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HEAD-830nm/590nm & 415nm
EUDAMEDClass IIa (EU MDR)
Ref HEALITE II Model HEALITE II
Identity
- Trade Name
- HEAD-830nm/590nm & 415nm EUDAMED
- Device Name
- Phototherapy Unit EUDAMED
- Model / Reference
- HEALITE II EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800291820385 EUDAMED
- Basic UDI-DI
- 88002918210704AJ7 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 Cynosure Lutronic Technology 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 | 88002918210704AJ7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cynosure Lutronic Technology Corporation
- EUDAMED SRN
- KR-MF-000047499
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 7d75d8c4-8fe6-491d-a1ab-03a7c375a6b3 61 fields · synced Jun 19, 2026