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RAPIDEC® CARBA NP

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026433659
Basic UDI-DI: 357302BUDI000749UB
Reference: 415418
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

VITEK® 2 AST-N421

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

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026625580
Basic UDI-DI: 357302BUDI000025SS
Reference: 543081
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ETEST® Mecillinam (MM)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026625085
Basic UDI-DI: 357302BUDI000699UM
Reference: 543055
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:55

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ETEST® Gentamicin (GM)

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026624835
Basic UDI-DI: 357302BUDI000696UF
Reference: 543030
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:55

Manufacturer products View details

VITEK® 2 AST-N404

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

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026617363
Basic UDI-DI: 357302BUDI000691U5
Reference: 542727
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

VITEK® 2 AST-P663

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

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026616885
Basic UDI-DI: 357302BUDI000690U3
Reference: 542707
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

VITEK® 2 AST-N403

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026616861
Basic UDI-DI: 357302BUDI000689UJ
Reference: 542706
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

VITEK® 2 AST-N402

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

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026616847
Basic UDI-DI: 357302BUDI000688UG
Reference: 542705
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

VITEK® 2 AST-N395

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

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026615819
Basic UDI-DI: 357302BUDI000678UD
Reference: 542603
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

VITEK® 2 AST-N386

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

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026610630
Basic UDI-DI: 357302BUDI000656U3
Reference: 542466
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

XYL

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026588748
Basic UDI-DI: 357302BUDI000283TJ
Reference: 541070
EMDN: W0104080599
EMDN description: MANUAL SUSCEPTIBILITY TESTING - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:54

Manufacturer products View details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026588731
Basic UDI-DI: 357302BUDI000132SU
Reference: 541069
EMDN: W0104080599
EMDN description: MANUAL SUSCEPTIBILITY TESTING - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:54

Manufacturer products View details

API® 50 CHB/E Medium

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026588724
Basic UDI-DI: 357302BUDI000272TD
Reference: 541068
EMDN: W0104080299
EMDN description: MANUAL IDENTIFICATION - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:53

Manufacturer products View details

API® 50 CHL Medium

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026588717
Basic UDI-DI: 357302BUDI000271TB
Reference: 541067
EMDN: W0104080299
EMDN description: MANUAL IDENTIFICATION - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:53

Manufacturer products View details

API® 50 CH

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026588694
Basic UDI-DI: 357302BUDI000270T9
Reference: 541065
EMDN: W0104080299
EMDN description: MANUAL IDENTIFICATION - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:53

Manufacturer products View details

API® M Medium

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026588687
Basic UDI-DI: 357302BUDI000572TU
Reference: 541064
EMDN: W0104080299
EMDN description: MANUAL IDENTIFICATION - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:53

Manufacturer products View details

RAPID ID 32 E

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026588649
Basic UDI-DI: 357302BUDI000098TM
Reference: 541060
EMDN: W0104080201
EMDN description: GRAM NEGATIVE - MANUAL IDENTIFICATION
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:53

Manufacturer products View details

API® OF Medium

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026588670
Basic UDI-DI: 357302BUDI000571TS
Reference: 541063
EMDN: W0104080299
EMDN description: MANUAL IDENTIFICATION - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:53

Manufacturer products View details

RAPID ID 32 STREP

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026588625
Basic UDI-DI: 357302BUDI000253T9
Reference: 541058
EMDN: W0104080203
EMDN description: GRAM POSITIVE - MANUAL IDENTIFICATION
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:53

Manufacturer products View details

ID 32 STAPH

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026588601
Basic UDI-DI: 357302BUDI000097TK
Reference: 541056
EMDN: W0104080203
EMDN description: GRAM POSITIVE - MANUAL IDENTIFICATION
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:53

Manufacturer products View details