Identity
- Trade Name
- Solas OR XL EUDAMED
- Device Name
- Solas OR XL EUDAMED
- Model / Reference
- A4120XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50605088200868 EUDAMED
- Basic UDI-DI
- 50605088204120XL9F EUDAMED
- Direct Marketing DI
- 50605088200868 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland 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
Solas OR XL by Cirdan Imaging Ltd — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213691 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 50605088204120XL9F | Class A | Active |
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Manufacturer
- Manufacturer
- Cirdan Imaging Ltd
- EUDAMED SRN
- XI-MF-000018019
Sources (2)
- EUDAMED 9a94cd8c-f3f0-4dff-96ce-e2d98bb846b8 61 fields · synced Jul 9, 2026
- FDA 510(k) K213691 1 fields · synced May 18, 2026