Identity
- Trade Name
- VLED EUDAMED
- Device Name
- LED for Visual Evoked Potentials (VEP) EUDAMED
- Model / Reference
- VLED03 EUDAMEDVLED02 EUDAMEDVLED04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18054655029540 EUDAMED18054655028925 EUDAMED18054655029557 EUDAMED
- Basic UDI-DI
- 8054655000018Y9 EUDAMED
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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: Auditory stimulator
Vled by Spes Medica S.p.A. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8054655000018Y9 | Class I | Active |
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Manufacturer
- Manufacturer
- Spes Medica S.p.A.
- EUDAMED SRN
- IT-MF-000008858
Sources (3)
- EUDAMED 0c46aa23-f48b-450d-aa04-ee86ed972ee6 61 fields · synced Jul 24, 2026
- EUDAMED d605ebfd-0419-4721-9fcd-625de8b23a54 61 fields · synced May 18, 2026
- EUDAMED 7f44e4fe-125e-4ab5-abf6-79ecf1304879 61 fields · synced May 18, 2026