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SynAmps2/RT

by Compumedics Limited 3 variants

Ref 9032-0002-01Model SynAmpsRT System Unit Package

SynAmps2/RT (9032-0002-01) is an electroencephalograph (EU MDD Class IIa; FDA Class II; FDA product code GWQ, Full-Montage Standard Electroencephalograph) made by Compumedics Limited, registered in EUDAMED on 26 Mar 2026 (Basic UDI-DI B-09342451001573), cleared under FDA 510(k) K023771 on 6 Feb 2003 and listed in FDA GUDID since 17 Nov 2016 (UDI-DI 09342451001573), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K023771

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-09342451001573 Basic UDI-DI 09342451001573UDI-DIDate26 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09342451001573 UDI-DI Date17 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK023771 Date6 Feb 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-09342451001573 registered 26 Mar 2026 Active
  • FDA 510(k) K023771 decided 6 Feb 2003 Active
  • FDA GUDID UDI-DI 09342451001573 listed 17 Nov 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K023771
  2. Listed FDA GUDID 09342451001573
  3. Registered EUDAMED B-09342451001573

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  • Withdrawn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
Compumedics SynAmps RT
Generic name
Electroencephalograph
Device name
SynAmps2/RT
Model / Ref / Catalog
SynAmpsRT System Unit Package, 9032-0002-01, SynAmps RT
Primary DI / UDI-DI
09342451001573
Basic UDI-DI
B-09342451001573
510(k) Number
FDA product code
GWQ
EMDN code
Z12100302 Electroencephalographs
GMDN term
Electroencephalograph
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1400
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SynAmpsRT System Unit Package
9032-0002-01
GUDID
SynAmps RT
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.

Manufacturer details

EUDAMED SRN
AU-MF-000050437
Authorised representative
Compumedics EUROPE GmbH DE-AR-000039096

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Other devices filed under ELECTROENCEPHALOGRAPHS.

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Properties

  • Measuring function
  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)