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Vave VA-0330

by Vave Health Inc

Ref VA-0330

Vave VA-0330 is a device classified as Class IIa in the EU and Class II in the US made by Vave Health Inc, registered in EUDAMED on 26 Aug 2026 (Basic UDI-DI 0850001977VAF02R6), cleared under FDA 510(k) K241051 on 30 Aug 2024 and listed in FDA GUDID since 4 Nov 2024 (UDI-DI 00850001977104), active as of 24 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241051

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850001977VAF02R6 Basic UDI-DI 00850001977104UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850001977104 UDI-DI Date4 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241051 Date30 Aug 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0850001977VAF02R6 registered 26 Aug 2026 Active
  • FDA 510(k) K241051 decided 30 Aug 2024 Active
  • FDA GUDID UDI-DI 00850001977104 listed 4 Nov 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241051
  2. Listed FDA GUDID 00850001977104
  3. Registered EUDAMED 0850001977VAF02R6

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Vave Health Software Application EUDAMED
Vave GUDID
Generic name
Hand-held ultrasound imaging system, body-surface
Device name
Vave Software Application
Model / reference
VA-0330
Primary DI / UDI-DI
00850001977104
Basic UDI-DI
0850001977VAF02R6
Direct marketing DI
00850001977104
510(k) Number
FDA product code
IYN, ITX, IYO
EMDN code
Z11040182 Ultrasound scanners - software accessories
GMDN term
Hand-held ultrasound imaging system, body-surface
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1550, 892.1570, 892.1560
Special device type
Software
EU registration type
Standard device
EU market of registration
Italy
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: Hand-held ultrasound imaging system, body-surface

Similar devices in this category

Other devices filed under ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES.

Other devices from Vave Health Inc

  • Vave VA-0182, VUSP3

    Class II

  • Vave VA-0175

    Class II

  • Vave VA-0327

    Class II

  • Vave VBT

    Class II

See all devices from Vave Health Inc →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)