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344 device results listed.

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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: 03573026137892
Basic UDI-DI: 357302BUDI000254TB
Reference: 42031
EMDN: W0104030301
EMDN description: TUBES FOR YEASTS AND FUNGI
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:50

Manufacturer products View details

Mycoline (MYCOLINE)

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026092405
Basic UDI-DI: 357302BUDI000497U7
Reference: 56525
EMDN: W0104030405
EMDN description: IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - MANUAL
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:49

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Sabouraud liquid broth

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026073664
Basic UDI-DI: 357302BUDI000473TR
Reference: 42108
EMDN: W0104030301
EMDN description: TUBES FOR YEASTS AND FUNGI
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:49

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Sabouraud Chloramphenicol Actidione Agar

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026073527
Basic UDI-DI: 357302BUDI000256TF
Reference: 42094
EMDN: W0104030301
EMDN description: TUBES FOR YEASTS AND FUNGI
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:49

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ID 32 C

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026066383
Basic UDI-DI: 357302BUDI000252T7
Reference: 32200
EMDN: W0104030405
EMDN description: IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - MANUAL
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

API® 20 C AUX

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026048082
Basic UDI-DI: 357302BUDI000215SZ
Reference: 20210
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

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

Manufacturer products View details

VITEK® 2 YST

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026529697
Basic UDI-DI: 357302BUDI000218T7
Reference: 8308128
EMDN: W0104030403
EMDN description: IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 22.07.2026 00:46

Manufacturer products Authorised representative products Authorised representative actors View details

MIC NEF

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Diagnostics s.r.o.
Manufacturer SRN: SK-MF-000038255
UDI-DI: D-7003AN
Basic UDI-DI: B-7003AN
Reference: 7003
EMDN: W010403060101
EMDN description: SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - MANUAL
First on market country: Slovakia
Authorised representative: -
Last updated: 22.07.2026 00:41

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

Dermatophyte Agar

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026600525
Basic UDI-DI: 357302BUDI000261T8
Reference: 542248
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

VITEK® 2 AST-YS10

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

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026649234
Basic UDI-DI: 357302BUDI002337TW
Reference: 543910
EMDN: W010403060102
EMDN description: SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 16.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Zdravotní ústav se sídlem v Ostravě
Manufacturer SRN: CZ-MF-000046342
UDI-DI: 08594224840051
Basic UDI-DI: 08594224840051SU
Reference: 006
EMDN: W0104030299
EMDN description: PREPARED MEDIA IN PLATES - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 06:56

Manufacturer products View details

Phoenix

BD Phoenix™ YEAST ID

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

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904483166
Basic UDI-DI: 038290JHJJQPLUAD
Reference: 448316
EMDN: W0104030403
EMDN description: IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

YEASTS WELL D-ONE

MS01289

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01289Q8
Basic UDI-DI: B-MS01289Q8
Reference: MS01289
EMDN: W0104030405
EMDN description: IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - MANUAL
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

Manufacturer products View details

RIDA®Plex Dermatophytes and other Fungi 12 well Step 1

RIDA®Plex Dermatophytes and other Fungi 12 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006388
Basic UDI-DI: B-09343044006388
Reference: 84115S
EMDN: W0104030404
EMDN description: IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI / NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Dermatophytes and other Fungi 12 well Step 2

RIDA®Plex Dermatophytes and other Fungi 12 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006371
Basic UDI-DI: B-09343044006371
Reference: 84115P
EMDN: W0104030404
EMDN description: IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI / NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

Dermatophytes and other Fungi 12-well

Step 1 tubes for Dermatophytes and other Fungi 12-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003349
Basic UDI-DI: B-09343044003349
Reference: 84115S
EMDN: W0104030404
EMDN description: IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI / NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dermatophytes and other Fungi 12-well

Step 2 Plates for Dermatophytes and other Fungi 12-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003332
Basic UDI-DI: B-09343044003332
Reference: 84115P
EMDN: W0104030404
EMDN description: IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI / NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

ChainFor Candida Auris Detection qPCR Kit

CFP97

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548256997
Basic UDI-DI: B-08683548256997
Reference: CFP97
EMDN: W0104030404
EMDN description: IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI / NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:14

Manufacturer products View details