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Cepheid AB

Active in EUDAMED

Swedenfrom SRN EUDAMED FDA SRN SE-MF-000002020 FEI 3009613136

Part of Cepheid

Devices
21
Registrations
EUDAMEDFDA
FDA recalls
0

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 FEI

Catalogue21

Newest first, rows 1-21 of 21

Search and filter all 21 devices
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  • Xpert® Ref GXGI-CE-10

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Xpert® Ref GXVANA/B-CE-10

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

  • Xpert® Ref GXMTB/XDR-10

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

  • Xpert® Ref GXCDIFFBT-CE-10

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

  • Xpert® Ref GXCT/NGX-CE-120

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

  • Xpert® Ref GXHBV-VL-CE-10

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

  • Xpert® Ref GXCT/NG-CE-10

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

  • Xpert® Ref GXHPV-CE-10

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

  • Xpert® Ref GXNOV-CE-10

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

  • Xpert® Ref GXCT/NGX-CE-10

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

  • Xpert® Ref GXMTB/RIF-ULTRA-10

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

  • Xpert® Ref GXMTB/RIF-ULTRA-50

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

  • Xpert® Ref GXCDIFFICILE-CE-10

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

  • Xpert® Ref GXHIV-QA-XC-CE-10

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

  • Xpert® Ref GXSACOMP-CE-10

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

  • Xpert® Ref GXHCV-FS-CE-10

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

  • Xpert® Ref GXHCV-VL-CE-10

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

  • Xpert® Ref GXMRSA/SABC-CE-10

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

  • Xpert® Ref GXCT/NG-CE-120

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

  • Xpert® Ref GXMRSA/SA-SSTI-CE

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

  • Xpert® Ref GXMRSA/SA-BC-CE-10

    Withdrawn Regimes: CE IVDD, withdrawn Registry: EUDAMED Class:IVD General

Rows 1-21 of 21

Company details

EUDAMED SRN
SE-MF-000002020
FDA FEI number
3009613136
EU VAT number
SE556595618101
EUDAMED status
Active since 2024
EUDAMED registered name
Cepheid AB
Registered address
5, Röntgenvägen, SE-171 54, Solna, Sweden
Phone
+46 8 684 370 00
PRRC contact
Helena Sedlenieks(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredIVDR 1next expiry 5 Aug 2029

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • IVDR 793827 Active Supplemented

    Technical documentation EU IVDR

    Issued
    10 Sep 2026
    Expires
    5 Aug 2029
    Reason
    Change approved

Frequently asked questions

How many devices does Cepheid AB have in the registry?

The registry currently lists 21 devices for Cepheid AB. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cepheid AB's devices?

Among its 21 most recently registered devices, Cepheid AB has devices listed in EUDAMED (21 devices).

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

Among its 21 most recently registered devices, the classes recorded for Cepheid AB's devices are IVDR Class B, IVD general, IVD Annex II List A and IVD Annex II List B. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Cepheid AB?

EUDAMED lists 1 certificate for Cepheid AB (technical documentation) under IVDR. The most recent was issued on 10 Sep 2026.

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

The most recently registered devices listed for Cepheid AB include Xpert®.

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