Identity
- Trade Name
- Lumoral Treatment EUDAMED
- Device Name
- Lumoral Treatment EUDAMED
- Model / Reference
- 01, 11 EUDAMED01 EUDAMED02-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06429810197245 EUDAMEDD-LumoralHY EUDAMED
- Basic UDI-DI
- 6429810197LumoralTreatmP6 EUDAMEDB-LumoralHY 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Red-light phototherapy unit, professional.
- Lumie Brazil — Outside In (Cambridge) Ltd trading as Lumie · Class IIa
- Controller Unit (CU+) — MEDI-TECH INTERNATIONAL CORPORATION · Class II
- PRO WELLNESS — PHOTON 4 HEALTH B.V. · Class I
- Shark cryoglow — SharkNinja Operating LLC · Class IIa
- Bodyclock Luxe 700FM — Outside In (Cambridge) Ltd trading as Lumie · Class I
- BASIC MIND WELLNESS SYSTEM® — PHOTON 4 HEALTH B.V. · Class I
- Ströme Energy+ — Zero-Plus International Limited · Class IIa
- HYDRO 4 HEALTH® LASER ATP WRISTBAND — PHOTON 4 HEALTH B.V. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6429810197LumoralTreatmP6 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6429810197LumoralTreatmP6 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Koite Health Oy
- EUDAMED SRN
- FI-MF-000006901
Sources (2)
- EUDAMED 0d206246-b289-44a3-ab94-02fb860b42e1 61 fields · synced Jun 20, 2026
- EUDAMED 106b20b0-e953-4e8c-bf4c-303d7c617559 61 fields · synced May 18, 2026