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CareDx AB

Active in EUDAMED

Swedenfrom SRN EUDAMED FDA SRN SE-MF-000040995 FEI 3002522915

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.

Devices
185
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • EUDAMED 185
  • FDA GUDID 165

A device listed in two registries counts in both.

Device classes
  • EU IVD Annex II List B 128
  • EU IVD General 44
  • EU Class C 12
  • EU Class A 1
Top EMDN categories
Identifiers
  • EUDAMED SRN SE-MF-000040995
  • FDA FEI 3002522915
  • DUNS 558836388

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA establishment

Catalogue185

Newest first, rows 1-50 of 185

Search and filter all 185 devices
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  • AlloSeq Tx Ref 404.111-96

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Olerup QTYPE LC480 II Cal Plate Ref 203.501-01

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

  • AlloSeq cfDNA Ref 505.101-24

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • AlloSeq HCT Ref 606.101-96

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • HLA Wipe Test Ref 102.101-01u

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

  • QTYPE Colour Compensation Plate Ref 203.501-01

    Active Regimes: CE IVDR Registry: EUDAMED Class:A

  • AlloSeq Tx Ref 404.112-96

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Ssp Hla-B*50 Ref 101-548-06u

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

  • Ssp DRB1*09 Ref 101.120-06u

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

  • Ssp Hla-A*03 Ref 101.413-04u

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

  • Ssp DRB5*01:08N Ref 101.812-12u

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

  • Ssp Hla-B*82 Ref 101.552-06u

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

  • Ssp DRB4 Ref 101.122-06u

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

  • Ssp DPB1 Ref 101.311-24u

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

  • Ssp Hla-C*17 Ref 101.628-06u

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

  • Ssp Hla-B*44 Ref 101.563-24u

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

  • Ssp Hla-B*57 Ref 101.567-12u

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

  • Ssp Hla-B*5701 Ref 101.572-12u

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

  • Ssp Hla-A*02 Ref 101.412-24u

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

  • Ssp Hla-A*68 Ref 101.418-04u

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

  • Ssp Hla-B*49 Ref 101.547-06u

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

  • AlloSeq Tx Ref 404.172-96

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Ssp Hla-B*18 Ref 101.519-12u

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

  • SSP HLA-B*27 high Ref 101.521-24u

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

  • Ssp Hla-B*13 Ref 101.515-12u

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

  • Ssp DQB1*05 Ref 101.211-24u

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

  • Ssp DQB1*06 Ref 101.212-24u

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

  • Ssp Hla-B*07 Ref 101.512-03u

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

  • Ssp Hla-C*14 Ref 101.625-06u

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

  • Olerup QTYPE 11 Ref 201.701-03

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

  • Ssp DRB1*14 Ref 101.117-12u

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

  • Ssp DQB1*03 Ref 101.124-06u

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

  • Ssp Hla-A*24 Ref 101.422-24U

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

  • Ssp DRB1*07 Ref 101.118-24u

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

  • Ssp Hla-B*37 Ref 101.541-06u

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

  • Ssp Hla-B*14 Ref 101.524-12u

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

  • SSP DQB1 high Ref 101.221-12u

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

  • SSP HLA C high Ref 101.707-12u

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

  • Ssp Hla-C*04 Ref 101.612-12u

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

  • Ssp DPA1 Ref 101.331-24u

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

  • Ssp DRB5 Ref 101.123-24u

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

  • Ssp Hla-B*44 Ref 101.563-03u

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

  • Ssp Hla-A*68 Ref 101.418-12u

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

  • Ssp Hla-A*69 Ref 101.435-06u

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

  • SSP KIR Genotyping Ref 104.101-12u

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

  • Ssp Hla-B*40 Ref 101.523-03u

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

  • Ssp Hla-C*07 Ref 101.615-24u

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

  • Ssp DQB1*03 Ref 101.214-24u

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

  • Ssp Hla-C*15 Ref 101.626-12u

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

  • Ssp Hla-B*39 Ref 101.566-04u

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

Rows 1-50 of 185

Showing 1-50 of 185

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
SE-MF-000040995
FDA FEI number
3002522915
DUNS number
558836388
EU VAT number
SE556550725701
EUDAMED status
Active
EUDAMED registered name
CareDx AB
Registered address
5, Franzéngatan, 112 51, Stockholm, Sweden
PRRC contact
Maria Ilar(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredIVDR 1next expiry 23 Sep 2030

EUDAMED certificates (1)

TÜV Rheinland LGA Products GmbH 0197 1 certificate

  • HX 7091956-1 Active Supplemented

    Quality management system EU IVDR

    Issued
    18 Sep 2026
    Expires
    23 Sep 2030
    Reason
    Add device or group

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Caredx, Inc. BRISBANE, CA · US FEI 3005225997

Frequently asked questions

How many devices does CareDx AB have in the registry?

The registry currently lists 185 devices for CareDx AB. Devices recorded under merged duplicate company entries are counted once.

Which registries list CareDx AB's devices?

Among its 50 most recently registered devices, CareDx AB has devices listed in EUDAMED (50 devices) and FDA GUDID (40 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do CareDx AB's devices fall under?

Among its 50 most recently registered devices, the classes recorded for CareDx AB's devices are IVDR Class A, IVDR Class C, IVD general and IVD Annex II List B. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for CareDx AB?

EUDAMED lists 1 certificate for CareDx AB (quality management system) under IVDR. The most recent was issued on 18 Sep 2026.

What are the newest devices from CareDx AB in the registry?

The most recently registered devices listed for CareDx AB include AlloSeq Tx, Olerup QTYPE LC480 II Cal Plate, AlloSeq cfDNA and AlloSeq HCT.

Which FDA establishments are linked to CareDx AB?

1 FDA establishment is linked to CareDx AB in the registry; they are listed on the company page.

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