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Vave VA-0327

by Vave Health Inc

Ref VA-0327

Vave VA-0327 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 31 Jul 2026 (Basic UDI-DI 0850001977VAF01R4) and listed in FDA GUDID since 23 Sep 2024 (UDI-DI 00850001977081), active as of 24 Oct 2026.

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

CE MDR

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850001977VAF01R4 Basic UDI-DI 00850001977081UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850001977081 UDI-DI Date23 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850001977VAF01R4 registered 31 Jul 2026 Active
  • FDA GUDID UDI-DI 00850001977081 listed 23 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850001977081
  2. Registered EUDAMED 0850001977VAF01R4

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Vave Universal Ultrasound EUDAMED
Vave GUDID
Generic name
Hand-held ultrasound imaging system, body-surface
Device name
Vave Wireless Ultrasound System
Model / reference
VA-0327
Primary DI / UDI-DI
00850001977081
Basic UDI-DI
0850001977VAF01R4
Direct marketing DI
00850001977081
FDA product code
ITX, IYO, IYN
EMDN code
Z11040106 Handheld ultrasound scanners
GMDN term
Hand-held ultrasound imaging system, body-surface
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570, 892.1560, 892.1550
System or procedure pack
System which is a device in itself
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 HANDHELD ULTRASOUND SCANNERS.

Other devices from Vave Health Inc

  • Vave VA-0182, VUSP3

    Class II

  • Vave VA-0175

    Class II

  • Vave VA-0330

    Class II

  • Vave VBT

    Class II

See all devices from Vave Health Inc →

Properties

  • Measuring function
  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)