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CLARITY II (ICD Type)
EUDAMEDClass IIb (EU MDR)
Ref CLARITY II (ICD Type)Model CLARITY II, CLARITY II LPA
Identity
- Trade Name
- CLARITY II (ICD Type) EUDAMED
- Device Name
- Long-pulsed Alexandrite + Nd:YAG Laser, Long-pulsed Alexandrite Laser EUDAMED
- Model / Reference
- CLARITY II, CLARITY II LPA EUDAMEDCLARITY II (ICD Type) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809447653723 EUDAMED
- Basic UDI-DI
- 88094476511102AVK 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
CLARITY II (ICD Type) by Lutronic 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 | 88094476511102AVK | 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 df28286e-d5a3-4e7e-9a77-3796aa3936da 61 fields · synced Jul 9, 2026