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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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27.07.2026 01:11

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Active filter:Manufacturer SRN:US-MF-000010979

34 device results listed.

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Xpert® Xpress SARS-CoV-2

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940009526
Basic UDI-DI: B-07332940009526
Reference: XPRSARS-COV2-10
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® NPM1 Mutation

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940008390
Basic UDI-DI: B-07332940008390
Reference: GXNPM1-CE-10
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Xpress CoV-2/Flu/RSV plus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940008000
Basic UDI-DI: B-07332940008000
Reference: XP3COV2/FLU/RSV-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Xpress CoV-2 plus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940007928
Basic UDI-DI: B-07332940007928
Reference: XP3SARS-COV2-10
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Carba-R

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940006525
Basic UDI-DI: B-07332940006525
Reference: GXCARBARP-CE-120
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Carba-R

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940006518
Basic UDI-DI: B-07332940006518
Reference: GXCARBARP-CE-10
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Xpress Flu/RSV

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940002329
Basic UDI-DI: B-07332940002329
Reference: XPRSFLU/RSV-CE-10
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Bladder Cancer Monitor

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940002282
Basic UDI-DI: B-07332940002282
Reference: GXBLAD-CM-CE-10
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Bladder Cancer Detection

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940002268
Basic UDI-DI: B-07332940002268
Reference: GXBLAD-CD-CE-10
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Carba-R

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940002015
Basic UDI-DI: B-07332940002015
Reference: GXCARBAR-CE-120
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® MRSA NxG

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940001704
Basic UDI-DI: B-07332940001704
Reference: GXMRSA-NXG-CE-120
EMDN: W0104080602
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED MRSA AND/OR MSSA
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® MRSA NxG

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940001698
Basic UDI-DI: B-07332940001698
Reference: GXMRSA-NXG-CE-10
EMDN: W0104080602
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED MRSA AND/OR MSSA
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Carba-R

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940001049
Basic UDI-DI: B-07332940001049
Reference: GXCARBAR-CE-10
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® TV

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940001018
Basic UDI-DI: B-07332940001018
Reference: GXTV-CE-10
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® FII & FV

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940000240
Basic UDI-DI: B-07332940000240
Reference: GXFIIFV-10
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GeneXpert® Infinity Systems

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940007713
Basic UDI-DI: 081164701-INFINITY-ZH
Reference: GX-INFINITY 48S
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

GeneXpert® Dx Systems

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940007683
Basic UDI-DI: 081164701-GX-X5
Reference: GeneXpert II (GX-II)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Swab Specimen Collection Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940007003
Basic UDI-DI: 081164701-SWAB/G-43
Reference: SWAB/G-50
EMDN: A1102
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Nasal Sample Collection Kit

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940006457
Basic UDI-DI: 081164701-SWAB/F-3Y
Reference: SWAB/F-100
EMDN: A1102
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Netherlands
Authorised representative: Cepheid Europe S.A.S.
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® FFPE Lysis Kit

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940006013
Basic UDI-DI: 081164701-GXFFPE-LYSIS-MP
Reference: GXFFPE-LYSIS-CE-10
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details