Identity
- Trade Name
- Lumie Soleil EUDAMED
- Device Name
- Seasonal Affective Disorder (SAD) Light EUDAMED
- Model / Reference
- LBVE-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060006627316 EUDAMED
- Basic UDI-DI
- 506000662000002XR EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Category: Red-light phototherapy unit, professional
Lumie Soleil by Outside In (Cambridge) Ltd trading as Lumie — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Red-light phototherapy unit, professional.
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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 | 506000662000002XR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Outside In (Cambridge) Ltd trading as Lumie
- EUDAMED SRN
- GB-MF-000009152
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 9d35ef5f-a64b-46e9-a742-b6c60c772084 61 fields · synced Jul 18, 2026