Identity
- Trade Name
- HEAD-830nm/590nm & 415nm EUDAMEDHEAD-830nm/590nm & 415nm BOX EUDAMED
- Device Name
- Phototherapy Unit EUDAMED
- Model / Reference
- HEALITE II EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809447656717 EUDAMED18809447656714 EUDAMED
- Basic UDI-DI
- 88094476510704AWQ EUDAMED
- EMDN Code
- Z12040299 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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: Dermatological laser beam guiding handpiece
HEAD-830nm/590nm & 415nm by Lutronic Corporation — 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 | 88094476510704AWQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lutronic Corporation
- EUDAMED SRN
- KR-MF-000009035
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4f008e5a-822e-4465-b462-f82ec0764beb 61 fields · synced Jul 24, 2026
- EUDAMED f08588d7-d72e-4aef-a6e2-a238c1bad277 61 fields · synced May 18, 2026