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IMMULITE 2000 Rubella IgM

by Siemens Healthcare Diagnostics Products Ltd.

Ref 10381327Model IVDR_67_LLB_DUB-C_C_KIT_Rubella IgM

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901461VJ Basic UDI-DI 00630414961996UDI-DIDate11 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
IVDR_67_LLB_DUB-C_C_KIT_Rubella IgM
Model / Reference
IVDR_67_LLB_DUB-C_C_KIT_Rubella IgM, 10381327
Primary DI / UDI-DI
00630414961996
Basic UDI-DI
0405686901461VJ
EMDN Code
W0105040103 Rubella virus igm
Device Class
Class C
EU market of registration
Germany

Manufacturer details

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

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Properties

  • 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