Identity
- Trade Name
- XEN EUDAMED
- Device Name
- Photobiomodulation System EUDAMED
- Model / Reference
- XEN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09362129000004 EUDAMED
- Basic UDI-DI
- 93621290XENLEDRH EUDAMED
- Direct Marketing DI
- 09362129000004 EUDAMED
- EMDN Code
- X0599 HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Xen by Australian Aesthetic Devices — Class IIa — 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 | 93621290XENLEDRH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Australian Aesthetic Devices
- EUDAMED SRN
- AU-MF-000041530
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 57cb6cce-4c6f-4da8-a1c7-43bd34b4006f 61 fields · synced Jun 19, 2026