Identity
- Trade Name
- Bodyclock Spark 100 EUDAMED
- Device Name
- Dawn Simulator EUDAMED
- Model / Reference
- BCKE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060006628795 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
Bodyclock Spark 100 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 a72ff249-c64d-4334-930b-66dbc43a9324 61 fields · synced Jun 18, 2026