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VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217480
Basic UDI-DI: 84354402_MDXRESP_HSMYH
Reference: VS-HSM101E
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 22:54

Manufacturer products View details

VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217497
Basic UDI-DI: 84354402_MDXRESP_HSMYH
Reference: VS-HSM136E
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 22:54

Manufacturer products View details

VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217503
Basic UDI-DI: 84354402_MDXRESP_HSMYH
Reference: VS-HSM172E
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 22:54

Manufacturer products View details

U-CardDx™ 200

6 Types of Diarrhea Pathogens Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289854047
Basic UDI-DI: B-06933289854047
Reference: WR90P0003
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx Acinetobacter baumannii qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717479
Basic UDI-DI: B-08683079717479
Reference: IP202206-100
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 05.08.2026 15:03

Manufacturer products View details

Nucleic Acid Detection Kit for Seven respiratory pathogens (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870408
Basic UDI-DI: B-06974081870408
Reference: CFPD003
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:44

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Influenza A Virus, Influenza B Virus and Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870385
Basic UDI-DI: B-06974081870385
Reference: RTI001
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus Combo Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140242
Basic UDI-DI: B-06958982140242
Reference: AH50-20
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Estonia
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atlas

8.04.74.0.0025

IVD generalIVDDOn the marketAnimal tissuesProfessional testingSingle use

Manufacturer: Atlas Medical GmbH
Manufacturer SRN: DE-MF-000029961
UDI-DI: 04262408512462
Basic UDI-DI: B-04262408512462
Reference: 8.04.74.0.0025
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:43

Manufacturer products View details

SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 03664965001044
Basic UDI-DI: B-03664965001044
Reference: ISIN-525H
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE Salmonella, Campylobacter & Y. enterocolitica 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: 08435440202349
Basic UDI-DI: 84354402_MDXGASTROB_SCYT3
Reference: VS-SCY106L
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 22:38

Manufacturer products View details

D-90089-RTGA

EliGene® STD GAR/URE/MYC RT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ELISABETH PHARMACON, spol. s r.o.
Manufacturer SRN: CZ-MF-000025244
UDI-DI: D-90089-RTGA
Basic UDI-DI: B-90089-RTGA
Reference: 90089-RT
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 04.08.2026 19:28

Manufacturer products View details

PCR-Box Resistance

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730763
Basic UDI-DI: B-09120127730763
Reference: 09120127730763
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

PCR-Box Fungi 48rx-s

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730732
Basic UDI-DI: B-09120127730732
Reference: 09120127730732
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

PCR-Box Bacteria 48rx-s

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730725
Basic UDI-DI: B-09120127730725
Reference: 09120127730725
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

PCR-Box IPC

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730114
Basic UDI-DI: B-09120127730114
Reference: 09120127730114
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

PCR-Box Resistance

IVD generalIVDDNo longer on the marketProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730107
Basic UDI-DI: B-09120127730107
Reference: 09120127730107
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

PCR-Box Fungi

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730091
Basic UDI-DI: B-09120127730091
Reference: 09120127730091
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

PCR-Box Bacteria

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730084
Basic UDI-DI: B-09120127730084
Reference: 09120127730084
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

hybcell Pathogens DNA xB

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730077
Basic UDI-DI: B-09120127730077
Reference: 09120127730077
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details