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Aquarius CT AQS2000

by Laborie Medical Technologies Canada ULC

Ref AQS2000

Aquarius CT AQS2000 is a device classified as Class IIa in the EU and Class II in the US made by Laborie Medical Technologies Canada ULC, registered in EUDAMED on 29 Jun 2026 (Basic UDI-DI B-00627825003537) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00627825003537), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00627825003537 Basic UDI-DI 00627825003537UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00627825003537 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00627825003537 registered 29 Jun 2026 Active
  • FDA GUDID UDI-DI 00627825003537 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00627825003537
  2. Registered EUDAMED B-00627825003537

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Aquarius Urodynamics Analyzer System EUDAMED
Aquarius CT GUDID
Generic name
Urodynamic measurement system
Model / reference
AQS2000
Primary DI / UDI-DI
00627825003537
Basic UDI-DI
B-00627825003537
FDA product code
FEN
EMDN code
Z12160401 Urodynamics systems
GMDN term
Urodynamic measurement system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1620
EU registration type
Legacy device (under a directive)
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: Urodynamic measurement system

Similar devices in this category

Other devices filed under URODYNAMICS SYSTEMS.

Other devices from Laborie Medical Technologies Canada ULC

See all devices from Laborie Medical Technologies Canada ULC →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)