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197 device results listed.

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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-R402FZ
Basic UDI-DI: B-IMPN-R402FZ
Reference: IMPN-R402
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:39

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-R402C3
Basic UDI-DI: B-IMA-R402C3
Reference: Alltest
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Croatia
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmodium falciparum and Plasmodium vivax Antigen Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD160XG
Basic UDI-DI: B-GKPD160XG
Reference: GKPD160
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmodium falciparum and Pan-plasmodium Antigen Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD159XX
Basic UDI-DI: B-GKPD159XX
Reference: GKPD159
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f/P.v Ag Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD114X9
Basic UDI-DI: B-GKPD114X9
Reference: GKPD114
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma)

GCMAL(pf/pv Ab)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMAL(pf/pvAb)-402aHG7N
Basic UDI-DI: B-GCMAL(pf/pvAb)-402aHG7N
Reference: GCMAL(pf/pv Ab)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma)

GCMAL(pf/pv Ab)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMAL(pf/pvAb)-402aAB
Basic UDI-DI: B-GCMAL(pf/pvAb)-402aAB
Reference: GCMAL(pf/pv Ab)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma)

GCMAL(pf/pv Ab)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMAL(pf/pvAb)-302aHG79
Basic UDI-DI: B-GCMAL(pf/pvAb)-302aHG79
Reference: GCMAL(pf/pv Ab)-302a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma)

GCMAL(pf/pv Ab)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMAL(pf/pvAb)-302aA4
Basic UDI-DI: B-GCMAL(pf/pvAb)-302aA4
Reference: GCMAL(pf/pv Ab)-302a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood)

GCMAL(pf/pv)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMAL(pf/pv)-402aTT
Basic UDI-DI: B-GCMAL(pf/pv)-402aTT
Reference: GCMAL(pf/pv)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood)

GCMAL(pf/pv)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMAL(pf/pv)-402aHGG2
Basic UDI-DI: B-GCMAL(pf/pv)-402aHGG2
Reference: GCMAL(pf/pv)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood)

GCMAL(pf/pan)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMAL(pf/pan)-402aHGAD
Basic UDI-DI: B-GCMAL(pf/pan)-402aHGAD
Reference: GCMAL(pf/pan)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood)

GCMAL(pf/pan)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMAL(pf/pan)-402aBS
Basic UDI-DI: B-GCMAL(pf/pan)-402aBS
Reference: GCMAL(pf/pan)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f. Ag Rapid Test Casssette (Whole Blood)

GCMAL(pf)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMAL(pf)-402a83
Basic UDI-DI: B-GCMAL(pf)-402a83
Reference: GCMAL(pf)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pan Ag Rapid Test Cassette (Whole Blood)

GCMAL(pan)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMAL(pan)-402aHG2H
Basic UDI-DI: B-GCMAL(pan)-402aHG2H
Reference: GCMAL(pan)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pan Ag Rapid Test Cassette (Whole Blood)

GCMAL(pan)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMAL(pan)-402aAX
Basic UDI-DI: B-GCMAL(pan)-402aAX
Reference: GCMAL(pan)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf Ag Rapid Test Cassette (Whole Blood)

GCMAL(Pf)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMAL(Pf)-402aHGKG
Basic UDI-DI: B-GCMAL(Pf)-402aHGKG
Reference: GCMAL(Pf)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria-Q Real-Time PCR Kit

G2M706221

IVD generalIVDDOn the marketKitNear-patient testingProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M706221FF
Basic UDI-DI: B-G2M706221FF
Reference: G2M706221, G2M706221R
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell®Malaria P.f./Pan Cassette(Whole Blood)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-B99VL
Basic UDI-DI: B-ABT-IDT-B99VL
Reference: ABT-IDT-B99
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Malaria P.f. Cassette(Whole Blood)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-B85V9
Basic UDI-DI: B-ABT-IDT-B85V9
Reference: ABT-IDT-B85
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details