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81 device results listed.

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Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Plasmodium

50 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: 06974849366037
Basic UDI-DI: B-06974849366037
Reference: HWTS-OT033A
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria pf Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303131
Basic UDI-DI: B-06974566303131
Reference: IMA-402
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf/Pan Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303124
Basic UDI-DI: B-06974566303124
Reference: IMA-422
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria pf/pv Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303117
Basic UDI-DI: B-06974566303117
Reference: IMA-432
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:54

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Malaria pf/pan Rapid Test Kit (Colloidal gold method)

CR018

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473309288
Basic UDI-DI: B-06974473309288
Reference: CR018
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
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

Malaria pf/pv Antigen Rapid Test Kit (Colloidal gold method)

CR002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473304627
Basic UDI-DI: B-06974473304627
Reference: CR002
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:11

Manufacturer products Authorised representative products Authorised representative actors View details

06974323013754

Plasmodium Falciparum/Plasmodium Vivax Antigen Rapid Test Cassette (Colloidal Gold Method)