# Vave VA-0327

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/vave-va-0327>
- Manufacturer: [Vave Health Inc](https://devicerts.com/manufacturers/fda-fei-3016854601) (United States)
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: ITX, IYO, IYN
- EMDN: Z11040106 HANDHELD ULTRASOUND SCANNERS
- GMDN: Hand-held ultrasound imaging system, body-surface (60924)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 0850001977VAF01R4 · UDI-DI 00850001977081 · registered 2026-07-31 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00850001977081 · listed 2024-09-23 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: Vave Universal Ultrasound [EUDAMED]; Vave [FDA GUDID (AccessGUDID)]
- Generic name: Hand-held ultrasound imaging system, body-surface [FDA GUDID (AccessGUDID)]
- Device name: Vave Wireless Ultrasound System [EUDAMED]
- Model / reference: VA-0327 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00850001977081 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 0850001977VAF01R4 [EUDAMED]
- Direct marketing DI: 00850001977081 [EUDAMED]
- FDA product code: ITX [FDA GUDID (AccessGUDID)]; IYO [FDA GUDID (AccessGUDID)]; IYN [FDA GUDID (AccessGUDID)]
- EMDN code: Z11040106 [EUDAMED]
- GMDN term: Hand-held ultrasound imaging system, body-surface (60924) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.1570 [FDA GUDID (AccessGUDID)]; 892.1560 [FDA GUDID (AccessGUDID)]; 892.1550 [FDA GUDID (AccessGUDID)]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Italy [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Measuring function: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Vave VA-0327, Vave Health Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/vave-va-0327 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/vave-va-0327.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/vave-va-0327
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.