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Astrovirus

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313276394
Basic UDI-DI: B-86060313276394
Reference: C1814AST
EMDN: W0105040629
EMDN description: ASTROVIRUS
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313275540
Basic UDI-DI: B-86060313275540
Reference: C1808V24NORV
EMDN: W0105040616
EMDN description: NOROVIRUS
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313275472
Basic UDI-DI: B-86060313275472
Reference: C1809V24ROTV
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002APA01E37Y

APA01-AHG48E; APA01-AHG96E; APA01D-AHG48E; APA01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002APA01E37Y
Basic UDI-DI: B-81649002APA01E37Y
Reference: APA01-AHG48E; APA01-AHG96E; APA01D-AHG48E; APA01D-AHG96E
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
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

MONO-VIDITEST anti-TBEV IgG avidity

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036043139
Basic UDI-DI: B-38594036043139
Reference: KZ-313-12
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

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MONO-VIDITEST anti-TBEV IgM

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036043115
Basic UDI-DI: B-38594036043115
Reference: KZ-311-12
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

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MONO-VIDITEST anti-TBEV IgG

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036043108
Basic UDI-DI: B-38594036043108
Reference: KZ-310-12
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

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mariPOC® Rotavirus test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-2R07EY
Basic UDI-DI: B-2R07EY
Reference: 2R07
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 16:58

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mariPOC® Norovirus GII.4 test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-2R06EW
Basic UDI-DI: B-2R06EW
Reference: 2R06
EMDN: W0105040616
EMDN description: NOROVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 16:58

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mariPOC® Norovirus GI test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-2R05EU
Basic UDI-DI: B-2R05EU
Reference: 2R05
EMDN: W0105040616
EMDN description: NOROVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 16:58

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mariPOC® Adenovirus gastrointestinal test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-2R01EL
Basic UDI-DI: B-2R01EL
Reference: 2R01
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 16:58

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ELISA-VIDITEST anti-JCV IgG

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036044504
Basic UDI-DI: B-28594036044504
Reference: ODZ-450
EMDN: W0105040623
EMDN description: JC VIRUS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:21

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ELISA-VIDITEST anti-BKV IgG

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036044054
Basic UDI-DI: B-28594036044054
Reference: ODZ-405
EMDN: W0105040622
EMDN description: BK VIRUS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:21

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ELISA-VIDITEST anti-TBEV IgM

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036041947
Basic UDI-DI: B-28594036041947
Reference: ODZ-194
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:21

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ELISA-VIDITEST anti-TBEV IgG (CSF)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036041923
Basic UDI-DI: B-28594036041923
Reference: ODZ-192
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:21

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ELISA-VIDITEST anti-TBEV IgG and IgG avidity

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036041701
Basic UDI-DI: B-28594036041701
Reference: ODZ-170
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:21

Manufacturer products View details

mariPOC® SARS-CoV-2 test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R13EL
Basic UDI-DI: B-1R13EL
Reference: 1R13
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:26

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mariPOC® Respiratory syncytial virus test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R12EJ
Basic UDI-DI: B-1R12EJ
Reference: 1R12
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:26

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mariPOC® Parainfluenza virus 3 test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R10EE
Basic UDI-DI: B-1R10EE
Reference: 1R10
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:26

Manufacturer products View details

mariPOC® Parainfluenza virus 2 test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R09EV
Basic UDI-DI: B-1R09EV
Reference: 1R09
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:26

Manufacturer products View details