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IMMULITE 2000 rApi m 1 Specific Allergen

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

Ref 10368595Model IVDR_67_LLB_DUB-C_C_REAG_rApi m 1 Specific Allergen EMDN W01020202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686900607VF Basic UDI-DIDate10 Aug 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  • Withdrawn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 25 Oct 2026

Device Name
IVDR_67_LLB_DUB-C_C_REAG_rApi m 1 Specific Allergen
Model / Reference
IVDR_67_LLB_DUB-C_C_REAG_rApi m 1 Specific Allergen, 10368595
Primary DI / UDI-DI
00630414594002
Basic UDI-DI
0405686900607VF
EMDN Code
W01020202 Immunoglobulin e - specific, monotest/monoresult
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
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 00630414594002|0405686900607VF 61 fields · synced 25 Oct 2026