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33 device results listed.

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Automated Microbiology System Analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359535403
Basic UDI-DI: 697015090000195HS
Reference: ME1201
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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Automated Microbiology System Analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359535373
Basic UDI-DI: 697015090000194HQ
Reference: ME1101
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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SENSITITRE EUSTA2F

SENSITITRE EUSTA2F

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384584451
Basic UDI-DI: 5032384EUSTA2FU8
Reference: EUSTA2F
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:06

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SENSITITRE EUENC2F

SENSITITRE EUENC2F

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384584468
Basic UDI-DI: 5032384EUENC2FNE
Reference: EUENC2F
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:06

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VITEK® 2 AST-P673

VITEK® 2 AST-P673

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

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026641870
Basic UDI-DI: 357302BUDI002255TT
Reference: 543653
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 21:02

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VITEK® 2 AST-P671

VITEK® 2 AST-P671

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

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026640163
Basic UDI-DI: 357302BUDI002241TG
Reference: 543572
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 21:02

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VITEK® 2 AST-P670

VITEK® 2 AST-P670

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

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026638450
Basic UDI-DI: 357302BUDI002192TU
Reference: 543539
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 21:02

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VITEK® 2 AST-P663

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-ST03

VITEK® 2 AST-ST03

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

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026554620
Basic UDI-DI: 357302BUDI000032SP
Reference: 8309563
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

VITEK® 2 AST-ST02

VITEK® 2 AST-ST02

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

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026554613
Basic UDI-DI: 357302BUDI000031SM
Reference: 8309562
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 20:53

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VITEK® 2 AST-P674

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

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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™ 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

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BD Phoenix™ PMIC-600

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

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904490554
Basic UDI-DI: 038290ZZIEDNMOPV
Reference: 449055
EMDN: W0104080108
EMDN description: GRAM POSITIVE 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

BD Phoenix™ PMIC-96

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

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904490097
Basic UDI-DI: 038290TJZPVNDDQW
Reference: 449009
EMDN: W0104080108
EMDN description: GRAM POSITIVE 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

BD Phoenix™ PMIC-88

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

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904487981
Basic UDI-DI: 038290VGJIVRNHHE
Reference: 448798
EMDN: W0104080108
EMDN description: GRAM POSITIVE 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

BD Phoenix™ PMIC-90

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

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904484393
Basic UDI-DI: 038290SOFWPSWRPD
Reference: 448439
EMDN: W0104080108
EMDN description: GRAM POSITIVE 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

BD Phoenix™ PMIC-89

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

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904484386
Basic UDI-DI: 038290OSMLDAIDEK
Reference: 448438
EMDN: W0104080108
EMDN description: GRAM POSITIVE 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

BD Phoenix™ PMIC-601

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

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904497263
Basic UDI-DI: 038290EVVYSTRVSK
Reference: 449726
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

BD Phoenix™ PMIC-603

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

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904495238
Basic UDI-DI: 038290GDOGDPSN4U
Reference: 449523
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details