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342 device results listed.

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GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit

CDX-160

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-160-01-20UMC
Basic UDI-DI: B-CDX-160-01-20UMC
Reference: CDX-160-01-20
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra® SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit

CDX-160

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-160-01-20NA
Basic UDI-DI: B-CDX-160-01-20NA
Reference: CDX-160-01-20
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit

CDX-160

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-160-01-100UGV
Basic UDI-DI: B-CDX-160-01-100UGV
Reference: CDX-160-01-100
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra® SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit

CDX-160

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-160-01-100JX
Basic UDI-DI: B-CDX-160-01-100JX
Reference: CDX-160-01-100
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra SARS-CoV-2, Flu A/B + RSV Assay Kit

CDX-140

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-140-01-40UL8
Basic UDI-DI: B-CDX-140-01-40UL8
Reference: CDX-140-01-40
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra® SARS-CoV-2, Flu A/B + RSV Assay Kit

CDX-140

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-140-01-40MA
Basic UDI-DI: B-CDX-140-01-40MA
Reference: CDX-140-01-40
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra SARS-CoV-2, Flu A/B + RSV Assay Kit

CDX-140

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-140-01-20UKW
Basic UDI-DI: B-CDX-140-01-20UKW
Reference: CDX-140-01-20
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra SARS-CoV-2, Flu A/B + RSV Assay Kit

CDX-140

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-140-01-100UF3
Basic UDI-DI: B-CDX-140-01-100UF3
Reference: CDX-140-01-100
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra® SARS-CoV-2, Flu A/B + RSV Assay Kit

CDX-140

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-140-01-100HH
Basic UDI-DI: B-CDX-140-01-100HH
Reference: CDX-140-01-100
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

08800111722141

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722141
Basic UDI-DI: 88001117IPBA01MA03WR
Reference: 11FLU30A
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 12.07.2026 11:37

Manufacturer products Authorised representative products Authorised representative actors View details

08800111722158

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722158
Basic UDI-DI: 88001117IPBA01MA03WR
Reference: 11FLU30A
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 12.07.2026 11:37

Manufacturer products Authorised representative products Authorised representative actors View details

Real SARS-CoV-2/Flu/RSV

5.237.XXX.88.ZZZ

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295775237XEGW
Basic UDI-DI: B-84295775237XEGW
Reference: 5.237.XXX.88.ZZZ
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

D-81649002AFR01EJB5

AFR01-AHG48E; AFR01-AHG96E; AFR01D-AHG48E; AFR01D-AHG96E