Identity
- Trade Name
- 12 mm, 14 mm, 16 mm cartridge (Optional) EUDAMED12 mm, 14 mm, 16 mm cartridge EUDAMED
- Device Name
- Long-pulsed Nd:YAG Laser EUDAMEDLong pulsed Nd:YAG Laser EUDAMED
- Model / Reference
- DermaV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800291820293 EUDAMED08809447656373 EUDAMED
- Basic UDI-DI
- 88002918210116AH8 EUDAMED88094476510116AVR EUDAMED
- EMDN Code
- Z12011019 MULTI–PLATFORM LASER EUDAMED
Classification
- Device Class
- Class IIb 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
12 mm, 14 mm, 16 mm cartridge (Optional) by Cynosure Lutronic Technology Corporation — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 88002918210116AH8 | Class IIb | 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 d50da048-1bd8-43ae-a95d-54c0cd57bf0f 61 fields · synced Oct 5, 2026
- EUDAMED 16c010e7-b14b-4921-9c7b-e721d65c4242 61 fields · synced May 18, 2026