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IMMULITE 2000 Tetrachlorophthalic Anhydride TCPA Specific Allergen

by Siemens Healthcare Diagnostics Products Ltd.

Ref 10385982Model IVDR_67_LLB_DUB-C_B_REAG_Tetrachloro. Anhydrd Spfc Algn

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686900669W5 Basic UDI-DI 00630414996011UDI-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  • Withdrawn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_B_REAG_Tetrachloro. Anhydrd Spfc Algn
Model / Reference
IVDR_67_LLB_DUB-C_B_REAG_Tetrachloro. Anhydrd Spfc Algn, 10385982
Primary DI / UDI-DI
00630414996011
Basic UDI-DI
0405686900669W5
EMDN Code
W01020202 Immunoglobulin e - specific, monotest/monoresult
Device Class
Class B
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
  • 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