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81 device results listed.

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GenomEra HSV 1/2, VZV + EV Assay Kit

CDX-170

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-170-01-40P3
Basic UDI-DI: B-CDX-170-01-40P3
Reference: CDX-170-01-40
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 HSV 1/2, VZV + EV Assay Kit

CDX-170

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-170-01-20UN3
Basic UDI-DI: B-CDX-170-01-20UN3
Reference: CDX-170-01-20
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 HSV 1/2, VZV + EV Assay Kit

CDX-170

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-170-01-20NV
Basic UDI-DI: B-CDX-170-01-20NV
Reference: CDX-170-01-20
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-160-01-20UMC
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

Fluorion

Fluorion Covidenza Plus QLP 3.0 Real-Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898741055
Basic UDI-DI: B-08698898741055
Reference: M1390102
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 15:00

Manufacturer products View details

Fluorion

Fluorion Covidenza Plus QLP 2.0 Real-Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898741048
Basic UDI-DI: B-08698898741048
Reference: M1380102
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 15:00

Manufacturer products View details

Fluorion

Fluorion Covidenza Plus QLP 1.0 Real-Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898741031
Basic UDI-DI: B-08698898741031
Reference: M1370102
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 15:00

Manufacturer products View details

Fluorion

Fluorion Covidenza QLP 1.0 Real-Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898741000
Basic UDI-DI: B-08698898741000
Reference: M1360102
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 15:00

Manufacturer products View details

06975578360303

HHV

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360303
Basic UDI-DI: B-06975578360303
Reference: 2000262
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

06975327120592

SARS-CoV-2/Influenza A/Influenza B/RSV Nucleic Acid Test Card

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120592
Basic UDI-DI: B-06975327120592
Reference: RM1011702-10
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details