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Immulite 2000 Psa

by Siemens Healthcare Diagnostics Products Ltd. United States EUDAMED

Ref 10380986Model IVDR_67_LLB_DUB-C_C_REAG_KIT_PSA

EMDN W0102030113

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901460VG Basic UDI-DIDate1 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
IVDR_67_LLB_DUB-C_c_reag_kit_psa
Model / Reference
IVDR_67_LLB_DUB-C_C_REAG_KIT_PSA, 10380986
Primary DI / UDI-DI
00630414961958
Basic UDI-DI
0405686901460VG
EMDN Code
W0102030113 Total prostatic specific antigen
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
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 90cc91bb-50b6-481e-a8bf-cdcc95b7a74d 61 fields · synced 24 Oct 2026