Identity
- Device Name
- AQUAREL EUDAMED
- Model / Reference
- AQ2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05419980256126 EUDAMED
- Basic UDI-DI
- 54199802561AQ9Y EUDAMED
- Direct Marketing DI
- 05419980256126 EUDAMED
- EMDN Code
- W02060101 AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Aquarel by Sidena — 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 | 54199802561AQ9Y | Class A | Active |
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Manufacturer
- Manufacturer
- Sidena
- EUDAMED SRN
- FR-MF-000021700
Sources (1)
- EUDAMED 65c18c72-7032-4cf0-b277-9e43a4fcd659 61 fields · synced Jun 18, 2026