Identity
- Trade Name
- Lumoral protective plastic cover EUDAMED
- Device Name
- Plastic cover EUDAMED
- Model / Reference
- 60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06429810197283 EUDAMED
- Basic UDI-DI
- 6429810197Plasticcover7J EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I 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 protective plastic cover by Koite Health Oy — Class I — 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 | 6429810197Plasticcover7J | Class I | Active |
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Manufacturer
- Manufacturer
- Koite Health Oy
- EUDAMED SRN
- FI-MF-000006901
Sources (1)
- EUDAMED 9a80aac8-c648-4bc2-a04a-ac7697d67656 61 fields · synced Jul 17, 2026