Identity
- Trade Name
- Bodyclock Shine 300 EUDAMED
- Device Name
- Dawn Simulator EUDAMED
- Model / Reference
- BCGE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060006628870 EUDAMED
- Basic UDI-DI
- 506000662000001XP EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I 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
Bodyclock Shine 300 by Outside In (Cambridge) Ltd trading as Lumie — Class I — 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 | 506000662000001XP | Class I | 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 f6358412-88af-4c47-81a8-6570dfd65b7c 61 fields · synced Jul 12, 2026