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SARS-COV-2/FLUA/FLUB/RSV R-GENE®

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026631512
Basic UDI-DI: 357302BUDI002003SW
Reference: 424433
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:00

Manufacturer products View details

Rhino&EV/Cc R-GENE®

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026387990
Basic UDI-DI: 357302BUDI000034ST
Reference: 71-042
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

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ChainFor™

Ureaplasma urealyticum qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032404
Basic UDI-DI: 0868511580PCR1125W
Reference: CFP112P100
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 30.07.2026 20:22

Manufacturer products View details

Vaginal pH/Candida albicans/Trichomonas Vaginalis Combo Rapid Test

Vaginal pH/Candida albicans/Trichomonas vaginalis Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IVCT-535PG
Basic UDI-DI: B-IVCT-535PG
Reference: Vaginal pH/Candida albicans/Trichomonas vaginalis Combo Rapid Test
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 18:09

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

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

ChainFor™

STI ID-12 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548256904
Basic UDI-DI: 868499827PCR115YM
Reference: CFP115P100
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.07.2026 23:12

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VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440214410
Basic UDI-DI: 84354402_MDXRESP_CFRWT
Reference: VS-CFR106L
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 23:11

Manufacturer products View details

VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440202479
Basic UDI-DI: 84354402_MDXRESPB_ABR3Y
Reference: VS-ABR106L
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 23:11

Manufacturer products View details

ChainFor™

Ureaplasma urealyticum qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032411
Basic UDI-DI: 0868511580PCR1125W
Reference: CFP112P25
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.07.2026 23:02

Manufacturer products View details

VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217282
Basic UDI-DI: 84354402_MDXRESPB_ABR3Y
Reference: VS-ABR101L
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:54

Manufacturer products View details

VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217299
Basic UDI-DI: 84354402_MDXRESPB_ABR3Y
Reference: VS-ABR101H
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:54

Manufacturer products View details

VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440202509
Basic UDI-DI: 84354402_MDXRESPB_ABR3Y
Reference: VS-ABR106H
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:54

Manufacturer products View details

VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440202486
Basic UDI-DI: 84354402_MDXRESPB_ABR3Y
Reference: VS-ABR112L
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:54

Manufacturer products View details

VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440202516
Basic UDI-DI: 84354402_MDXRESPB_ABR3Y
Reference: VS-ABR112H
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:54

Manufacturer products View details

VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440202493
Basic UDI-DI: 84354402_MDXRESPB_ABR3Y
Reference: VS-ABR113L
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:54

Manufacturer products View details

VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440202523
Basic UDI-DI: 84354402_MDXRESPB_ABR3Y
Reference: VS-ABR113H
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:54

Manufacturer products View details

VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440209812
Basic UDI-DI: 84354402_MDXRESPB_ABR3Y
Reference: VS-ABR196T
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:54

Manufacturer products View details