Identity
- Trade Name
- Solas OR EUDAMED
- Device Name
- Solas OR EUDAMED
- Model / Reference
- A4120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50605088200622 EUDAMED
- Basic UDI-DI
- 506050882A4120PA EUDAMED
- Direct Marketing DI
- 50605088200622 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 by Cirdan Imaging Ltd — 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 | 506050882A4120PA | Class A | Active |
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Manufacturer
- Manufacturer
- Cirdan Imaging Ltd
- EUDAMED SRN
- XI-MF-000018019
Sources (1)
- EUDAMED bbbed809-5768-4681-9c6b-62a75769bd84 61 fields · synced Jun 19, 2026