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Nim™ 8225490X

by Medtronic Xomed Inc

Ref 8225490X

Nim™ 8225490X is a device classified as Class IIa in the EU and Class II in the US made by Medtronic Xomed Inc, registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI 0763000B00028318F), cleared under FDA 510(k) K213246 on 21 Mar 2022 and listed in FDA GUDID since 11 Aug 2025 (UDI-DI 00763000831486), 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) K213246

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 00763000831486UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000831486 UDI-DI Date11 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213246 Date21 Mar 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00028318F registered 28 Sep 2026 Active
  • FDA 510(k) K213246 decided 21 Mar 2022 Active
  • FDA GUDID UDI-DI 00763000831486 listed 11 Aug 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213246
  2. Listed FDA GUDID 00763000831486
  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  • Withdrawn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
8225490X
Primary DI / UDI-DI
00763000831486
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

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 (K213246)

and 1 more cleared under K213246

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)