# CareDx Pty Ltd

> Medical device manufacturer record on deviCERTS, compiled from public registries. CareDx Pty Ltd is a medical device manufacturer based in Australia, with 8 devices listed in EUDAMED (EU IVD Annex II List B and IVD General) as of 14 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/caredx-pty-ltd>
- Country: Australia (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED
- EUDAMED SRN: AU-MF-000046711

## Figures

- Devices: 8
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: EUDAMED 8
- Device classes: EU IVD Annex II List B 4, EU IVD General 4
- EMDN [W01 Reagents](https://devicerts.com/categories/emdn/W01): 6 devices
- EMDN [V92 Medical device software - not included in other classes](https://devicerts.com/categories/emdn/V92): 2 devices

## Sites and related companies

- Authorised representative: [QbD RepS BV](https://devicerts.com/representatives/qbd-reps-bv-be-ar-000000040) (Belgium)

## Devices

The first 8 of 8, in the order of the canonical page, which lists them all.

- [AlloSeq Tx 9](https://devicerts.com/devices/alloseq-tx-9-astx9-1-96-a-ivd) · ref ASTX9.1(96)-A-IVD · IVD Annex II List B · EUDAMED · status: Active
- [AlloSeq Tx 9](https://devicerts.com/devices/alloseq-tx-9-astx9-1-96-b-ivd) · ref ASTX9.1(96)-B-IVD · IVD Annex II List B · EUDAMED · status: Active
- [AlloSeq Assign](https://devicerts.com/devices/alloseq-assign-asa1-0) · ref ASA1.0 · IVD General · EUDAMED · status: Active
- [AlloSeq HCT](https://devicerts.com/devices/alloseq-hct-ashct-1-96-ivd) · ref ASHCT.1(96)-IVD · IVD General · EUDAMED · status: Active
- [AlloSeq cfDNA](https://devicerts.com/devices/alloseq-cfdna-ascf-1-24-ivd) · ref ASCF.1(24)-IVD · IVD General · EUDAMED · status: Active
- [AlloSeq cfDNA Software](https://devicerts.com/devices/alloseq-cfdna-software-ascfs1-0) · ref ASCFS1.0 · IVD General · EUDAMED · status: Active
- [AlloSeq Tx 17](https://devicerts.com/devices/alloseq-tx-17-astx17-1-24-ivd) · ref ASTX17.1(24)-IVD · IVD Annex II List B · EUDAMED · status: Active
- [AlloSeq Tx 17](https://devicerts.com/devices/alloseq-tx-17-astx17-1-24-b-ivd) · ref ASTX17.1(24)-B-IVD · IVD Annex II List B · EUDAMED · status: Active

## Source and citation

- Cite as: CareDx Pty Ltd. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/caredx-pty-ltd (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-14
- JSON: <https://devicerts.com/manufacturers/caredx-pty-ltd.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/manufacturers/caredx-pty-ltd
- 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.