Skip to content

NexSpeech

by Nexstim Oyj

Ref NX92527

NexSpeech (NX92527) is a stereotactic neuronavigation/planning system (EU MDD Class IIa; FDA Class II) made by Nexstim Oyj, registered in EUDAMED on 16 Dec 2021 (Basic UDI-DI B-06430063200026), cleared under FDA 510(k) K112881 on 22 May 2012 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 06430063200026), active as of 22 Oct 2026. One FDA recall is linked to it.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K112881

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/MDD EUDAMED NumberB-06430063200026 Basic UDI-DI 06430063200026UDI-DIDate16 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number06430063200026 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK112881 Date22 May 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06430063200026 registered 16 Dec 2021 Active
  • FDA 510(k) K112881 decided 22 May 2012 Active
  • FDA GUDID UDI-DI 06430063200026 listed 21 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2320-2017 FDA Class II initiated 14 Mar 2017

    Software defect: the NBS software may accidentally generate duplicate copies of one or several files.

Timeline

4 dated events

  1. Cleared FDA 510(k) K112881
  2. Listed FDA GUDID 06430063200026
  3. Recall initiated FDA recalls Z-2320-2017
  4. Registered EUDAMED B-06430063200026

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
NexSpeech EUDAMED
NexSpeech main software GUDID
Generic name
Stereotactic neuronavigation/planning system
Model / reference
NX92527 EUDAMED
2 GUDID
Primary DI / UDI-DI
06430063200026
Basic UDI-DI
B-06430063200026
510(k) Number
FDA product code
IKN, GWF, HAW
EMDN code
Z12101106 Neurological stimulators
GMDN term
Stereotactic neuronavigation/planning system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
890.1375, 882.1870, 882.4560
EU registration type
Legacy device (under a directive)
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
NX92527
GUDID
2
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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
FI-MF-000006696

Related devices

Category: Point aesthesiometer

Similar devices in this category

Other devices filed under NEUROLOGICAL STIMULATORS.

Other devices from Nexstim Oyj

See all devices from Nexstim Oyj →

Properties

  • Measuring function
  • Prescription use
Other properties (21, all answered No)