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06928103001516

Single tube, 20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103001516
Basic UDI-DI: B-06928103001516
Reference: DA0151
EMDN: W0105040403
EMDN description: EBV - NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06928103001509

Single tube, 20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103001509
Basic UDI-DI: B-06928103001509
Reference: DA0150
EMDN: W0105040403
EMDN description: EBV - NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Flu A&B Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570022
Basic UDI-DI: B-04719878570022
Reference: PCRAE0103
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR SARS-CoV-2 Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570169
Basic UDI-DI: B-04719878570169
Reference: PCRAE0114
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR SARS-CoV-2 Gen 2 Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570220
Basic UDI-DI: B-04719878570220
Reference: PCRAE0120
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaSIRO solo HPV Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570541
Basic UDI-DI: B-04719878570541
Reference: PCRAD1104/ PCRAD1114
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

1×100 test/kit R1:1×4mL R2:1×5mL R3:1×9mL Calibrator High value:1×1mL; L Calibrator Low value:1×1mL Control Level 1: 1×1mL; Control Level 2: 1×1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794574459
Basic UDI-DI: B-06925794574459
Reference: 1×100 test/kit R1:1×4mL R2:1×5mL R3:1×9mL Calibrator High value:1×1mL; L Calibrator Low value:1×1mL etc
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

1×100 test/kit R1:1×2mL; R2:1×2.5mL; R3:1×2.5mL Calibrator High value:1×1mL; Calibrator Low value:1×1mL Control Level 1:1×1mL Control Level 2: 1×1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794574442
Basic UDI-DI: B-06925794574442
Reference: 1×100 test/kit etc
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:38

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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

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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

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