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Nim NIMCAD300

by Medtronic Xomed Inc

Ref NIMCAD300

Nim NIMCAD300 is a device classified as Class I in the EU and Class II in the US made by Medtronic Xomed Inc, registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI 0763000B00020447G), cleared under FDA 510(k) K213246 on 21 Mar 2022 and listed in FDA GUDID since 17 Jun 2022 (UDI-DI 00763000831509), 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 Number0763000B00020447G Basic UDI-DI 00763000831509UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000831509 UDI-DI Date17 Jun 2022ListedStatusListed 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 0763000B00020447G registered 28 Sep 2026 Active
  • FDA 510(k) K213246 decided 21 Mar 2022 Active
  • FDA GUDID UDI-DI 00763000831509 listed 17 Jun 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213246
  2. Listed FDA GUDID 00763000831509
  3. Registered EUDAMED 0763000B00020447G

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  • Withdrawn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
Electrical-only medical device connection adaptor, reusable
Device name
NIM Accessory Adapter
Model / reference
NIMCAD300
Primary DI / UDI-DI
00763000831509 EUDAMED
00763000112462 GUDID
Basic UDI-DI
0763000B00020447G
510(k) Number
FDA product code
ETN
EMDN code
Z12101199 Peripheral or central neuro stimulation and assessment instruments - other
GMDN term
Electrical-only medical device connection adaptor, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.1820
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00763000831509
GUDID
00763000112462
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00763000831509; FDA GUDID lists 00763000112462), so their flags are not compared. 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: Electrical-only medical device connection adaptor, reusable

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 - OTHER.

Other devices from Medtronic Xomed Inc

See all devices from Medtronic Xomed Inc →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)