Identity
- Trade Name
- Smartcolor EUDAMED
- Device Name
- AQUAREL-1P EUDAMED
- Model / Reference
- AQUAREL-502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05419980256140 EUDAMED
- Basic UDI-DI
- 54199802561AQ1PZA EUDAMED
- Direct Marketing DI
- 05419980256140 EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS 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
Yes
EUDAMED
Category: Microscope slide stainer IVD
Smartcolor by Sidena — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 54199802561AQ1PZA | Class A | Active |
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Manufacturer
- Manufacturer
- Sidena
- EUDAMED SRN
- FR-MF-000021700
Sources (1)
- EUDAMED 52c511c0-9a8f-4f1a-8e91-20c769d5ca5b 61 fields · synced Jul 23, 2026