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Enterovirus 71 IgM Antibody Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620711
Basic UDI-DI: B-06974854620711
Reference: P2202120
EMDN: W0105040602
EMDN description: ENTEROVIRUS
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 Ag Combo Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620629
Basic UDI-DI: B-06974854620629
Reference: P2201320
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
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

Dengue Ag+IgG/IgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620612
Basic UDI-DI: B-06974854620612
Reference: P2201225
EMDN: W0105040611
EMDN description: DENGUE VIRUS
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

Rotavirus, Adenovirus Antigen Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620575
Basic UDI-DI: B-06974854620575
Reference: P2200925
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
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)

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

Enzyme-Linked Immunosorbent Assay for detecting SARS-CoV-2 Neutralization Antibody

96 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366181
Basic UDI-DI: B-06974849366181
Reference: HWTS-RT070A
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

Enzyme-Linked Immunosorbent Assay for detecting SARS-CoV-2 Spike RBD Antibody

96 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366143
Basic UDI-DI: B-06974849366143
Reference: HWTS-RT055A
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Virus Antigen Detection Kit (Immunofluorescence Chromatography)

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366136
Basic UDI-DI: B-06974849366136
Reference: HWTS-RT054A
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

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

Influenza A&B Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750396
Basic UDI-DI: B-06974785750396
Reference: IIN-1023
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
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

Rotavirus Rapid Test (Feces)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750372
Basic UDI-DI: B-06974785750372
Reference: IRO-3013
EMDN: W0105040606
EMDN description: ROTAVIRUS
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

Adenovirus Rapid Test (Feces)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750365
Basic UDI-DI: B-06974785750365
Reference: IAD-3013
EMDN: W0105040601
EMDN description: ADENOVIRUS
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

NORO (Norovirus) Rapid Test (Feces)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750358
Basic UDI-DI: B-06974785750358
Reference: INO-3013
EMDN: W0105040616
EMDN description: NOROVIRUS
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

KEYU Norovirus Antigen Test Kit (Colloidal gold method)

NV-II

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361863
Basic UDI-DI: B-06974735361863
Reference: NV-II
EMDN: W0105040616
EMDN description: NOROVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Norovirus Antigen Test Kit (Colloidal gold method)

NV-I

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361856
Basic UDI-DI: B-06974735361856
Reference: NV-I
EMDN: W0105040616
EMDN description: NOROVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Rotavirus/Adenovirus Antigen Rapid Test (Colloidal Gold)

RV/ADV-R-G

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360927
Basic UDI-DI: B-06974735360927
Reference: RV/ADV-R-G
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details