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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Active filter:Manufacturer SRN:US-MF-000003311

16 device results listed.

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FilmArray® Meningitis/Encephalitis (ME) Panel

IVD Class CNot specifiedOn the market

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020130
Basic UDI-DI: 357302BUDI000004SJ
Reference: RFIT-ASY-0119
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: bioMérieux SA
Last updated: 22.09.2026 02:24

Manufacturer products Authorised representative products Authorised representative actors View details

BioFire® Blood Culture Identification 2 (BCID2) Panel

IVD Class CNot specifiedOn the market

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020345
Basic UDI-DI: 357302BUDI000001SC
Reference: RFIT-ASY-0148
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: bioMérieux SA
Last updated: 22.09.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

SpotFire®

IVD Class ANot specifiedOn the market

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020055
Basic UDI-DI: 357302BUDI000917U8
Reference: FAST-ASY-0001
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: bioMérieux SA
Last updated: 22.09.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

BIOFIRE® FILMARRAY® Pneumonia Panel plus

IVD Class DNot specifiedOn the market

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020314
Basic UDI-DI: 357302BUDI002137TL
Reference: RFIT-ASY-0143
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: bioMérieux SA
Last updated: 22.09.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

BioFire® Respiratory Panel 2.1 plus (RP2.1 plus)

IVD Class DNot specifiedOn the market

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020505
Basic UDI-DI: 357302BUDI000002SE
Reference: 423740
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: bioMérieux SA
Last updated: 22.09.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

FilmArray® Gastrointestinal (GI) Panel

IVD Class BNot specifiedOn the market

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020109
Basic UDI-DI: 357302BUDI000005SL
Reference: RFIT-ASY-0116
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: bioMérieux SA
Last updated: 22.09.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

BioFire® Joint Infection (JI) Panel

IVD Class CNot specifiedOn the market

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020192
Basic UDI-DI: 357302BUDI000006SN
Reference: RFIT-ASY-0138
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: bioMérieux SA
Last updated: 22.09.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

BIOFIRE® FILMARRAY® Pneumonia Panel plus

IVD Class DNot specifiedOn the market

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020321
Basic UDI-DI: 357302BUDI002137TL
Reference: RFIT-ASY-0142
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: bioMérieux SA
Last updated: 22.09.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

FilmArray® Torch System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020253
Basic UDI-DI: 357302BUDI000922TZ
Reference: HTFA-ASY-0104
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.09.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details

FilmArray® 2.0 Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020031
Basic UDI-DI: 357302BUDI000020SG
Reference: FLM2-ASY-0001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel

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

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381021007
Basic UDI-DI: 357302BUDI002231TD
Reference: 424803
EMDN: W0105070506
EMDN description: TROPICAL FEVER - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 29.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SpotFire®

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020369
Basic UDI-DI: 357302BUDI000917U8
Reference: FAST-ASY-0002
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 29.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

BioFire® Blood Culture Identification 2 (BCID2) Panel

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

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020338
Basic UDI-DI: 357302BUDI000001SC
Reference: RFIT-ASY-0147
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 29.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

BioFire® Joint Infection (JI) Panel

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

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020208
Basic UDI-DI: 357302BUDI000006SN
Reference: RFIT-ASY-0135
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 29.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

FilmArray® Meningitis/Encephalitis (ME) Panel

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

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020123
Basic UDI-DI: 357302BUDI000004SJ
Reference: RFIT-ASY-0118
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 29.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

FilmArray® Gastrointestinal (GI) Panel

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

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020116
Basic UDI-DI: 357302BUDI000005SL
Reference: RFIT-ASY-0104
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 29.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details