Identity
- Trade Name
- ILab Aries with ISE EUDAMED
- Device Name
- ILab Aries with ISE EUDAMED
- Model / Reference
- 000160258304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426950491019 EUDAMED
- Basic UDI-DI
- 84269504910198D EUDAMED
- Direct Marketing DI
- 08426950491019 EUDAMED
- EMDN Code
- W0201010105 CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
ILab Aries with ISE by Instrumentation Laboratory SpA — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 84269504910198D | Class A | Active |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory SpA
- EUDAMED SRN
- IT-MF-000009277
Sources (1)
- EUDAMED 0e73ec2b-793f-44e0-81d7-705bb3533072 61 fields · synced Jun 19, 2026