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Rapid Zika Virus IgG/IgM Combo Test Card

1N28C2

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963716927
Basic UDI-DI: B-06921963716927
Reference: 1N28C2
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Chikungunya IgG/IgM Combo Test Card

1N27C2

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963716910
Basic UDI-DI: B-06921963716910
Reference: 1N27C2
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2 Antigen Test Card

1N40C5-10 (for 20 Tests/Box)

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963712745
Basic UDI-DI: B-06921963712745
Reference: 1N40C5-10 (for 20 Tests/Box)
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2 Antigen Test Card

1N40C5-9

IVD self-testing devicesIVDDOn the marketKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963712660
Basic UDI-DI: B-06921963712660
Reference: 1N40C5-9
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2 Antigen Test Card

1N40C5-8

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963712585
Basic UDI-DI: B-06921963712585
Reference: 1N40C5-8
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2 Antigen Test Card

1N40C5-6

IVD generalIVDDOn the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963712332
Basic UDI-DI: B-06921963712332
Reference: 1N40C5-6 (20 Tests/Kit)
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2 Antigen Test Card

1N40C5-4

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963712264
Basic UDI-DI: B-06921963712264
Reference: 1N40C5-4
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2 Antigen Test Card

1N40C5-2 (1 Test/Kit)

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963712257
Basic UDI-DI: B-06921963712257
Reference: 1N40C5-2
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid 2019-nCoV IgG/IgM Combo Test Card

1N38C2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963712059
Basic UDI-DI: B-06921963712059
Reference: 1N38C2
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2 Antigen Test Card

1N40C5

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963711984
Basic UDI-DI: B-06921963711984
Reference: 1N40C5
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 Antigen Rapid Tests for Self-Testing

CG3610

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807602942
Basic UDI-DI: B-06921807602942
Reference: CG3625
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Austria
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

AzureSeq CE qPCR Kit SARS-CoV-2 for 400 Reactions

AzureSeq-400 CE

IVD generalIVDDNo longer on the marketKitProfessional testing

Manufacturer: Omixon Biocomputing Ltd.
Manufacturer SRN: HU-MF-000003018
UDI-DI: 05999565781217
Basic UDI-DI: B-05999565781217
Reference: AzureSeq-400 CE
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Hungary
Authorised representative: -
Last updated: 03.08.2026 03:24

Manufacturer products View details

AzureSeq CE qPCR Kit SARS-CoV-2 for 200 Reactions

AzureSeq-200 CE

IVD generalIVDDNo longer on the marketKitProfessional testing

Manufacturer: Omixon Biocomputing Ltd.
Manufacturer SRN: HU-MF-000003018
UDI-DI: 05999565781187
Basic UDI-DI: B-05999565781187
Reference: AzureSeq-200 CE
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Hungary
Authorised representative: -
Last updated: 03.08.2026 03:24

Manufacturer products View details

AzureSeq 4 CE qPCR Kit for 200 Reactions

AzureSeq 4-200 CE

IVD generalIVDDNo longer on the marketKitProfessional testing

Manufacturer: Omixon Biocomputing Ltd.
Manufacturer SRN: HU-MF-000003018
UDI-DI: 05999565781231
Basic UDI-DI: B-05999565781231
Reference: AzureSeq 4-200 CE
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Hungary
Authorised representative: -
Last updated: 03.08.2026 03:24

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lateral flow test

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012998
Basic UDI-DI: B-05944759012998
Reference: SN 2.4
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Romania
Authorised representative: -
Last updated: 03.08.2026 01:44

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See Now Dengue IgG/IgM antibody test