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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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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® 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

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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

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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

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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

Femoflor® 16 REAL-TIME PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014360048
Basic UDI-DI: B-04660014360048
Reference: R1-P801-S3/6EU
EMDN: W0104080601
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 17:34

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Dischi Impregnati

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Microbiol S.r.l.
Manufacturer SRN: IT-MF-000052547
UDI-DI: 08057920720862
Basic UDI-DI: 8057920MICANTDISCHILL
Reference: MICOP5-50
EMDN: W0104080502
EMDN description: IMPREGNATED DISKS, MULTI-DISKS & TABLETS
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 12:09

Manufacturer products View details

COAGULASE PLASMA EDTA - 4 fl x 7,5mL

IVD FOR MICROBIAL IDENTIFICATION

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Biolife Italiana s.r.l.
Manufacturer SRN: IT-MF-000018174
UDI-DI: 08054187132391
Basic UDI-DI: 805418713MICROIDENTIFICKJ
Reference: 429937
EMDN: W0104080299
EMDN description: MANUAL IDENTIFICATION - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 12:00

Manufacturer products View details

Adult type, infant type(pediatric type), mother-child type，Write-on type, insert-card type, Auto Printable. Thermal Printing

Class IMDR 2017/745On the marketSingle use

Manufacturer: SHANGHAI SUNSHORE MEDICAL INSTRUMENTS CO.,LTD
Manufacturer SRN: CN-MF-000056183
UDI-DI: 06980231236031
Basic UDI-DI: 698023123IDB00138
Reference: Adult type
EMDN: W0104080299
EMDN description: MANUAL IDENTIFICATION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 11:30

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Gram Negative bacteria AST (MALDI-TOF MS)

Automated Mass Spectrometry Microbial Identification System

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359511209
Basic UDI-DI: 697015090000367HX
Reference: MS0301
EMDN: W0104080109
EMDN description: COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM NEGATIVES - AUTOMATED
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

Gram Positive bacteria AST (MALDI-TOF MS)

Automated Mass Spectrometry Microbial Identification System（Autof）

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359511179
Basic UDI-DI: 697015090000366HV
Reference: MS0201
EMDN: W0104080110
EMDN description: COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM POSITIVES - AUTOMATED
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 10:46

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Sensititre™ IRBP11F

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384565740
Basic UDI-DI: 5032384IRBP11FKY
Reference: Sensititre™ IRBP11F
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 16.07.2026 09:45

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Gram Positive MIC Kit, Plate - Packaged (SIW)

Sensititre™ ARGPF

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384549580
Basic UDI-DI: 5032384ARGPFQB
Reference: ARGPF
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 16.07.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

Sensititre™ SEMSE7

IVD Class BIVDR 2017/746On the marketAnimal tissuesReagentSingle use

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384546381
Basic UDI-DI: 5032384SEMSE7RP
Reference: SENSITITRE SUSCEPTIBILITY NON-FASTIDIOUS GRAM POSITIVE
EMDN: W0104080599
EMDN description: MANUAL SUSCEPTIBILITY TESTING - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 16.07.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

Sensititre™ THAPF

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384545971
Basic UDI-DI: 5032384THAPFTQ
Reference: Gram Positive MIC Kit, Plate - Packaged (SIW)
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 16.07.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

Sensititre Susceptibility MIC / BP Gram Positive Panel

Sensititre™ GPALL1F

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384474356
Basic UDI-DI: 5032384GPALL1FLX
Reference: GPALL1F
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 16.07.2026 09:45

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BD Phoenix™ NMIC/ID-470

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904497249
Basic UDI-DI: 038290ZQMKCSAVNN
Reference: 449724
EMDN: W0104080109
EMDN description: COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM NEGATIVES - AUTOMATED
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:50

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BD Phoenix™ NMIC-474

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904497270
Basic UDI-DI: 038290UVBZIPVLR8
Reference: 449727
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:50

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BD Phoenix™ NMIC-451

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904494729
Basic UDI-DI: 038290SQRKDGOCJZ
Reference: 449472
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:50

Manufacturer products Authorised representative products Authorised representative actors View details