Identity
- Trade Name
- SmoothSkin Pure Mini Lite EUDAMED
- Device Name
- Intense pulsed light equipment for hair removal, Annex XVI EUDAMED
- Model / Reference
- SSB2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976933651203 EUDAMED
- Basic UDI-DI
- 506035278IPL0144 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Croatia 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: Device sterilization/disinfection container, reusable
SmoothSkin Pure Mini Lite by Cyden Limited — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213692 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 506035278IPL0144 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cyden Limited
- EUDAMED SRN
- UK-MF-000039581
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED bb92dd5b-39f0-4de7-9a85-c35b866dbff6 61 fields · synced Jul 8, 2026
- FDA 510(k) K213692 1 fields · synced May 18, 2026