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IMMULITE 2000 Alpha-amylase (fungal) Specific Allergen

by Siemens Healthcare Diagnostics Products Ltd.

Ref 10385999Model IVDR_67_LLB_DUB-C_B_REAG_Alpha-amy (fungal) 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686900243UX Basic UDI-DI 00630414965727UDI-DIDate29 May 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  • Withdrawn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_Alpha-amy (fungal) Spfc Algn
Model / Reference
IVDR_67_LLB_DUB-C_B_REAG_Alpha-amy (fungal) Spfc Algn, 10385999
Primary DI / UDI-DI
00630414965727
Basic UDI-DI
0405686900243UX
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

Related devices

Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

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Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No