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IMMULITE 2000 Food Panel 4 Specific Allergen

by Siemens Healthcare Diagnostics Products Ltd. FDA registration: Germany EUDAMED

Ref 10635711Model IVDR_67_LLB_DUB-C_C_REAG_Food Panel 4 Specific Allergen EMDN W01020203

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686900405UZ Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
IVDR_67_LLB_DUB-C_C_REAG_Food Panel 4 Specific Allergen
Model / Reference
IVDR_67_LLB_DUB-C_C_REAG_Food Panel 4 Specific Allergen, 10635711
Primary DI / UDI-DI
00630414986234
Basic UDI-DI
0405686900405UZ
EMDN Code
W01020203 Immunoglobulin e - monotest/monoresult - multi ag
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000016339
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

Other devices from Siemens Healthcare Diagnostics Products Limited

See all devices from Siemens Healthcare Diagnostics Products Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED ee87d40e-7c42-4770-b7ef-e1adb4548202 61 fields · synced 23 Oct 2026