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Chikungunya Fever IgG/IgM Antibody Test Kit (Colloidal Gold Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: D-CNMF000023810CFCR056MB
Basic UDI-DI: B-CNMF000023810CFCR056MB
Reference: CR056
EMDN: W0105040525
EMDN description: CHIKUNGUNYA VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:06

Manufacturer products Authorised representative products Authorised representative actors View details

GenomEra SARS-CoV-2 2.0 Assay Kit

CDX-150

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-150-01-20ULM
Basic UDI-DI: B-CDX-150-01-20ULM
Reference: CDX-150-01-20
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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GenomEra® SARS-CoV-2 2.0 Assay Kit

CDX-150

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-150-01-20MP
Basic UDI-DI: B-CDX-150-01-20MP
Reference: CDX-150-01-20
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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GenomEra SARS-CoV-2 2.0 Assay Kit

CDX-150

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-150-01-100UFY
Basic UDI-DI: B-CDX-150-01-100UFY
Reference: CDX-150-01-100
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra® SARS-CoV-2 2.0 Assay Kit

CDX-150

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-150-01-100J8
Basic UDI-DI: B-CDX-150-01-100J8
Reference: CDX-150-01-100
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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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-140Q9
Basic UDI-DI: B-CDX-140Q9
Reference: CDX-140-01-20
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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GenomEra® SARS-CoV-2 Assay Kit

CDX-130-01-20

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-130Q6
Basic UDI-DI: B-CDX-130Q6
Reference: CDX-130-01-20
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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GenomEra SARS-CoV-2 Assay Kit

CDX-130

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-130-01-40UKH
Basic UDI-DI: B-CDX-130-01-40UKH
Reference: CDX-130-01-40
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra® SARS-CoV-2 Assay Kit

CDX-130

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-130-01-40LP
Basic UDI-DI: B-CDX-130-01-40LP
Reference: CDX-130-01-40
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra SARS-CoV-2 Assay Kit

CDX-130

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-130-01-20UK7
Basic UDI-DI: B-CDX-130-01-20UK7
Reference: CDX-130-01-20
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra SARS-CoV-2 Assay Kit

CDX-130

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-130-01-100UE6
Basic UDI-DI: B-CDX-130-01-100UE6
Reference: CDX-130-01-100
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra® SARS-CoV-2 Assay Kit

CDX-130

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-130-01-100GS
Basic UDI-DI: B-CDX-130-01-100GS
Reference: CDX-130-01-100
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

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GenomEra Norovirus Assay kit

CDX-100

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-100-01-40UHC
Basic UDI-DI: B-CDX-100-01-40UHC
Reference: CDX-100-01-40
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra Norovirus Assay kit

CDX-100

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-100-01-40JW
Basic UDI-DI: B-CDX-100-01-40JW
Reference: CDX-100-01-40
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:58

Manufacturer products View details

GenomEra Norovirus Assay kit

CDX-100

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-100-01-20UH2
Basic UDI-DI: B-CDX-100-01-20UH2
Reference: CDX-100-01-20
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:58

Manufacturer products View details

GenomEra Norovirus Assay kit

CDX-100

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-100-01-20JQ
Basic UDI-DI: B-CDX-100-01-20JQ
Reference: CDX-100-01-20
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:58

Manufacturer products View details

Monkeypox Virus Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-AMPV01FJ
Basic UDI-DI: B-AMPV01FJ
Reference: AMPV01-AOG48E, AMPV01-AOG96E, AMPV01D-AOG48E, AMPV01D-AOG96E
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA HHV6 Quantitative PCR Test

300157, 300184, 300673, 300180

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395SSAHHV6QTT4A
Basic UDI-DI: B-888501395SSAHHV6QTT4A
Reference: 300157, 300184, 300180, 300673
EMDN: W0105040524
EMDN description: HHV-6,7,8 - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CRTIZK0154ZG

CRTIZK01-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CRTIZK0154ZG
Basic UDI-DI: B-81649002CRTIZK0154ZG
Reference: CRTIZK01-AHG4E
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMPV01HGSL

AMPV01-AHG48E; AMPV01-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMPV01HGSL
Basic UDI-DI: B-81649002AMPV01HGSL
Reference: AMPV01-AHG48E; AMPV01-AHG96E
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details