IMMULITE 2000 Toxoplasma IgM (µ-Capture)

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

Ref 10381298Model IVDR_67_LLB_DUB-C_C_KIT_Toxoplasma IgM EMDN W0105050103

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number0405686901465VS Basic UDI-DI	Date1 Jun 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: IVDR_67_LLB_DUB-C_C_KIT_Toxoplasma IgM
Model / Reference: IVDR_67_LLB_DUB-C_C_KIT_Toxoplasma IgM, 10381298

Primary DI / UDI-DI: 00630414972893
Basic UDI-DI: 0405686901465VS
EMDN Code: W0105050103 Toxoplasma antibody igm

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

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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 7ec829e0-8624-4722-b1cb-f3c94da2c61c 61 fields · synced 22 Oct 2026