Identity
- Trade Name
- EcholaserX4 EUDAMED
- Device Name
- Echolaser X4 EUDAMED
- Model / Reference
- M095C1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057017760368 EUDAMED
- Basic UDI-DI
- 805701776M095XX3L EUDAMED
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
EcholaserX4 by El.en. Spa — 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 | 805701776M095XX3L | Class IIb | Active |
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Manufacturer
- Manufacturer
- El.en. Spa
- EUDAMED SRN
- IT-MF-000007370
Sources (1)
- EUDAMED 1cd021fa-8438-4c37-b30b-5bebbcd4d1ab 61 fields · synced Jul 17, 2026