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Monkeypox virus IgG/IgM Rapid Test

Monkeypox virus IgG/IgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910063
Basic UDI-DI: B-06974238910063
Reference: HMKP053T
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Coronavirus COVID-19 IgG/IgM Antibody Rapid Test (Whole Blood/ Serum/Plasma)

Coronavirus COVID-19 IgG/IgM Antibody Rapid Test (Whole Blood/ Serum/Plasma)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910049
Basic UDI-DI: B-06974238910049
Reference: YMC049G
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Test (POCT)

SARS-CoV-2 Antigen Rapid Test (POCT)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910032
Basic UDI-DI: B-06974238910032
Reference: HCOV016GP
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Test (POCT)

SARS-CoV-2 Antigen Rapid Test (POCT)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910025
Basic UDI-DI: B-06974238910025
Reference: HCOV016GP
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibody Rapid Test

SARS-CoV-2 Neutralizing Antibody Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910018
Basic UDI-DI: B-06974238910018
Reference: HCOV018N
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibody Rapid Test

20T/K

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910001
Basic UDI-DI: B-06974238910001
Reference: HCOV018N
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

RV/AV Rapid Test Kit

A10029001E

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861684273
Basic UDI-DI: B-06973861684273
Reference: A10029001E
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:43

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Ag Rapid Test Kit

A02108002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861683580
Basic UDI-DI: B-06973861683580
Reference: A02108002
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:42

Manufacturer products Authorised representative products Authorised representative actors View details

Anbio Dengue NS1 Ag&IgG/IgM Rapid Test Kit

Dengue NS1 Ag&IgG/IgM Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861682927
Basic UDI-DI: B-06973861682927
Reference: A10084001
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861682910
Basic UDI-DI: B-06973861682910
Reference: A10005001
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgM/IgG Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861681661
Basic UDI-DI: B-06973861681661
Reference: A10004001
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Rapid Test Kit

1 test/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06973720139821
Basic UDI-DI: B-06973720139821
Reference: W-MV-01
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06973720138411
Basic UDI-DI: B-06973720138411
Reference: W-AgH-01S
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: OSMUNDA Medical Technology Service GmbH
Last updated: 06.07.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06973720138404
Basic UDI-DI: B-06973720138404
Reference: W-AgH-20S
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: OSMUNDA Medical Technology Service GmbH
Last updated: 06.07.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06973720138398
Basic UDI-DI: B-06973720138398
Reference: W-AgH-05S
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: OSMUNDA Medical Technology Service GmbH
Last updated: 06.07.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Rapid Test Kit

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06973720138367
Basic UDI-DI: B-06973720138367
Reference: W-MV-20
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06973720132075
Basic UDI-DI: B-06973720132075
Reference: W-AgH-20S
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: OSMUNDA Medical Technology Service GmbH
Last updated: 06.07.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06973720131733
Basic UDI-DI: B-06973720131733
Reference: W-AgH-05S
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: OSMUNDA Medical Technology Service GmbH
Last updated: 06.07.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06973720131726
Basic UDI-DI: B-06973720131726
Reference: W-AgH-01S
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: OSMUNDA Medical Technology Service GmbH
Last updated: 06.07.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Rapid Test Kit

50 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06973720131627
Basic UDI-DI: B-06973720131627
Reference: W-MV-50
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details