# CareDx AB

> Medical device manufacturer record on deviCERTS, compiled from public registries. CareDx AB is a medical device manufacturer based in Sweden, with 185 devices listed in EUDAMED and FDA GUDID (EU IVD Annex II List B, IVD General, Class C and Class A) as of 14 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/caredx-ab>
- Country: Sweden (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: SE-MF-000040995
- FDA FEI: 3002522915
- DUNS: 558836388

## Figures

- Devices: 185
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0
- FDA establishments: 1

## Registry facts

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

- Registries: EUDAMED 185, FDA GUDID 165
- Device classes: EU IVD Annex II List B 128, EU IVD General 44, EU Class C 12, EU Class A 1
- EMDN [W01 Reagents](https://devicerts.com/categories/emdn/W01): 184 devices
- EMDN [V92 Medical device software - not included in other classes](https://devicerts.com/categories/emdn/V92): 1 devices

## Devices

The first 50 of 185, in the order of the canonical page, which lists them all.

- [AlloSeq Tx](https://devicerts.com/devices/alloseq-tx-404-111-96) · ref 404.111-96 · Class C · EUDAMED · status: Active
- [Olerup QTYPE LC480 II Cal Plate](https://devicerts.com/devices/olerup-qtype-lc480-ii-cal-plate-203-501-01) · ref 203.501-01 · IVD General · EUDAMED · status: Active
- [AlloSeq cfDNA](https://devicerts.com/devices/alloseq-cfdna-505-101-24) · ref 505.101-24 · Class C · EUDAMED · status: Active
- [AlloSeq HCT](https://devicerts.com/devices/alloseq-hct-606-101-96) · ref 606.101-96 · Class C · EUDAMED · status: Active
- [HLA Wipe Test](https://devicerts.com/devices/hla-wipe-test-102-101-01u) · ref 102.101-01u · IVD General · EUDAMED · status: Active
- [QTYPE Colour Compensation Plate](https://devicerts.com/devices/qtype-colour-compensation-plate-203-501-01) · ref 203.501-01 · Class A · EUDAMED · status: Active
- [AlloSeq Tx](https://devicerts.com/devices/alloseq-tx-404-112-96) · ref 404.112-96 · Class C · EUDAMED · status: Active
- [Ssp Hla-B\*50](https://devicerts.com/devices/ssp-hla-b-50-101-548-06u) · ref 101-548-06u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp DRB1\*09](https://devicerts.com/devices/ssp-drb1-09-101-120-06u) · ref 101.120-06u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-A\*03](https://devicerts.com/devices/ssp-hla-a-03-101-413-04u) · ref 101.413-04u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp DRB5\*01:08N](https://devicerts.com/devices/ssp-drb5-01-08n-101-812-12u) · ref 101.812-12u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-B\*82](https://devicerts.com/devices/ssp-hla-b-82-101-552-06u) · ref 101.552-06u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp DRB4](https://devicerts.com/devices/ssp-drb4-101-122-06u) · ref 101.122-06u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp DPB1](https://devicerts.com/devices/ssp-dpb1-101-311-24u) · ref 101.311-24u · IVD General · EUDAMED, GUDID · status: Active
- [Ssp Hla-C\*17](https://devicerts.com/devices/ssp-hla-c-17-101-628-06u) · ref 101.628-06u · IVD General · EUDAMED, GUDID · status: Active
- [Ssp Hla-B\*44](https://devicerts.com/devices/ssp-hla-b-44-101-563-24u) · ref 101.563-24u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-B\*57](https://devicerts.com/devices/ssp-hla-b-57-101-567-12u) · ref 101.567-12u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-B\*5701](https://devicerts.com/devices/ssp-hla-b-5701-101-572-12u) · ref 101.572-12u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-A\*02](https://devicerts.com/devices/ssp-hla-a-02-101-412-24u) · ref 101.412-24u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-A\*68](https://devicerts.com/devices/ssp-hla-a-68-101-418-04u) · ref 101.418-04u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-B\*49](https://devicerts.com/devices/ssp-hla-b-49-101-547-06u) · ref 101.547-06u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [AlloSeq Tx](https://devicerts.com/devices/alloseq-tx-404-172-96) · ref 404.172-96 · Class C · EUDAMED · status: Active
