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Protektor32 Auditory Stimulation Headphones
EUDAMEDFDA UDIClass I (EU MDR)
Ref 005032
Identity
- Trade Name
- Protektor32 Auditory Stimulation Headphones EUDAMEDNatus FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- Protektor32 Auditory Stimulation Headphones EUDAMEDProtektor 32 Auditory Stim H/phone FDA UDI
- Model / Reference
- 005032 EUDAMEDFDA UDI
- Description
- Protektor 32 Auditory Stim H/phone FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830011259 EUDAMEDFDA UDI
- Basic UDI-DI
- 0382830058988VP EUDAMED
- Direct Marketing DI
- 00382830011259 EUDAMED
- 510(k) Number
- K093304 FDA UDI
- FDA Product Code
- GWF FDA UDI
- EMDN Code
- Z12140380 EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1870 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
Protektor32 Auditory Stimulation Headphones by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0382830058988VP | 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 1290d9f3-4939-4813-adcd-47da9ba9eb72 61 fields · synced Oct 7, 2026
- FDA UDI cf9ef5d2-3289-42a8-b0da-27e64862501b 34 fields · synced May 29, 2026