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Nim™ NIMDTP35

by Medtronic Xomed Inc

Ref NIMDTP35

Nim NIMDTP35 is a nerve-locating system probe (EU MDR Class IIa; FDA Class II; FDA product code ETN, Stimulator, Nerve) made by Medtronic Xomed Inc, registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI 0763000B00028318F), cleared under FDA 510(k) K231580 on 30 Aug 2023 and listed in FDA GUDID since 11 Aug 2025 (UDI-DI 00763000831479), active as of 8 Nov 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 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231580

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00028318F Basic UDI-DI 00763000831479UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000831479 UDI-DI Date11 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231580 Date30 Aug 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00028318F registered 28 Sep 2026 Active
  • FDA 510(k) K231580 decided 30 Aug 2023 Active
  • FDA GUDID UDI-DI 00763000831479 listed 11 Aug 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231580
  2. Listed FDA GUDID 00763000831479
  3. Registered EUDAMED 0763000B00028318F

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  • Withdrawn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
Nim™
Generic name
Nerve-locating system probe, single-use
Device name
Mono Increment Ball-tip Probes
Model / reference
NIMDTP35
Primary DI / UDI-DI
00763000831479
Basic UDI-DI
0763000B00028318F
510(k) Number
FDA product code
ETN
EMDN code
Z12101185 Peripheral or central neuro stimulation and assessment instruments - consumables
GMDN term
Nerve-locating system probe, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1820
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 35.0 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Nerve-locating system probe, single-use

Cleared under the same submission (K231580)

Similar devices in this category

Other devices filed under PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - CONSUMABLES.

Other devices from Medtronic Xomed Inc

See all devices from Medtronic Xomed Inc →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)