# CAAS Qardia

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

- Canonical page: <https://devicerts.com/devices/caas-qardia-1-0>
- Manufacturer: [Pie Medical Imaging B.V.](https://devicerts.com/manufacturers/fda-fei-3003595527) (Netherlands)
- Device class: Class IIa (EU MDD)
- EMDN: Z11039082 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-08056304454355 · UDI-DI 08056304454355 · registered 2022-09-27 · status: Active
- **510(k)** · FDA 510(k) · United States · K212376 · issued 2022-05-16 · status: Active

## Recalls

No recall on record.

## Identity

- Device name: CAAS Qardia 1.0 [EUDAMED]
- Model / reference: CAAS Qardia [EUDAMED]; 1.0 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 08056304454355 [EUDAMED]
- Basic UDI-DI: B-08056304454355 [EUDAMED]
- EMDN code: Z11039082 [EUDAMED]

## Classification

- Device class: Class IIa [EUDAMED]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Netherlands [EUDAMED]

## Properties

- Measuring function: Yes [EUDAMED]
- Supplied sterile: No [EUDAMED]
- Sterilise before use: No [EUDAMED]
- Implantable: No [EUDAMED]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED]
- Reprocessed single-use device: 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]
- Administering medicine: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]

## Source and citation

- Cite as: CAAS Qardia, Pie Medical Imaging B.V. deviCERTS medical device catalogue. https://devicerts.com/devices/caas-qardia-1-0 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/caas-qardia-1-0.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/caas-qardia-1-0
- 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.