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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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01.08.2026 05:11

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Active filter:Manufacturer SRN:SE-MF-000002020

22 device results listed.

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Xpert®

Xpert® MTB/XDR

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940007515
Basic UDI-DI: B-07332940007515
Reference: GXMTB/XDR-10
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:56

Manufacturer products View details

Xpert®

Xpert® HIV-1 Qual XC

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940007461
Basic UDI-DI: B-07332940007461
Reference: GXHIV-QA-XC-CE-10
EMDN: W0105030107
EMDN description: HIV 1 - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:56

Manufacturer products View details

Xpert®

Xpert® HIV-1 Viral Load XC

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940007409
Basic UDI-DI: B-07332940007409
Reference: GXHIV-VL-XC-CE-10
EMDN: W0105030107
EMDN description: HIV 1 - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:56

Manufacturer products View details

Xpert®

Xpert® MRSA/SA Blood Culture

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940007140
Basic UDI-DI: B-07332940007140
Reference: GXMRSA/SABC-CE-10
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:56

Manufacturer products View details

Xpert®

Xpert® CT/NG

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940007058
Basic UDI-DI: B-07332940007058
Reference: GXCT/NGX-CE-120
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:56

Manufacturer products View details

Xpert®

Xpert® CT/NG

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940007041
Basic UDI-DI: B-07332940007041
Reference: GXCT/NGX-CE-10
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:56

Manufacturer products View details

Xpert®

Xpert® HCV VL Fingerstick

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940006433
Basic UDI-DI: B-07332940006433
Reference: GXHCV-FS-CE-10
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® HBV Viral Load

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940002480
Basic UDI-DI: B-07332940002480
Reference: GXHBV-VL-CE-10
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® MRSA /SA SSTI

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940002473
Basic UDI-DI: B-07332940002473
Reference: GXMRSA/SA-SSTI-CE
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® C. difficile BT

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940002299
Basic UDI-DI: B-07332940002299
Reference: GXCDIFFBT-CE-10
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® MTB/RIF Ultra

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940002138
Basic UDI-DI: B-07332940002138
Reference: GXMTB/RIF-ULTRA-50
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® MTB/RIF Ultra

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940002121
Basic UDI-DI: B-07332940002121
Reference: GXMTB/RIF-ULTRA-10
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® SA Nasal Complete

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940001889
Basic UDI-DI: B-07332940001889
Reference: GXSACOMP-CE-10
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® CT/NG

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940001919
Basic UDI-DI: B-07332940001919
Reference: GXCT/NG-CE-120
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® HCV Viral Load

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940001544
Basic UDI-DI: B-07332940001544
Reference: GXHCV-VL-CE-10
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® HPV

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940001179
Basic UDI-DI: B-07332940001179
Reference: GXHPV-CE-10
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® Norovirus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940000981
Basic UDI-DI: B-07332940000981
Reference: GXNOV-CE-10
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® vanA/vanB

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940000226
Basic UDI-DI: B-07332940000226
Reference: GXVANA/B-CE-10
EMDN: W0104080604
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® CT/NG

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940000073
Basic UDI-DI: B-07332940000073
Reference: GXCT/NG-CE-10
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® C.difficile

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940000011
Basic UDI-DI: B-07332940000011
Reference: GXCDIFFICILE-CE-10
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details