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Standard Gas

by Otsuka Electronics Co., Ltd. Japan EUDAMED

Ref UB-SP-012

EMDN W0105080899

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number498703502SG460644FU Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
UB-SP-012
Primary DI / UDI-DI
04987035485513
Basic UDI-DI
498703502SG460644FU
EMDN Code
W0105080899 Controls - inf. immunology - other
Device Class
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
JP-MF-000001943
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Otsuka Electronics Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 7c7409a9-ba87-4a5b-8ff2-3a4267193c8e 61 fields · synced 22 Oct 2026