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ImmuneCheck IgG

by PROTIA Inc. South Korea EUDAMED

Ref PHIG0212

EMDN W0102010105

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08809446480191 Basic UDI-DIDate29 Nov 2024RegisteredStatusActive

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

Device Name
ImmuneCheck IgG
Model / Reference
PHIG0212
Primary DI / UDI-DI
08809446480191
Basic UDI-DI
B-08809446480191
EMDN Code
W0102010105 Immunoglobulin g
Device Class
Class IVD General
Market of Registration
Greece

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
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED c502ba66-2b58-49ce-ac6c-db20c8ea5ce2 61 fields · synced 24 Oct 2026