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mariPOC® Parainfluenza virus 3 test reagent

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

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

mariPOC® Parainfluenza virus 1 test reagent

mariPOC® Parainfluenza virus 1 test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R08ET
Basic UDI-DI: B-1R08ET
Reference: 1R08
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:18

Manufacturer products View details

mariPOC® Influenza B virus test reagent

mariPOC® Influenza B virus test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R07ER
Basic UDI-DI: B-1R07ER
Reference: 1R07
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:18

Manufacturer products View details

mariPOC® Influenza A virus test reagent

mariPOC® Influenza A virus test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R06EP
Basic UDI-DI: B-1R06EP
Reference: 1R06
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:17

Manufacturer products View details

mariPOC® Human metapneumovirus test reagent

mariPOC® Human metapneumovirus test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R05EM
Basic UDI-DI: B-1R05EM
Reference: 1R05
EMDN: W0105040617
EMDN description: HUMAN METAPNEUMOVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:17

Manufacturer products View details

mariPOC® Human coronavirus OC43 test reagent

mariPOC® Human coronavirus OC43 test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R04EK
Basic UDI-DI: B-1R04EK
Reference: 1R04
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:17

Manufacturer products View details

mariPOC® Human bocavirus test reagent

mariPOC® Human bocavirus test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R03EH
Basic UDI-DI: B-1R03EH
Reference: 1R03
EMDN: W0105040618
EMDN description: BOCAVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:17

Manufacturer products View details

mariPOC® Adenovirus respiratory test reagent

mariPOC® Adenovirus respiratory test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R01ED
Basic UDI-DI: B-1R01ED
Reference: 1R01
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:17

Manufacturer products View details

MONO-VIDITEST anti-TBEV IgG avidity

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: 18594036043135
Basic UDI-DI: B-18594036043135
Reference: K-313-12
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 10:25

Manufacturer products View details

MONO-VIDITEST anti-TBEV IgM

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: 18594036043111
Basic UDI-DI: B-18594036043111
Reference: K-311-12
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 10:25

Manufacturer products View details

MONO-VIDITEST anti-TBEV IgG

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: 18594036043104
Basic UDI-DI: B-18594036043104
Reference: K-310-12
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 10:25

Manufacturer products View details

SARS-Cov-2 Antigen Rapid Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Hangzhou Higene Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000029811
UDI-DI: 16974198355017
Basic UDI-DI: B-16974198355017
Reference: nCoVAG
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-Cov-2 Antigen FLU A+B Antigen combo Rapid Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Hangzhou Higene Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000029811
UDI-DI: 16974198354010
Basic UDI-DI: B-16974198354010
Reference: nCoFLu
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-Cov-2(covid-19)IgMIgG Antibody Fast Detection Kit（Colloidal Gold）

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Hangzhou Higene Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000029811
UDI-DI: 16974198352016
Basic UDI-DI: B-16974198352016
Reference: NCoV
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR Kit for Rapid Detection of SARS-COV-2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hangzhou Higene Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000029811
UDI-DI: 16974198351019
Basic UDI-DI: B-16974198351019
Reference: nCoV
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Antigen Rapid Test

Strep A Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601351
Basic UDI-DI: B-16972698601351
Reference: P211116
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/FluA/FluB Antigen Detection Kit(Colloidal Gold)

Model A：25test/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000026852
UDI-DI: 16972235840038
Basic UDI-DI: B-16972235840038
Reference: LCV07
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763143
Basic UDI-DI: B-15065023763143
Reference: TV10015
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

ADV Antigen Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763075
Basic UDI-DI: B-15065023763075
Reference: TV10008
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details