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258 device results listed.

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Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00305

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600206
Basic UDI-DI: B-06975146600206
Reference: MPX00305
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00301

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600190
Basic UDI-DI: B-06975146600190
Reference: MPX00205
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00220

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600183
Basic UDI-DI: B-06975146600183
Reference: MPX00205
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

06975146600176

MPX00205

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600176
Basic UDI-DI: B-06975146600176
Reference: MPX00205
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

06975146600169

MPX00201

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600169
Basic UDI-DI: B-06975146600169
Reference: MPX00101
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00120

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600152
Basic UDI-DI: B-06975146600152
Reference: MPX00120
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00105

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600145
Basic UDI-DI: B-06975146600145
Reference: MPX00101
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00101

IVD generalIVDDOn the marketReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600138
Basic UDI-DI: B-06975146600138
Reference: MPX00101
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Nipah Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858561379
Basic UDI-DI: B-06974858561379
Reference: P6087H
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox virus Antigen Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620834
Basic UDI-DI: B-06974854620834
Reference: P2211525
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

JWF

Orthopox virus and Monkeypox virus Antigen Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620827
Basic UDI-DI: B-06974854620827
Reference: P2203525
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A/B & COVID-19 Ag Combo Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620803
Basic UDI-DI: B-06974854620803
Reference: P2203120
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368611
Basic UDI-DI: B-06974849368611
Reference: HWTS-OT147C
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368604
Basic UDI-DI: B-06974849368604
Reference: HWTS-OT145B
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)

1 test/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368598
Basic UDI-DI: B-06974849368598
Reference: HWTS-OT145A
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Detection Kit (Immunochromatography)

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368581
Basic UDI-DI: B-06974849368581
Reference: HWTS-OT079G
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Detection Kit (Immunochromatography)

1 test/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368567
Basic UDI-DI: B-06974849368567
Reference: HWTS-OT079E
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus Combo Rapid Test Cassette (Feces)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750471
Basic UDI-DI: B-06974785750471
Reference: IRA-3023
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:43

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Rapid Test(Lateral Flow Method)

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674894026
Basic UDI-DI: B-06974674894026
Reference: 18-02-0101
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)

5 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674894002
Basic UDI-DI: B-06974674894002
Reference: 18-02-0038
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: NIC GmbH
Last updated: 06.07.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details