Identity
- Trade Name
- Lumoral Treatment EUDAMED
- Device Name
- Lumoral Treatment EUDAMED
- Model / Reference
- 01, 11 EUDAMED01, 03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06429810197153 EUDAMED
- Basic UDI-DI
- 6429810197LumoralTreatmP6 EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
Lumoral Treatment by Koite Health Oy — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 6429810197LumoralTreatmP6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Koite Health Oy
- EUDAMED SRN
- FI-MF-000006901
Sources (2)
- EUDAMED 2de10c1d-a29e-435f-b8fd-e99f1c09dafa 61 fields · synced Jul 15, 2026
- EUDAMED 2de10c1d-a29e-435f-b8fd-e99f1c09dafa-1 61 fields · synced Jun 9, 2026