Identity
- Device Name
- ST AIA-PACK Presepsin EUDAMEDST AIA-PACK Presepsin SAMPLE DILUTING SOLUTION EUDAMED
- Model / Reference
- 0025242 EUDAMED0025542 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14560189213514 EUDAMED04560189213531 EUDAMED
- Basic UDI-DI
- B-14560189213514 EUDAMEDB-04560189213531 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
ST AIA-PACK Presepsin by Tosoh 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-14560189213514 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (2)
- EUDAMED 5462917b-85f7-4e13-aecd-30198c3dddfe 61 fields · synced Jul 31, 2026
- EUDAMED cd315679-1ac4-42da-9184-f2051c695b19 61 fields · synced May 18, 2026