Lumipulse pTau 217 Plasma Controls <2x2C, CE>

by Fujirebio Europe N.V. Belgium EUDAMED

Ref 81546 EMDN W0102152003

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number54144700375H Basic UDI-DI	Date25 Aug 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Withdrawn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 25 Oct 2026

Device Name: Lumipulse pTau 217 Plasma Controls
Model / Reference: 81546

Primary DI / UDI-DI: 05414470815463
Basic UDI-DI: 54144700375H
EMDN Code: W0102152003 Specific protein controls

Device Class: Class B
Market of Registration: Belgium

Manufacturer details

EUDAMED SRN: BE-MF-000001792

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Properties & raw data

Show properties, registry sources and raw records

Animal Tissues
Reagent
Professional Testing

Other properties (8)

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

Sources (1)

EUDAMED e3f582eb-85f3-42d0-9415-3298ad217661 61 fields · synced 25 Oct 2026