Identity
- Trade Name
- Natus Photic Stimulator EUDAMED
- Device Name
- LED Photic Stim w/o Stand (50 Hz) - 220V EUDAMED
- Model / Reference
- EXP1102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20382830010034 EUDAMED
- Basic UDI-DI
- 0382830058933UW EUDAMED
- Direct Marketing DI
- 20382830010034 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
Natus Photic Stimulator by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — 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 | 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 fc903cb3-5d94-47e6-abf7-04a883498031 61 fields · synced Oct 7, 2026