Protektor 32 Ear Inserts
by Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
Ref 005562
Protektor 32 Ear Inserts (005562) is a device classified as Class I in the EU and Class II in the US made by Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek), registered in EUDAMED on 4 Mar 2026 (Basic UDI-DI 0382830058995VL), cleared under FDA 510(k) K093304 on 11 Aug 2010 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00382830011013), active as of 22 Oct 2026.
Active
Valid until
No date given
FDA recalls
None ongoingTrust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0382830058995VL 00382830011013 | Date4 Mar 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00382830011013 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE GUDID | NumberK093304 | Date11 Aug 2010 | StatusActive |
Official records
- EUDAMED public site 0382830058995VL
- AccessGUDID record 00382830011013
- FDA 510(k) database K093304
Across registries
- EUDAMED Basic UDI-DI 0382830058995VL registered 4 Mar 2026 Active
- FDA 510(k) K093304 decided 11 Aug 2010 Active
- FDA GUDID UDI-DI 00382830011013 listed 20 Sep 2016 Listed
Recalls
-
- Terminated Z-1067-2015
Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.
Timeline
- Cleared FDA 510(k) K093304
- Recall initiated FDA recalls Z-1067-2015
- Listed FDA GUDID 00382830011013
- Registered EUDAMED 0382830058995VL
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Protektor 32 Ear Inserts EUDAMEDNatus GUDID
- Generic name
- Electromyograph
- Model / reference
- 005562
- Primary DI / UDI-DI
- 00382830011013
- Basic UDI-DI
- 0382830058995VL
- Direct marketing DI
- 00382830011013
- 510(k) Number
- FDA product code
- GWF
- EMDN code
- Z12140380 Evoked potential audiometry instruments - hardware accessories
- GMDN term
- Electromyograph
- Device class
- Class I EUDAMEDClass II GUDID
- Regulation number
- 882.1870
- EU registration type
- Standard device
- EU market of registration
- Ireland
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class I | Class II |
| Supplied sterile | No | Yes |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Supplied sterile UDI-DI 00382830011013: EUDAMED states No, FDA GUDID states Yes.
Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.
Manufacturer details
- EUDAMED SRN
- CA-MF-000004001
- Authorised representative
- Natus Manufacturing Ltd IE-AR-000000884
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