Skip to content

IgG4 Screen Nutritional K44 ELISA

by Gold Standard Diagnostics Kassel GmbH Germany EUDAMED

Ref ILE-SCG232 EMDN W01020208

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ILE-SCG2323S Basic UDI-DIDate27 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
IgG4 Screen Nutritional K44 ELISA
Model / Reference
ILE-SCG232
Primary DI / UDI-DI
ILE-SCG2323S
Basic UDI-DI
B-ILE-SCG2323S
EMDN Code
W01020208 Allergene specific igg
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000021646

Other devices from Gold Standard Diagnostics Kassel GmbH

See all devices from Gold Standard Diagnostics Kassel GmbH →

Properties & raw data

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

Sources (1)

  • EUDAMED 358e30d0-e0e7-40eb-a1d4-d8dd36241eff 61 fields · synced 22 Oct 2026