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Digitimer D185

by Digitimer, Ltd.

Ref D185

Digitimer D185 is a device classified as Class IIa in the EU and Class II in the US made by Digitimer, Ltd., registered in EUDAMED on 8 Oct 2025 (Basic UDI-DI B-05060490360041), cleared under FDA 510(k) K020400 on 23 Aug 2002 and listed in FDA GUDID since 21 Sep 2023 (UDI-DI 05060490360041), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K020400

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05060490360041 Basic UDI-DI 05060490360041UDI-DIDate8 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060490360041 UDI-DI Date21 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK020400 Date23 Aug 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05060490360041 registered 8 Oct 2025 Active
  • FDA 510(k) K020400 decided 23 Aug 2002 Active
  • FDA GUDID UDI-DI 05060490360041 listed 21 Sep 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K020400
  2. Listed FDA GUDID 05060490360041
  3. Registered EUDAMED B-05060490360041

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Digitimer
Generic name
Neurophysiologic monitoring system
Device name
MultiPulse Cortical and Spinal Stimulator
Model / reference
D185
Primary DI / UDI-DI
05060490360041
Basic UDI-DI
B-05060490360041
510(k) Number
FDA product code
GWF
EMDN code
Z12101106 Neurological stimulators
GMDN term
Neurophysiologic monitoring system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1870
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
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: Neurophysiologic monitoring system

Similar devices in this category

Other devices filed under NEUROLOGICAL STIMULATORS.

Other devices from Digitimer, Ltd.

See all devices from Digitimer, Ltd. →

Properties

  • Serial number
  • Manufacturing date
Other properties (21, all answered No)