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308 device results listed.

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CHAGAS WB IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-37700277931822C
Basic UDI-DI: B-37700277931822C
Reference: CHA-WB96G
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:56

Manufacturer products View details

CHAGAS WB IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-37700277931752F
Basic UDI-DI: B-37700277931752F
Reference: CHA-WB24G
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:56

Manufacturer products View details

CHAGAS WB IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-37700277931682J
Basic UDI-DI: B-37700277931682J
Reference: CHA-WB12G
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:56

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SCHISTOSOMA ICT IgG-IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-377002779314424
Basic UDI-DI: B-377002779314424
Reference: BILZ Ab ICT100
EMDN: W0105050206
EMDN description: SCHISTOSOMA
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:56

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SCHISTOSOMA ICT IgG-IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-377002779313727
Basic UDI-DI: B-377002779313727
Reference: BILZ Ab ICT20
EMDN: W0105050206
EMDN description: SCHISTOSOMA
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:56

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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

08800204300263

RADI Kala-azar (Leishmania) Detection KIT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300263
Basic UDI-DI: B-08800204300263
Reference: RB003
EMDN: W0105050205
EMDN description: LEISHMANIA
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

RapidFor™ Giardia lamblia (FIA)

VMPO107GAD

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277655
Basic UDI-DI: B-08684998277655
Reference: VMPO107
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:21

Manufacturer products View details

RapidFor™ Leishmenia Ab Rapid Test Kit

VMD113

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030516
Basic UDI-DI: B-08684595030516
Reference: VMD113
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:14

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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

LyoSens Blastocystis hominis + Dientamoeba fragilis Detection qPCR Kit

LYO31

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258854
Basic UDI-DI: B-08683548258854
Reference: LYO31
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:20

Manufacturer products View details

LyoSens Cryptosporidium, Giardia & E. Histolytica Detection qPCR Kit

LYO32

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258861
Basic UDI-DI: B-08683548258861
Reference: LYO32
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:20

Manufacturer products View details

LyoSens Dientamoeba fragilis Detection qPCR Kit

LYO21

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258755
Basic UDI-DI: B-08683548258755
Reference: LYO21
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:19

Manufacturer products View details