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197 device results listed.

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

Strip

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A99VF
Basic UDI-DI: B-ABT-IDT-A99VF
Reference: ABT-IDT-A99
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

NADAL® Malaria Pf/Pan Ag 4 Species Test

NADAL Malaria Pf/Pan Ag 4 Species Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-472038N-25AT
Basic UDI-DI: B-472038N-25AT
Reference: 472038N-25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:57

Manufacturer products View details

Malaria Pf/Pv Antigen Rapid Test Device

P231108

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600903
Basic UDI-DI: B-16972698600903
Reference: P231108
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf Antigen Rapid Test Device

P231107

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600897
Basic UDI-DI: B-16972698600897
Reference: P231107
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf/Pan Antigen Rapid Test Device

P231109

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600910
Basic UDI-DI: B-16972698600910
Reference: P231109
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Malaria Pf Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763112
Basic UDI-DI: B-15065023763112
Reference: TV10012
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Malaria Pf /Pv Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763105
Basic UDI-DI: B-15065023763105
Reference: TV10011
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Romania
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Malaria Pf /Pan Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763099
Basic UDI-DI: B-15065023763099
Reference: TV10010
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

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

Malaria P.f/P.v Rapid Test Kit

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616718
Basic UDI-DI: B-08697962616718
Reference: SFMPFPV
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:22

Manufacturer products View details

08693285187676

Malaria Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187676
Basic UDI-DI: B-08693285187676
Reference: TIML01001
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:33

Manufacturer products View details

08693285187317

Malaria Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187317
Basic UDI-DI: B-08693285187317
Reference: TIML01010
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details

08693285187041

Malaria Test

IVD generalIVDDOn the marketAnimal tissuesKitSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187041
Basic UDI-DI: B-08693285187041
Reference: TIML01
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:31

Manufacturer products View details

08693285182183

Malaria Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285182183
Basic UDI-DI: B-08693285182183
Reference: IML01
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:27

Manufacturer products View details

08693285182060

Malaria Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285182060
Basic UDI-DI: B-08693285182060
Reference: TML01
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:27

Manufacturer products View details

08693285181940

Malaria Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181940
Basic UDI-DI: B-08693285181940
Reference: RTML01
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:26

Manufacturer products View details

RapidFor™ Malaria P.f. (pLDH) Rapid Test Kit

VMD127

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030639
Basic UDI-DI: B-08684595030639
Reference: VMD127
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:14

Manufacturer products View details

ChainFor Malaria Detection qPCR Kit

CFP98

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257949
Basic UDI-DI: B-08683548257949
Reference: CFP98
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:17

Manufacturer products View details

RapidFor™ Malaria P.f. (HRP2) Rapid Test Kit

VMD20

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941278
Basic UDI-DI: B-08683347941278
Reference: VMD20
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:04

Manufacturer products View details

Malaria P.f/Pan Test (GICA)

25T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139078167
Basic UDI-DI: B-06978139078167
Reference: 0320321202
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 07.07.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

06977903341827

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903341827
Basic UDI-DI: B-06977903341827
Reference: GS110401C25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details