Identity
- Trade Name
- Bodyclock Luxe 750DAB EUDAMED
- Device Name
- Dawn Simulator EUDAMED
- Model / Reference
- BCLI-D75L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060006629235 EUDAMED
- Basic UDI-DI
- 506000662000001XP EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT 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
Bodyclock Luxe 750DAB by Outside In (Cambridge) Ltd trading as Lumie — 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 | 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 f8227e66-16c7-486e-a307-08d7989649ce 61 fields · synced Oct 5, 2026