KR-MF-000009168
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Sd Biosensor, Inc.

See all devices from Sd Biosensor, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Self Testing
  • Near-Patient Testing
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 93aced5d-3cec-46a4-8dad-b296bdaecba2 61 fields · synced 24 Oct 2026