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Nbs 6

by Nexstim Oyj

Ref NX142433

Nbs 6 (NX142433) is a stereotactic neuronavigation/planning system (EU MDR Class IIa; FDA Class II) made by Nexstim Oyj, cleared under FDA 510(k) K252358 on 20 Mar 2026 (3 earlier submissions), registered in EUDAMED on 24 May 2023 (Basic UDI-DI 643006320Nexstim100NBS6H4) and listed in FDA GUDID since 1 Apr 2025 (UDI-DI 06430063200187), 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 MDR 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) K252358

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK252358 Date20 Mar 2026DecidedStatusActive
United StatesGUDID listing GUDID Number06430063200187 UDI-DI Date1 Apr 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number643006320Nexstim100NBS6H4 Basic UDI-DI 06430063200187UDI-DIDate24 May 2023RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K252358 decided 20 Mar 2026 Active· +3 more in the status table
  • EUDAMED Basic UDI-DI 643006320Nexstim100NBS6H4 registered 24 May 2023 Active
  • FDA GUDID UDI-DI 06430063200187 listed 1 Apr 2025 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

7 dated events

  1. Cleared FDA 510(k) K112881
  2. Recall initiated FDA recalls Z-2320-2017
  3. Cleared FDA 510(k) K182700
  4. Registered EUDAMED 643006320Nexstim100NBS6H4
  5. Listed FDA GUDID 06430063200187
  6. Cleared FDA 510(k) K252358
  7. Cleared FDA 510(k) K253098

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  • Withdrawn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
Nbs 6 EUDAMED
Nexstim NBS System GUDID
Generic name
Stereotactic neuronavigation/planning system
Model / reference
NX142433 EUDAMED
6 GUDID
Primary DI / UDI-DI
06430063200187
Basic UDI-DI
643006320Nexstim100NBS6H4
Direct marketing DI
06430063200187
510(k) Number
FDA product code
GWF, HAW, IKN, OBP, QFF, QCI
EMDN code
Z12101106 Neurological stimulators
GMDN term
Stereotactic neuronavigation/planning system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1870, 882.4560, 890.1375, 882.5805, 882.5802
EU registration type
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
NX142433
GUDID
6
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

Similar devices in this category

Other devices filed under NEUROLOGICAL STIMULATORS.

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Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (22, all answered No)