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ATB™ DENSITOMETER CONTROL KIT

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026040949
Basic UDI-DI: 357302BUDI000212ST
Reference: 15512
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:47

Manufacturer products View details

API® Candida

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026035693
Basic UDI-DI: 357302BUDI000207T2
Reference: 10500
EMDN: W0104030405
EMDN description: IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - MANUAL
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:47

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API® NH

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026035600
Basic UDI-DI: 357302BUDI000605TJ
Reference: 10400
EMDN: W0104080201
EMDN description: GRAM NEGATIVE - MANUAL IDENTIFICATION
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:47

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API® LISTERIA

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026035587
Basic UDI-DI: 357302BUDI000036SX
Reference: 10300
EMDN: W0104080299
EMDN description: MANUAL IDENTIFICATION - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:47

Manufacturer products View details

EMAG® SOFTWARE V1.4

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026635046
Basic UDI-DI: 357302BUDI002042T8
Reference: 424651
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 29.07.2026 22:53

Manufacturer products View details

VITEK® MS-DS

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026554224
Basic UDI-DI: 357302BUDI000887UQ
Reference: 8309615
EMDN: W02039085
EMDN description: VARIOUS MICROBIOLOGY INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 29.07.2026 22:53

Manufacturer products View details

CHROMID® ESBL / CHROMID VRE

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026600761
Basic UDI-DI: 357302BUDI000126SZ
Reference: 542272
EMDN: W0104010402
EMDN description: CHROMOGENIC ID MEDIA (PLATES)
First on market country: France
Authorised representative: -
Last updated: 24.07.2026 22:55

Manufacturer products View details

chromID® OXA-48 Agar

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026600358
Basic UDI-DI: 357302BUDI000160SZ
Reference: 542231
EMDN: W0104010402
EMDN description: CHROMOGENIC ID MEDIA (PLATES)
First on market country: France
Authorised representative: -
Last updated: 23.07.2026 22:43

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Mueller Hinton agar with 5% horse blood + 20 mg/L β-NAD

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026600112
Basic UDI-DI: 357302BUDI000018SV
Reference: 542207
EMDN: W0104010403
EMDN description: SUSCEPTIBILITY TEST MEDIA (PLATES)
First on market country: France
Authorised representative: -
Last updated: 23.07.2026 22:43

Manufacturer products View details

NUCLISENS® Lysis Buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026596170
Basic UDI-DI: 357302BUDI000601TA
Reference: 541813
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: -
Last updated: 22.07.2026 00:46

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VITEK® 2 AST-P674

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026642082
Basic UDI-DI: 357302BUDI002258TZ
Reference: 543661
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

Color Gram 2 (COLOR GRAM 2 R3-F)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026623463
Basic UDI-DI: 357302BUDI000276TM
Reference: 423963
EMDN: W0104010804
EMDN description: STAINS
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

VITEK® 2 AST-N399

IVD Class BIVDR 2017/746Not intended for EU marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026621537
Basic UDI-DI: 357302BUDI000879UR
Reference: 542861
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

VIDAS® Cortisol S

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026620936
Basic UDI-DI: 357302BUDI000248TG
Reference: 30451-30
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

MUELLER HINTON CLOXA agar

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026611644
Basic UDI-DI: 357302BUDI000196TN
Reference: 542471
EMDN: W0104010403
EMDN description: SUSCEPTIBILITY TEST MEDIA (PLATES)
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

CHROMID® MRSA Agar

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026611620
Basic UDI-DI: 357302BUDI000125SX
Reference: 542469
EMDN: W0104010402
EMDN description: CHROMOGENIC ID MEDIA (PLATES)
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

VITEK® MS PRIME

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026611422
Basic UDI-DI: 357302BUDI000913TY
Reference: 423281
EMDN: W020303
EMDN description: MASS - SPECTROMETRY SYSTEM
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

VIDAS® Anti-DENGUE IgG

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026608248
Basic UDI-DI: 357302BUDI000627TU
Reference: 423079
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

VIDAS® Anti-DENGUE IgM

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026608224
Basic UDI-DI: 357302BUDI000626TS
Reference: 423078
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

Sabouraud Gentamicin Chloramphenicol 2 Agar

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026600860
Basic UDI-DI: 357302BUDI000128T5
Reference: 542282
EMDN: W0104030201
EMDN description: PPM FOR YEASTS AND FUNGI
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details