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Lineblot Ige US9

by Gold Standard Diagnostics Kassel GmbH Germany EUDAMED

Ref ILE-LBL41 EMDN W01020205

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ILE-LBL417A Basic UDI-DIDate11 Jun 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  • Withdrawn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
Lineblot Ige US9
Model / Reference
ILE-LBL41
Primary DI / UDI-DI
ILE-LBL417A
Basic UDI-DI
B-ILE-LBL417A
EMDN Code
W01020205 Immunoglobulin e - screen
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
  • Animal Tissues
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED c47d1e79-ed73-4d44-aa2e-301e7ab0a658 61 fields · synced 22 Oct 2026