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STIMPOD NMT Monitoring Cable AMG (3.0m)

by Xavant Technology (Pty) Ltd

Ref XT-45025B

STIMPOD NMT Monitoring Cable AMG (3.0m) (XT-45025B) is a device classified as Class I in the EU and Class II in the US made by Xavant Technology (Pty) Ltd, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 06009880396XT45025BQ), cleared under FDA 510(k) K213049 on 16 Oct 2022 and listed in FDA GUDID since 15 Nov 2024 (UDI-DI 06009880396429), 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 found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213049

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 Number06009880396XT45025BQ Basic UDI-DI 06009880396429UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06009880396429 UDI-DI Date15 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213049 Date16 Oct 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 06009880396XT45025BQ registered 21 May 2026 Active
  • FDA 510(k) K213049 decided 16 Oct 2022 Active
  • FDA GUDID UDI-DI 06009880396429 listed 15 Nov 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213049
  2. Listed FDA GUDID 06009880396429
  3. Registered EUDAMED 06009880396XT45025BQ

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  • Withdrawn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
NMT Monitoring Cable AMG (3.0m) EUDAMED
Stimpod GUDID
Generic name
Diagnostic peripheral nerve electrical stimulation system
Device name
NMT Monitoring Cable AMG
Model / Ref / Catalog
XT-45025B, NMT Monitoring Cable AMG (3.0m)
Primary DI / UDI-DI
06009880396429
Basic UDI-DI
06009880396XT45025BQ
510(k) Number
FDA product code
BXN
EMDN code
Z12062880 Neuromuscular stimulation equipment - hardware accessories
GMDN term
Diagnostic peripheral nerve electrical stimulation system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.2775
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
XT-45025B
GUDID
NMT Monitoring Cable AMG (3.0m)
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.

Related devices

Category: Diagnostic peripheral nerve electrical stimulation system

Similar devices in this category

Other devices filed under NEUROMUSCULAR STIMULATION EQUIPMENT.

Other devices from Xavant Technology (Pty) Ltd

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Properties

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