Identity
- Trade Name
- ALE1WMEL EUDAMED
- Device Name
- Astralite EUDAMED
- Model / Reference
- ALE1WMEL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060928391807 EUDAMED
- Basic UDI-DI
- 506041344AL10X4 EUDAMED
- Direct Marketing DI
- 05060928391807 EUDAMED
- EMDN Code
- Z12010799 SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ale1wmel by Brandon Medical Company Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506041344AL10X4 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brandon Medical Company Limited
- EUDAMED SRN
- GB-MF-000005501
- Authorised Representative
- RegTrac Limited IE-AR-000042448
Sources (1)
- EUDAMED 5eeb792e-d2d8-414e-af18-0cc20623227a 61 fields · synced Jun 19, 2026