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micromed BRAIN QUICK

by Micromed, Inc.

Ref BRAIN QUICK

micromed BRAIN QUICK is a device classified as Class IIb in the EU and Class II in the US made by Micromed, Inc., registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI B-08033928120910), cleared under FDA 510(k) K171384 on 1 Feb 2018 and listed in FDA GUDID since 21 Mar 2018 (UDI-DI 08033928120910), active as of 25 Oct 2026. One FDA recall is linked to it.

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171384

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-08033928120910 Basic UDI-DI 08033928120910UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033928120910 UDI-DI Date21 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171384 Date1 Feb 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033928120910 registered 24 Jun 2026 Active
  • FDA 510(k) K171384 decided 1 Feb 2018 Active
  • FDA GUDID UDI-DI 08033928120910 listed 21 Mar 2018 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2353-2026 FDA Class II initiated 4 May 2026

    Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results.

Timeline

4 dated events

  1. Cleared FDA 510(k) K171384
  2. Listed FDA GUDID 08033928120910
  3. Recall initiated FDA recalls Z-2353-2026
  4. Registered EUDAMED B-08033928120910

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
micromed
Generic name
Electroencephalograph
Model / reference
BRAIN QUICK
Primary DI / UDI-DI
08033928120910
Basic UDI-DI
B-08033928120910
510(k) Number
FDA product code
OLV, GWQ
EMDN code
Z12100302 Electroencephalographs
GMDN term
Electroencephalograph
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.1400
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Electroencephalograph

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHS.

Other devices from Micromed, Inc.

See all devices from Micromed, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)