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597 device results listed.

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Malaria Ag P.f/Pan Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620667
Basic UDI-DI: B-06974854620667
Reference: P2201625
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
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

Malaria Pf/Pv Ag Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620643
Basic UDI-DI: B-06974854620643
Reference: P2201425
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
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

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

06974671100373

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100373
Basic UDI-DI: B-06974671100373
Reference: DR-PA-A001
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

06974671100366

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100366
Basic UDI-DI: B-06974671100366
Reference: DR-PA-A002
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

Chagas Ab Combo Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303599
Basic UDI-DI: B-06974566303599
Reference: ICS-402
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania Ab Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303155
Basic UDI-DI: B-06974566303155
Reference: ILE-402
EMDN: W0105050205
EMDN description: LEISHMANIA
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 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

Manufacturer products Authorised representative products Authorised representative actors View details

Giardia Lamblia Rapid Test Kit (Colloidal gold method)

CR034

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473309424
Basic UDI-DI: B-06974473309424
Reference: CR034
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
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/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

Trichomonas Vaginalis Antigen Rapid Test Kit (Colloidal gold method)

CR026

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473301718
Basic UDI-DI: B-06974473301718
Reference: CR026
EMDN: W0105050210
EMDN description: TRICHOMONAS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

06974323013754

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

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323013754
Basic UDI-DI: B-06974323013754
Reference: IH012
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

06974323013747

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

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323013747
Basic UDI-DI: B-06974323013747
Reference: IH012
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

06974323013730

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

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323013730
Basic UDI-DI: B-06974323013730
Reference: IH012
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

06974323011163

Real-Time PCR Detection Kit for Universal Plasmodium Falciparum

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011163
Basic UDI-DI: B-06974323011163
Reference: A3751
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

06974323011156

Real-Time PCR Detection Kit for Universal Plasmodium Falciparum

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011156
Basic UDI-DI: B-06974323011156
Reference: A3751
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

06974323011040

Real-time PCR Detection Kit for Plasmodium Vivax

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011040
Basic UDI-DI: B-06974323011040
Reference: ID048
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details