- [Ssp Hla-B\*18](https://devicerts.com/devices/ssp-hla-b-18-101-519-12u) · ref 101.519-12u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [SSP HLA-B\*27 high](https://devicerts.com/devices/ssp-hla-b-27-high-101-521-24u) · ref 101.521-24u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-B\*13](https://devicerts.com/devices/ssp-hla-b-13-101-515-12u) · ref 101.515-12u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp DQB1\*05](https://devicerts.com/devices/ssp-dqb1-05-101-211-24u) · ref 101.211-24u · IVD General · EUDAMED, GUDID · status: Active
- [Ssp DQB1\*06](https://devicerts.com/devices/ssp-dqb1-06-101-212-24u) · ref 101.212-24u · IVD General · EUDAMED, GUDID · status: Active
- [Ssp Hla-B\*07](https://devicerts.com/devices/ssp-hla-b-07-101-512-03u) · ref 101.512-03u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-C\*14](https://devicerts.com/devices/ssp-hla-c-14-101-625-06u) · ref 101.625-06u · IVD General · EUDAMED, GUDID · status: Active
- [Olerup QTYPE 11](https://devicerts.com/devices/olerup-qtype-11-201-701-03) · ref 201.701-03 · IVD Annex II List B · EUDAMED · status: Active
- [Ssp DRB1\*14](https://devicerts.com/devices/ssp-drb1-14-101-117-12u) · ref 101.117-12u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp DQB1\*03](https://devicerts.com/devices/ssp-dqb1-03-101-124-06u) · ref 101.124-06u · IVD General · EUDAMED, GUDID · status: Active
- [Ssp Hla-A\*24](https://devicerts.com/devices/ssp-hla-a-24-101-422-24u) · ref 101.422-24U · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp DRB1\*07](https://devicerts.com/devices/ssp-drb1-07-101-118-24u) · ref 101.118-24u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-B\*37](https://devicerts.com/devices/ssp-hla-b-37-101-541-06u) · ref 101.541-06u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-B\*14](https://devicerts.com/devices/ssp-hla-b-14-101-524-12u) · ref 101.524-12u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [SSP DQB1 high](https://devicerts.com/devices/ssp-dqb1-high-101-221-12u) · ref 101.221-12u · IVD General · EUDAMED, GUDID · status: Active
- [SSP HLA C high](https://devicerts.com/devices/ssp-hla-c-high-101-707-12u) · ref 101.707-12u · IVD General · EUDAMED, GUDID · status: Active
- [Ssp Hla-C\*04](https://devicerts.com/devices/ssp-hla-c-04-101-612-12u) · ref 101.612-12u · IVD General · EUDAMED, GUDID · status: Active
- [Ssp DPA1](https://devicerts.com/devices/ssp-dpa1-101-331-24u) · ref 101.331-24u · IVD General · EUDAMED, GUDID · status: Active
- [Ssp DRB5](https://devicerts.com/devices/ssp-drb5-101-123-24u) · ref 101.123-24u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-B\*44](https://devicerts.com/devices/ssp-hla-b-44-101-563-03u) · ref 101.563-03u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-A\*68](https://devicerts.com/devices/ssp-hla-a-68-101-418-12u) · ref 101.418-12u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-A\*69](https://devicerts.com/devices/ssp-hla-a-69-101-435-06u) · ref 101.435-06u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [SSP KIR Genotyping](https://devicerts.com/devices/ssp-kir-genotyping-104-101-12u) · ref 104.101-12u · IVD General · EUDAMED · status: Active
- [Ssp Hla-B\*40](https://devicerts.com/devices/ssp-hla-b-40-101-523-03u) · ref 101.523-03u · IVD Annex II List B · EUDAMED, GUDID · status: Active
- [Ssp Hla-C\*07](https://devicerts.com/devices/ssp-hla-c-07-101-615-24u) · ref 101.615-24u · IVD General · EUDAMED, GUDID · status: Active
- [Ssp DQB1\*03](https://devicerts.com/devices/ssp-dqb1-03-101-214-24u) · ref 101.214-24u · IVD General · EUDAMED, GUDID · status: Active
- [Ssp Hla-C\*15](https://devicerts.com/devices/ssp-hla-c-15-101-626-12u) · ref 101.626-12u · IVD General · EUDAMED, GUDID · status: Active
- [Ssp Hla-B\*39](https://devicerts.com/devices/ssp-hla-b-39-101-566-04u) · ref 101.566-04u · IVD Annex II List B · EUDAMED, GUDID · status: Active

## EU certificates

- HX 7091956-1 · Quality management system · IVDR · notified body TÜV Rheinland LGA Products GmbH · issued 2026-09-18 · expires 2030-09-23 · status: supplemented

## Source and citation

- Cite as: CareDx AB. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/caredx-ab (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- 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-ab.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-ab
- 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.