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489 device results listed.

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VIDAS® Anti-CHIKUNGUNYA IgM

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026610340
Basic UDI-DI: 357302BUDI000920TV
Reference: 423229
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:58

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NTM Elite agar

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026608996
Basic UDI-DI: 357302BUDI000866UG
Reference: 542431
EMDN: W0104010405
EMDN description: NON-CHROMOGENIC MEDIA (PLATES)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:58

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VIDAS® TB-IGRA

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026608576
Basic UDI-DI: 357302BUDI000853U7
Reference: 423111
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:58

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VIDAS® DENGUE NS1 Ag

IVD Class CIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026608217
Basic UDI-DI: 357302BUDI000852U5
Reference: 423077
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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ETEST® Delafloxacin (DFX)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026603205
Basic UDI-DI: 357302BUDI000812TR
Reference: 540252
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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VIDAS® PTH (1-84)

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026601560
Basic UDI-DI: 357302BUDI000860U4
Reference: 422010
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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ETEST® Meropenem/Vaborbactam (MEV)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026563578
Basic UDI-DI: 357302BUDI000810TM
Reference: 8310236
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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ETEST® Piperacillin/Tazobactam (P/T)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026563509
Basic UDI-DI: 357302BUDI000756U8
Reference: 8310247
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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VITEK® MS CHCA

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026556662
Basic UDI-DI: 357302BUDI000888US
Reference: 8309837
EMDN: W02039085
EMDN description: VARIOUS MICROBIOLOGY INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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VITEK® MS FA

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026555559
Basic UDI-DI: 357302BUDI000889UU
Reference: 8309836
EMDN: W02039085
EMDN description: VARIOUS MICROBIOLOGY INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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VIDAS® NEPHROCHECK®

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026554903
Basic UDI-DI: 357302BUDI000859UK
Reference: 421172
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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ETEST® Amoxicillin/clavulanic acid (2/1) (XL)

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026551124
Basic UDI-DI: 357302BUDI000761TZ
Reference: 8309069
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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ETEST® Ertapenem (ETP)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026550486
Basic UDI-DI: 357302BUDI000750TU
Reference: 8309005
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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ETEST® Moxifloxacin (MX)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026550424
Basic UDI-DI: 357302BUDI000745U3
Reference: 8308999
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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ETEST® Quinupristin/Dalfopristin (QDA)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026550417
Basic UDI-DI: 357302BUDI000754U4
Reference: 8308998
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

ETEST® Itraconazole (IT)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026550363
Basic UDI-DI: 357302BUDI000787UK
Reference: 8308993
EMDN: W010403060101
EMDN description: SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - MANUAL
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

ETEST® Trimethoprim (TR)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026550332
Basic UDI-DI: 357302BUDI000803TQ
Reference: 8308990
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

ETEST® Piperacillin (PP)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026550271
Basic UDI-DI: 357302BUDI000795UJ
Reference: 8308984
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

ETEST® Oxacillin (OX)

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026550257
Basic UDI-DI: 357302BUDI000752TY
Reference: 8308982
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

ETEST® Ofloxacin (OF)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026550240
Basic UDI-DI: 357302BUDI000794UG
Reference: 8308981
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details