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Aura 10 Pet-CT

by XEOS Medical

Ref XHW-100340Model Model A

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

CE IVDR 510(k)

Valid until

Not listed

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) K231420↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number5430002734AURA10PET/CTMV Basic UDI-DI 05430002734026UDI-DIDate17 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number05430002734026 UDI-DI Date9 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK231420 Date10 Aug 2023IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Instrument/analyser specimen/reagent container carrier IVD
Model / Reference
Model A EUDAMED
XHW-100340 EUDAMED
A GUDID
Primary DI / UDI-DI
05430002734026
Basic UDI-DI
5430002734AURA10PET/CTMV
510(k) Number
FDA Product Code
QXL
EMDN Code
W0299 IVD instruments - other
GMDN Term
Instrument/analyser specimen/reagent container carrier IVD
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
892.1200
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Model A
XHW-100340
GUDID
A
Device ClassEUDAMED
Class A
GUDID
Class II

Manufacturer details

EUDAMED SRN
BE-MF-000033451

Properties

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
  • New Device
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No