Identity
- Trade Name
- Nicolet LED Photic Stim Kit EUDAMED
- Device Name
- LED Photic Stim w/o Stand (50 Hz) - 220V EUDAMED
- Model / Reference
- 019881 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830058483 EUDAMED
- Basic UDI-DI
- 0382830058933UW EUDAMED
- Direct Marketing DI
- 00382830058483 EUDAMED
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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: Auditory stimulator
Nicolet LED Photic Stim Kit by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — 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 | 0382830058933UW | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (1)
- EUDAMED 9c86f323-fabc-481c-b0cb-0f859b487662 61 fields · synced Jun 19, 2026