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ALIB012E

by Sugentech, Inc. South Korea EUDAMED

Ref ALIB012EModel SGTi-Allergy Screen Inhalant Panel

EMDN W01020205

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08809408863154 Basic UDI-DIDate27 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
SGTi-Allergy Screen Inhalant Panel, ALIB012E
Primary DI / UDI-DI
08809408863154
Basic UDI-DI
B-08809408863154
EMDN Code
W01020205 Immunoglobulin e - screen
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000023952
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Sugentech, Inc.

See all devices from Sugentech, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 08809408863154|B-08809408863154 61 fields · synced 24 Oct 2026