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86 device results listed.

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K404-Plasmodium vivax

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430645
Basic UDI-DI: B-04262420430645
Reference: K404
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

Manufacturer products View details

K201-Plasmodium falciparum

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430614
Basic UDI-DI: B-04262420430614
Reference: K201
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

Manufacturer products View details

miLab™ Cartridge MAL

CMAA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Noul Co., Ltd.
Manufacturer SRN: KR-MF-000033621
UDI-DI: 18800100110017
Basic UDI-DI: B-18800100110017
Reference: CMAA
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 19:16

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmodium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792734234
Basic UDI-DI: B-06955792734234
Reference: S3187E-24
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmodium DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733336
Basic UDI-DI: B-06955792733336
Reference: S3093E
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Loopamp™ Malaria Pf Detection Kit

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04033145206699
Basic UDI-DI: 4987026TD-LFMFYZ
Reference: 978000
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Human Gesellschaft für Biochemica und Diagnostica mbH
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

Loopamp™ Malaria Pv Detection Kit

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04033145206682
Basic UDI-DI: 4987026TD-LFMV24
Reference: 975000
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Human Gesellschaft für Biochemica und Diagnostica mbH
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

Loopamp™ Malaria Pan Detection Kit

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04033145191407
Basic UDI-DI: 4987026TD-LFMPZM
Reference: 974000
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Human Gesellschaft für Biochemica und Diagnostica mbH
Last updated: 31.07.2026 07:30

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f. Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMA-401PC
Basic UDI-DI: B-IMA-401PC
Reference: IMA-401
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./P.v. Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMPV-402Q2
Basic UDI-DI: B-IMPV-402Q2
Reference: IMPV-402
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./Pan Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMPN-402MA
Basic UDI-DI: B-IMPN-402MA
Reference: IMPN-402
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f. Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMA-402PE
Basic UDI-DI: B-IMA-402PE
Reference: IMA-402
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./P.v. /Pan Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-MAL-435QF
Basic UDI-DI: B-FI-MAL-435QF
Reference: FI-MAL-435
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Loopamp™ Malaria Pan Detection Kit

IVD Class CNot specifiedOn the marketProfessional testingReagent

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04033145206705
Basic UDI-DI: 4987026TD-LFMPZM
Reference: 977000
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: -
Authorised representative: Human Gesellschaft für Biochemica und Diagnostica mbH
Last updated: 18.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

+ENTIRE589010H

Malaria

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE589010H
Basic UDI-DI: B-+ENTIRE589010H
Reference: RE58901
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIMAL0620DS0C

NovaLisa® Malaria

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIMAL0620DS0C
Basic UDI-DI: B-+ENTIMAL0620DS0C
Reference: MAL0620DS
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTIMAL06200E

NovaLisa® Malaria

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIMAL06200E
Basic UDI-DI: B-+ENTIMAL06200E
Reference: MAL0620
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTIEIA-551100

Malaria ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-551100
Basic UDI-DI: B-+ENTIEIA-551100
Reference: EIA-5511
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

Plasmodium Genotyping Real Time PCR Ki

YJW20601NW-50T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-YJW20601NW-50TQL
Basic UDI-DI: B-YJW20601NW-50TQL
Reference: YJW20601NW-50T
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmodium Genotyping Real Time PCR K

YJW20601NW-25T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-YJW20601NW-25TQL
Basic UDI-DI: B-YJW20601NW-25TQL
Reference: YJW20601NW-25T
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details