Identity
- Trade Name
- FIX-RAL 555 EUDAMED
- Device Name
- FIX-RAL 555 EUDAMED
- Model / Reference
- 362870-0100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760177193482 EUDAMED
- Basic UDI-DI
- 376017719362870LL EUDAMED
- EMDN Code
- W0103010399 HAEMATOLOGY STAINS FOR MICROSCOPY - OTHER 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Fix-Ral 555 by RAL Diagnostics — 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 | 376017719362870LL | Class A | Active |
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Manufacturer
- Manufacturer
- RAL Diagnostics
- EUDAMED SRN
- FR-MF-000007902
Sources (1)
- EUDAMED 70c08cfb-8d18-4c53-984c-a6ce2ed69339 61 fields · synced Sep 30, 2026