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Basic Screen IGG4

by Gold Standard Diagnostics Kassel GmbH Germany EUDAMED

Ref ILE-SCG03

EMDN W01020208

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ILE-SCG038V Basic UDI-DIDate21 Nov 2023RegisteredStatusActive

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 22 Oct 2026

Device Name
Basic Screen IGG4
Model / Reference
ILE-SCG03
Primary DI / UDI-DI
D-ILE-SCG038V
Basic UDI-DI
B-ILE-SCG038V
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 4adc4d29-36b3-4f8b-b64a-99fe8ce90313 61 fields · synced 22 Oct 2026