Identity
- Device Name
- Long-pulsed Alexandrite Laser EUDAMED
- Model / Reference
- CLARITY LPA EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-11101ALR EUDAMED
- Basic UDI-DI
- B-11101ALR EUDAMED
- EMDN Code
- Z12011012 DYE/ALEXANDRITE SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Cyprus EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Long-pulsed Alexandrite Laser by Lutronic Corporation — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-11101ALR | Class IIb | Active |
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Manufacturer
- Manufacturer
- Lutronic Corporation
- EUDAMED SRN
- KR-MF-000009035
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED be8de437-e8ab-46f0-b656-43add9f48182 61 fields · synced Jul 30, 2026