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Flu & COVID-19 Antigen Duo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698604277
Basic UDI-DI: B-16972698604277
Reference: P211146
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

Astrovirus Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603676
Basic UDI-DI: B-16972698603676
Reference: P221112
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

EBNA IgG Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601320
Basic UDI-DI: B-16972698601320
Reference: P231117
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

EBV-VCA IgG Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601313
Basic UDI-DI: B-16972698601313
Reference: P231116
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Enterovirus 71 IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601306
Basic UDI-DI: B-16972698601306
Reference: P231115
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

HSV 1/2 IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601290
Basic UDI-DI: B-16972698601290
Reference: P231114
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

KaiBiLi COVID-19 Antigen Pro

P211138-5

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601191
Basic UDI-DI: B-16972698601191
Reference: P211138-5
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

ANTICHEK SARS-CoV-2 (COVID-19) Antigen Test

P211135

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601184
Basic UDI-DI: B-16972698601184
Reference: P211135
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Antigen Rapid Test Device

P221102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601078
Basic UDI-DI: B-16972698601078
Reference: P221102
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Human metapneumovirus Antigen Rapid Test

P213115

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601030
Basic UDI-DI: B-16972698601030
Reference: P213115
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Neutralization Ab+ Rapid Test

P231145

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600927
Basic UDI-DI: B-16972698600927
Reference: P231145
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

EZER COVID-19 Antigen Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600866
Basic UDI-DI: B-16972698600866
Reference: P213108
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

EZER COVID-19 Antigen Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600798
Basic UDI-DI: B-16972698600798
Reference: P213105
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

KaiBiLi COVID-19 Antigen Saliva Test

P211142

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600774
Basic UDI-DI: B-16972698600774
Reference: P211142
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

KaiBiLi COVID-19 Antigen Saliva Test

P211141

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600767
Basic UDI-DI: B-16972698600767
Reference: P211141
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

HPIVs Antigen Rapid Test

P213114

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600736
Basic UDI-DI: B-16972698600736
Reference: P213114
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Neutralization Antibody Rapid Test

P231141

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600675
Basic UDI-DI: B-16972698600675
Reference: P231141
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Total Antibody Rapid Test

P231140

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600668
Basic UDI-DI: B-16972698600668
Reference: P231140
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

KaiBiLi COVID-19 Antigen

P211139

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600590
Basic UDI-DI: B-16972698600590
Reference: P211139
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

KaiBiLi COVID-19 Antigen Pro

P211138

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600583
Basic UDI-DI: B-16972698600583
Reference: P211138
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details