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81 device results listed.

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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

Plasmodium DNA Real Time PCR Kit

JW20102NW-50T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JW20102NW-50TE5
Basic UDI-DI: B-JW20102NW-50TE5
Reference: JW20102NW-50T
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:35

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmodium DNA Real Time PCR Kit

JW20102NW-25T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JW20102NW-25TE5
Basic UDI-DI: B-JW20102NW-25TE5
Reference: JW20102NW-25T
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:35

Manufacturer products Authorised representative products Authorised representative actors View details

RapiMal Rapid Antigen Test kit for Malaria

G2MR172517

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2MR172517JT
Basic UDI-DI: B-G2MR172517JT
Reference: G2MR172517, G2MR170117
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria 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-CNMF000054349CR051GL
Basic UDI-DI: B-CNMF000054349CR051GL
Reference: CR051
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/pan 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-CNMF000054349CR057GY
Basic UDI-DI: B-CNMF000054349CR057GY
Reference: CR057
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