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PROTIA Allergy-Q 64S Panel

by PROTIA Inc. South Korea EUDAMED

Ref PALX0312Model PROTIA Allergy-Q 64S Panel EMDN W01020204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number880944648ALX03KH Basic UDI-DIDate2 Aug 2024RegisteredStatusActive
European UnionCE/IVDR Number880944648ALX03KH Basic UDI-DIDate2 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
PROTIA Allergy-Q
Model / Reference
PROTIA Allergy-Q 64S Panel, PALX0312
Primary DI / UDI-DI
08809446480108
Basic UDI-DI
880944648ALX03KH, B-08809446480108
Direct Marketing DI
08809446480108
EMDN Code
W01020204 Immunoglobulin e - monotest/pluriresult-multi ag
Device Class
Class C
Class IVD General
Market of Registration
Türkiye
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000026040
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from PROTIA Inc.

See all devices from PROTIA Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Microbial Substances NoEUDAMEDYesEUDAMED
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED b310f18a-b678-431f-8d8b-79adfba66f29 61 fields · synced 22 Oct 2026
  • EUDAMED 08809446480108|B-08809446480108 61 fields · synced 24 Oct 2026