Identity
- Trade Name
- NATUS PHOTIC STIM KIT EUDAMEDNatus FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- LED Photic Stim w/o Stand (50 Hz) - 220V EUDAMEDNatus Photic Stim Kit FDA UDI
- Model / Reference
- 003555 EUDAMEDFDA UDI
- Description
- Natus Photic Stim Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830015790 EUDAMEDFDA UDI
- Basic UDI-DI
- 0382830058933UW EUDAMED
- Direct Marketing DI
- 00382830015790 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 Stim Kit by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Auditory stimulator.
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- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0382830058933UW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (2)
- EUDAMED ac72da90-27d2-476d-ba93-e8762afa9df8 61 fields · synced Jun 18, 2026
- FDA UDI 252f7518-fbff-4b34-afac-d4bef6731053 34 fields · synced May 30, 2026