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Xevo 186011468IVD

by Waters Technologies Corporation

Part of a family of 17 devices: see the family page

Ref 186011468IVD

Xevo 186011468IVD is a device classified as Class A in the EU and Class I in the US made by Waters Technologies Corporation, registered in EUDAMED on 4 Oct 2023 (Basic UDI-DI 081677602MSTKPF0802BU) and listed in FDA GUDID since 7 Jul 2026 (UDI-DI 00816776021473), active as of 25 Oct 2026.

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

CE IVDR

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
United StatesGUDID listing GUDID Number00816776021473 UDI-DI Date7 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number081677602MSTKPF0802BU Basic UDI-DI 00816776021473UDI-DIDate4 Oct 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081677602MSTKPF0802BU registered 4 Oct 2023 Active
  • FDA GUDID UDI-DI 00816776021473 listed 7 Jul 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 081677602MSTKPF0802BU
  2. Listed FDA GUDID 00816776021473

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Xevo TQ Absolute XR IVD EUDAMED
Xevo GUDID
Generic name
Mass spectrometry analyser IVD
Device name
Waters IVD Systems
Model / reference
186011468IVD
Primary DI / UDI-DI
00816776021473
Basic UDI-DI
081677602MSTKPF0802BU
FDA product code
DOP
EMDN code
W02079099 Various general purpose IVD instruments - other
GMDN term
Mass spectrometry analyser IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2860
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER.

Other devices from Waters Technologies Corporation

See all devices from Waters Technologies Corporation →

Properties

  • IVD instrument
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)