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HEAD-830nm/590nm & 633nm BOX
EUDAMEDClass IIa (EU MDR)
Ref HEALITE II Model HEALITE II
Identity
- Trade Name
- HEAD-830nm/590nm & 633nm BOX EUDAMEDHEAD-830nm/590nm EUDAMED
- Device Name
- Phototherapy Unit EUDAMED
- Model / Reference
- HEALITE II EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800291820378 EUDAMED08800291820347 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 & 633nm BOX 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 (2)
- EUDAMED b518bb27-fd4f-406b-a526-f7313f99be21 61 fields · synced Oct 6, 2026
- EUDAMED 34d02a25-19d0-41c4-a18c-0d75f10300b4 61 fields · synced May 16, 2026