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Protektor32 Pods and Pod Kit

by Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek) 39 variants

Part of a family of 47 devices: see the family page

Ref 017848

Protektor32 Pods and Pod Kit (017848) 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 15 Jan 2026 (Basic UDI-DI 038283NA00095EQ), cleared under FDA 510(k) K093304 on 11 Aug 2010 and listed in FDA GUDID since 13 Jul 2018 (UDI-DI 00382830046343), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093304

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038283NA00095EQ Basic UDI-DI 00382830046343UDI-DIDate15 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382830046343 UDI-DI Date13 Jul 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK093304 Date11 Aug 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038283NA00095EQ registered 15 Jan 2026 Active
  • FDA 510(k) K093304 decided 11 Aug 2010 Active
  • FDA GUDID UDI-DI 00382830046343 listed 13 Jul 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-1067-2015 FDA Class II initiated 2 Jan 2015 on shared 510(k) K093304

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K093304
  2. Recall initiated FDA recalls Z-1067-2015
  3. Listed FDA GUDID 00382830046343
  4. Registered EUDAMED 038283NA00095EQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Protektor32 Pods and Pod Kit EUDAMED
Xltek GUDID
Generic name
Electromyograph
Device name
P32 ACQ Pod combine kit
Model / Ref / Catalog
017848
Primary DI / UDI-DI
00382830046343
Basic UDI-DI
038283NA00095EQ
Direct marketing DI
00382830046343
510(k) Number
FDA product code
GWF
EMDN code
Z129013 General auditory and/or visual stimulators
GMDN term
Electromyograph
Device class
Class I EUDAMED
Class 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

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Auditory stimulator

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS.

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)