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CareDx Pty Ltd

Active in EUDAMED

Australiafrom SRN EUDAMED SRN AU-MF-000046711

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.

Devices
8
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • EUDAMED 8
Device classes
  • EU IVD Annex II List B 4
  • EU IVD General 4
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN AU-MF-000046711

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
Authorised rep.
QbD RepS BVBE

What CareDx Pty Ltd makes

CareDx manufactures in vitro diagnostic (IVD) tests for hematopoietic cell transplantation (HCT) and solid organ transplants, including assays for cell-free DNA (cfDNA) analysis, donor-recipient compatibility testing, and genetic profiling. Their portfolio includes software tools designed to interpret and manage test results, such as the AlloSeq Tx series for tissue typing and the AlloSeq cfDNA Software for digital health applications.

The company’s IVD devices are classified under EU Annex II List B and the general IVD category, with listings maintained in the EU’s eudamed registry. CareDx operates from Australia, adhering to regulatory frameworks applicable to diagnostic medical devices in the European Union and its home market.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue8

Newest first, rows 1-8 of 8

  • AlloSeq Tx 9 Ref ASTX9.1(96)-A-IVD

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List B

  • AlloSeq Tx 9 Ref ASTX9.1(96)-B-IVD

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List B

  • AlloSeq Assign Ref ASA1.0

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • AlloSeq HCT Ref ASHCT.1(96)-IVD

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • AlloSeq cfDNA Ref ASCF.1(24)-IVD

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • AlloSeq cfDNA Software Ref ASCFS1.0

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • AlloSeq Tx 17 Ref ASTX17.1(24)-IVD

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List B

  • AlloSeq Tx 17 Ref ASTX17.1(24)-B-IVD

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List B

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
AU-MF-000046711
EUDAMED status
Active
EUDAMED registered name
CareDx Pty Ltd
Registered address
20, Collie Street, 6160 WA, Fremantle, Australia
PRRC contact
Maria Ilar(public in EUDAMED)

From the company website

Read 18 Sep 2026

CareDx delivers transplant-focused diagnostics, digital health tools, and services that support patients and clinicians across the entire transplant journey.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does CareDx Pty Ltd have in the registry?

The registry currently lists 8 devices for CareDx Pty Ltd. Devices recorded under merged duplicate company entries are counted once.

Which registries list CareDx Pty Ltd's devices?

Among its 8 most recently registered devices, CareDx Pty Ltd has devices listed in EUDAMED (8 devices).

What risk classes do CareDx Pty Ltd's devices fall under?

Among its 8 most recently registered devices, the classes recorded for CareDx Pty Ltd's devices are IVD general and IVD Annex II List B. Each device page shows its own class and authorisation.

What are the newest devices from CareDx Pty Ltd in the registry?

The most recently registered devices listed for CareDx Pty Ltd include AlloSeq Tx 9, AlloSeq Assign, AlloSeq HCT and AlloSeq cfDNA.

Generated automatically from registry data and not verified by a human reviewer.