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LED Photic Stim Plus Roll Stand (50 Hz) - 220V
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref EXP1103510(k) K896836
Identity
- Trade Name
- LED Photic Stim Plus Roll Stand (50 Hz) - 220V EUDAMED
- Device Name
- LED Photic Stim w/o Stand (50 Hz) - 220V EUDAMED
- Model / Reference
- EXP1103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830010061 EUDAMED
- Basic UDI-DI
- 0382830058933UW EUDAMED
- Direct Marketing DI
- 00382830010061 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
LED Photic Stim Plus Roll Stand (50 Hz) - 220V by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — FDA_510K, MDR — listed in EUDAMED, FDA…
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K896836 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0382830058933UW | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- FDA Applicant
- Excel Tech. , Ltd.
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (2)
- EUDAMED 3a271a99-b2d0-4c26-b0d0-25bc12ceea23 85 fields · synced Jun 18, 2026
- FDA 510(k) K896836 1 fields · synced May 18, 2026