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81 device results listed.

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Malaria Antibody Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349CR046GT
Basic UDI-DI: B-CNMF000054349CR046GT
Reference: CR046
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:08

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349CR002G7
Basic UDI-DI: B-CNMF000054349CR002G7
Reference: CR002
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat® Malaria Pv/Pf

601010025

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139019
Basic UDI-DI: B-08908020139019
Reference: 601010025
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat Malaria Pv/Pf

601010050

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989330
Basic UDI-DI: B-08908007989330
Reference: 601010050
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat Malaria Pv/Pf

601010020

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989323
Basic UDI-DI: B-08908007989323
Reference: 601010020
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat® Malaria Pv/Pf

601010005

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989316
Basic UDI-DI: B-08908007989316
Reference: 601010005, 601010020,601010025, 601010050
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

08800204300638

RADI Malaria Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300638
Basic UDI-DI: B-08800204300638
Reference: RB007
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 08:15

Manufacturer products Authorised representative products Authorised representative actors View details

08800204300584

CHAMP Malaria P.f Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300584
Basic UDI-DI: B-08800204300584
Reference: CB001
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx Malaria qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213967
Basic UDI-DI: B-08684387213967
Reference: IP202455-100
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:00

Manufacturer products View details

RevoDx Malaria qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213950
Basic UDI-DI: B-08684387213950
Reference: IP202455-25
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:00

Manufacturer products View details

LyoSens Malaria Detection qPCR Kit

LYO69

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259875
Basic UDI-DI: B-08683548259875
Reference: LYO69
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:21

Manufacturer products View details

Malaria Pf/Pan Antigen Rapid Test Cassette(Colloidal Gold)

1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698401744
Basic UDI-DI: B-06977698401744
Reference: GKPD034
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf Antigen Rapid Test Cassette(Colloidal Gold)

1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698401683
Basic UDI-DI: B-06977698401683
Reference: GKPD033
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Ag P.f (HRP-Ⅱ) Assay Reagent Kit (CMIA)

C2KC003