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Natus Photic Stimulator
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 10440Ref EXP1102
Identity
- Trade Name
- Natus Photic Stimulator EUDAMEDNatus FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- LED Photic Stim w/o Stand (50 Hz) - 220V EUDAMEDNATUS PHOTIC STIM FDA UDI
- Model / Reference
- 10440 EUDAMEDFDA UDIEXP1102 EUDAMED
- Description
- NATUS PHOTIC STIM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830043397 EUDAMEDFDA UDI20382830010034 EUDAMED
- Basic UDI-DI
- 0382830058933UW EUDAMED
- Direct Marketing DI
- 00382830043397 EUDAMED20382830010034 EUDAMED
- 510(k) Number
- K991903 FDA UDI
- FDA Product Code
- GWE FDA UDI
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1890 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Auditory stimulator
Natus Photic Stimulator by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Also classified as Auditory stimulator.
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- Madsen Accuscreen — Natus Medical Denmark ApS · Class IIa
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
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 | K173936 | Class I | Active |
| 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 (4)
- EUDAMED 1cecdafd-b275-4142-8a68-965e721770fe 61 fields · synced Jul 8, 2026
- EUDAMED fc903cb3-5d94-47e6-abf7-04a883498031 61 fields · synced May 18, 2026
- FDA UDI 5558f3a8-89ee-4899-9375-00ca06a1c600 34 fields · synced May 30, 2026
- FDA 510(k) K173936 1 fields · synced May 18, 2026