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Fractional (FRX) cartridge
EUDAMEDClass IIb (EU MDR)
Ref CLARITY II, CLARITY II LPA
Identity
- Trade Name
- Fractional (FRX) cartridge EUDAMED
- Device Name
- Long-pulsed Alexandrite + Nd:YAG Laser, Long-pulsed Alexandrite Laser EUDAMED
- Model / Reference
- CLARITY II, CLARITY II LPA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800291820118 EUDAMED
- Basic UDI-DI
- 88002918211102AH2 EUDAMED
- EMDN Code
- Z12011012,Z12011019 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
Fractional (FRX) cartridge 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 | 88002918211102AH2 | 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 2ddd227d-3b57-40ac-be0b-f061a0c81715 61 fields · synced Jun 18, 2026
- EUDAMED 2ddd227d-3b57-40ac-be0b-f061a0c81715-1 61 fields · synced Jun 10, 2026