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Inﬂuenza A+B Antigen Rapid Test Device

1Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303209
Basic UDI-DI: B-06974566303209
Reference: RIN-8221
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Inﬂuenza B Antigen Rapid Test

1Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303193
Basic UDI-DI: B-06974566303193
Reference: RINb-8021
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Inﬂuenza B Antigen Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303186
Basic UDI-DI: B-06974566303186
Reference: RINb-80225
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Estonia
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Inﬂuenza B Antigen Rapid Test

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303179
Basic UDI-DI: B-06974566303179
Reference: RINb-8025
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Group A Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566302967
Basic UDI-DI: B-06974566302967
Reference: W0105040606
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566302943
Basic UDI-DI: B-06974566302943
Reference: RSV-402
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 & Inﬂuenza A/B Antigen Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566302912
Basic UDI-DI: B-06974566302912
Reference: MRP-82220
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG/IgM Rapid Test

1Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566302769
Basic UDI-DI: B-06974566302769
Reference: IZK-4221
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG/IgM Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566302752
Basic UDI-DI: B-06974566302752
Reference: IZK-42225
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 Antigen Rapid Test Device

5Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566301359
Basic UDI-DI: B-06974566301359
Reference: MSA-8025
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 Antigen Rapid Test Device

1Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566301342
Basic UDI-DI: B-06974566301342
Reference: MSA-8021
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 Antigen Rapid Test Device

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566301335
Basic UDI-DI: B-06974566301335
Reference: MSA-80220
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Bulgaria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus (MPxV) Antigen Rapid Detection Kit (Colloidal Gold)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521008071
Basic UDI-DI: B-06974521008071
Reference: SUPG290025
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001874
Basic UDI-DI: B-06974521001874
Reference: SUPG021025-1
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001867
Basic UDI-DI: B-06974521001867
Reference: SUPG021025
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for 2019-Novel Coronavirus(2019-nCoV) Ag Test (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000464
Basic UDI-DI: B-06974521000464
Reference: SUPF044025
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Test Cassette

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Merlin Biomedical (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000021840
UDI-DI: 06974487560187
Basic UDI-DI: B-06974487560187
Reference: CP0271-1
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:18

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) Saliva Test

RQ013

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473308847
Basic UDI-DI: B-06974473308847
Reference: RQ013
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Virus Neutralization Test Kit (Colloidal gold method)

RQ006

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473308427
Basic UDI-DI: B-06974473308427
Reference: RQ006
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit(Colloidal gold method)

RQ005

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473308380
Basic UDI-DI: B-06974473308380
Reference: RQ005
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details