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ADV/RSV Antigen Rapid Test Device

P212106

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600118
Basic UDI-DI: B-16972698600118
Reference: P212106
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

TruDerma

Dermatophyte PCR Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245349
Basic UDI-DI: B-15065026245349
Reference: TM10002
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

mariPOC® Quick combi+ test plate

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1214MGG
Basic UDI-DI: B-1214MGG
Reference: 1214M
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:53

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mariPOC® RTI combi+ test plate

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1194MHH
Basic UDI-DI: B-1194MHH
Reference: 1194M
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:52

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mariPOC® Respi+ test plate

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1184MHC
Basic UDI-DI: B-1184MHC
Reference: 1184M
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:52

Manufacturer products View details

mariPOC® Pharyn test plate

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1124MGE
Basic UDI-DI: B-1124MGE
Reference: 1124M
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:47

Manufacturer products View details

EasyScreen

EasyScreen® SARS CoV-2 Detection Kit

IVD generalIVDDNo longer on the marketInstrumentKitReagentSingle use

Manufacturer: Genetic Signatures Ltd
Manufacturer SRN: AU-MF-000030901
UDI-DI: 09351179002090
Basic UDI-DI: B-09351179002090
Reference: RP012-HT
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Ireland
Authorised representative: mdi Europa GmbH
Last updated: 10.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

EasyScreen

EasyScreen Respiratory Pathogen Detection Kit (RP007)

IVD generalIVDDNo longer on the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: Genetic Signatures Ltd
Manufacturer SRN: AU-MF-000030901
UDI-DI: 09351179002021
Basic UDI-DI: B-09351179002021
Reference: RP007-HT
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 10.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

EasyScreen

EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001)