Identity
- Device Name
- HISCL β-Amyloid 1-40 Assay kit EUDAMED
- Model / Reference
- BV419142 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-BV4191423U EUDAMED
- Basic UDI-DI
- B-BV4191423U EUDAMED
- EMDN Code
- W0102019013 BETA-AMYLOID (1-40) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HISCL β-Amyloid 1-40 Assay kit by Sysmex Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-BV4191423U | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (1)
- EUDAMED 67bced2c-bc38-496c-8cee-ecaf31d73dbc 61 fields · synced Jul 12, 2026