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Zika IgG/IgM Rapid Test Cassette

Zika IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IZIB-R402F5
Basic UDI-DI: B-IZIB-R402F5
Reference: IZIB-R402
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:07

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Rapid Test Cassette

RSV Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRS-R502N7
Basic UDI-DI: B-IRS-R502N7
Reference: IRS-R502
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Rapid Test Cassette

Rotavirus Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRO-R602LQ
Basic UDI-DI: B-IRO-R602LQ
Reference: IRO-R602
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

Rhinovirus Rapid Test

Rhinovirus Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRHV-R502J5
Basic UDI-DI: B-IRHV-R502J5
Reference: IRHV-R502
EMDN: W0105040620
EMDN description: RHINOVIRUS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

HPIV Rapid Test

HPIV Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IPIV-R502HG
Basic UDI-DI: B-IPIV-R502HG
Reference: IPIV-R502
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-COV-S8293

5 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-COV-S8293
Basic UDI-DI: B-CNMF000014455-COV-S8293
Reference: COV-S82
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-COV-S418M

96 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-COV-S418M
Basic UDI-DI: B-CNMF000014455-COV-S418M
Reference: COV-S41
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-COV-S728Y

25 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-COV-S728Y
Basic UDI-DI: B-CNMF000014455-COV-S728Y
Reference: COV-S72
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-COV-S818Z

1 Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-COV-S818Z
Basic UDI-DI: B-CNMF000014455-COV-S818Z
Reference: COV-S81
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-COV-S718W

COV-S71

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-COV-S718W
Basic UDI-DI: B-CNMF000014455-COV-S718W
Reference: COV-S71
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-COV-S618T

5 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-COV-S618T
Basic UDI-DI: B-CNMF000014455-COV-S618T
Reference: COV-S61
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-COV-S528S

25 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-COV-S528S
Basic UDI-DI: B-CNMF000014455-COV-S528S
Reference: COV-S52
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-COV-S518Q

10 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-COV-S518Q
Basic UDI-DI: B-CNMF000014455-COV-S518Q
Reference: COV-S51
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-COV-S318J

1 Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-COV-S318J
Basic UDI-DI: B-CNMF000014455-COV-S318J
Reference: COV-S31
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:55

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Hand Foot And Mouth Disease Rapid Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A045D5
Basic UDI-DI: B-A045D5
Reference: INDICAID™ Hand Foot And Mouth Disease Rapid Antibody Test
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Rapid Test（Swab）

RSV Antigen Rapid Test（Swab）

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840313222
Basic UDI-DI: B-69743840313222
Reference: 3022001
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Zika Rapid Test

Zika Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840311242
Basic UDI-DI: B-69743840311242
Reference: 3023903
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

Parvovirus antigen（CPV Ag/FPV Ag） Rapid Test

Parvovirus antigen（CPV Ag/FPV Ag） Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840310870
Basic UDI-DI: B-69743840310870
Reference: 3027601
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Antigen & IgG/IgM Rapid Test（Whole Blood/Serum/Plasma）

Dengue NS1 Antigen & IgG/IgM Rapid Test（Whole Blood/Serum/Plasma）

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840309430
Basic UDI-DI: B-69743840309430
Reference: 3021303
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus Antigen Rapid Test

Norovirus Antigen Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840309058
Basic UDI-DI: B-69743840309058
Reference: 3022101
EMDN: W0105040616
EMDN description: NOROVIRUS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details