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Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)

S3357E-1

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 16955792730684
Basic UDI-DI: B-16955792730684
Reference: S3357E-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:12

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)

S3355E-50

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 16955792730677
Basic UDI-DI: B-16955792730677
Reference: S3355E-50
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:12

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)

S3355E-25

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 16955792730660
Basic UDI-DI: B-16955792730660
Reference: S3355E-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:12

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)

S3355E-5

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 16955792730653
Basic UDI-DI: B-16955792730653
Reference: S3355E-5
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:12

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)

S3355E-1

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 16955792730646
Basic UDI-DI: B-16955792730646
Reference: S3355E-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:12

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Typhoid Ag Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763211
Basic UDI-DI: B-15065023763211
Reference: TV10022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
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

TruVue

Typhoid Ab Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763204
Basic UDI-DI: B-15065023763204
Reference: TV10021
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
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

TruVue

Dengue IgG/IgM/ NS1 Combo Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763198
Basic UDI-DI: B-15065023763198
Reference: TV10020
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Dengue NS1 Ag Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763181
Basic UDI-DI: B-15065023763181
Reference: TV10019
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Dengue IgG/IgM Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763174
Basic UDI-DI: B-15065023763174
Reference: TV10018
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Respiratory Syncytial Virus (RSV) Antigen Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763068
Basic UDI-DI: B-15065023763068
Reference: TV10007
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Influenza A+B Antigen Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763044
Basic UDI-DI: B-15065023763044
Reference: TV10005
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

mariPOC® SARS-CoV-2 test plate

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1204SGP
Basic UDI-DI: B-1204SGP
Reference: 1204S
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:53

Manufacturer products View details

ReaScan+ PUUMALA IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: D-115105LZ
Basic UDI-DI: B-115105LZ
Reference: 115105
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:51

Manufacturer products View details

ReaScan TBE IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: D-114106LU
Basic UDI-DI: B-114106LU
Reference: 114106
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:48

Manufacturer products View details

ReaScan DOBRAVA-HANTAAN IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: D-114102LL
Basic UDI-DI: B-114102LL
Reference: 114102
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:48

Manufacturer products View details

Reagena POC PUUMALA IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: D-114001LD
Basic UDI-DI: B-114001LD
Reference: 114001
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:48

Manufacturer products View details

Greencare Flu 2 Influenza A&B Ag

IVD generalIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134616016
Basic UDI-DI: B-08806134616016
Reference: 161G
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIA Multi Influenza Ag Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134615217
Basic UDI-DI: B-08806134615217
Reference: 152GS10
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

08800069130081

InstaView COVID-19/Flu Ag Combo

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SG BioScience Inc.
Manufacturer SRN: KR-MF-000009362
UDI-DI: 08800069130081
Basic UDI-DI: B-08800069130081
Reference: R3008
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 05:13

Manufacturer products Authorised representative products Authorised representative actors View details