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308 device results listed.

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Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma)

GCKal-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCKal-401aHGWJ
Basic UDI-DI: B-GCKal-401aHGWJ
Reference: GCKal-401a
EMDN: W0105050205
EMDN description: LEISHMANIA
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

Giardia lamblia Antigen Rapid Test Cassette (Feces)

GCGIA-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCGIA-602aT3
Basic UDI-DI: B-GCGIA-602aT3
Reference: GCGIA-602a
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Giardia lamblia Antigen Rapid Test Cassette (Feces)

GCGIA-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCGIA-602aHGPM
Basic UDI-DI: B-GCGIA-602aHGPM
Reference: GCGIA-602a
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

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Chagas Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCCHA-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCHA-402aPQ
Basic UDI-DI: B-GCCHA-402aPQ
Reference: GCCHA-402a
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:23

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Chagas Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCCHA-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCHA-402aHGJG
Basic UDI-DI: B-GCCHA-402aHGJG
Reference: GCCHA-402a
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Chagas Ab Rapid Test Cassette (Serum/Plasma)

GCCHA-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCHA-302aPH
Basic UDI-DI: B-GCCHA-302aPH
Reference: GCCHA-302a
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Chagas Ab Rapid Test Cassette (Serum/Plasma)

GCCHA-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCHA-302aHGJ3
Basic UDI-DI: B-GCCHA-302aHGJ3
Reference: GCCHA-302a
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

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RapiT.Cruzi Rapid Antibody Test kit for Trypanosoma cruzi

G2MR172550

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2MR172550JR
Basic UDI-DI: B-G2MR172550JR
Reference: G2MR172550, G2MR170150R
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:46

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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

Malaria Antibody 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-CNMF000054349CR046GT
Basic UDI-DI: B-CNMF000054349CR046GT
Reference: CR046
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/pv 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-CNMF000054349CR002G7
Basic UDI-DI: B-CNMF000054349CR002G7
Reference: CR002
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Entamoeba histolytica Strip (Feces)

Strip

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A292VD
Basic UDI-DI: B-ABT-IDT-A292VD
Reference: ABT-IDT-A292
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
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® Giardia lamblia Strip (Feces)

Strip

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A255V7
Basic UDI-DI: B-ABT-IDT-A255V7
Reference: ABT-IDT-A255
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
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® Chagas Strip (Whole Blood/Serum/Plasma)

Strip

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A219V3
Basic UDI-DI: B-ABT-IDT-A219V3
Reference: ABT-IDT-A219
EMDN: W0105050202
EMDN description: CHAGAS
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

Cryptosporidium parvum

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313275854
Basic UDI-DI: B-86060313275854
Reference: C1804V24CP
EMDN: W0105050207
EMDN description: CRYPTOSPORIDIUM
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

Entamoeba histolytica

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313275786
Basic UDI-DI: B-86060313275786
Reference: C1805V24EH
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

Giardia

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313275618
Basic UDI-DI: B-86060313275618
Reference: C1806V24GIA
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

FASCIOLA ES WB IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-37700277935402G
Basic UDI-DI: B-37700277935402G
Reference: FAS ES-WB96G
EMDN: W0105050203
EMDN description: DISTOMATOSIS
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:57

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