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609 device results listed.

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Toxoplasma gondii (Toxo) IgG/IgM Rapid Test

GCTOX(IgG/IgM)-302a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCTOX(IgG/IgM)-302a4G
Basic UDI-DI: B-GCTOX(IgG/IgM)-302a4G
Reference: GCTOX(IgG/IgM)-302a
EMDN: W0105050101
EMDN description: TOXOPLASMA ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Toxoplasma gondii (Toxo) IgG Rapid Test

GCTOX(IgG)-302a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCTOX(IgG)-302a8K
Basic UDI-DI: B-GCTOX(IgG)-302a8K
Reference: GCTOX(IgG)-302a
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCKal-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCKal-T402aYL
Basic UDI-DI: B-GCKal-T402aYL
Reference: GCKal-T402a
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

Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCKal-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCKal-T402aHGQK
Basic UDI-DI: B-GCKal-T402aHGQK
Reference: GCKal-T402a
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

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

GCKal-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCKal-402aNM
Basic UDI-DI: B-GCKal-402aNM
Reference: GCKal-402a
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

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

GCKal-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCKal-402aHGWR
Basic UDI-DI: B-GCKal-402aHGWR
Reference: GCKal-402a
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

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

GCKal-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCKal-401aNJ
Basic UDI-DI: B-GCKal-401aNJ
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

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

D-EIM4415117GL

TOXO IgM Antibody Chemiluminescent Immunoassay Kit

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4415117GL
Basic UDI-DI: B-EIM4415117GL
Reference: EIM4415117
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4415116GJ

TOXO IgG Antibody Chemiluminescent Immunoassay Kit

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4415116GJ
Basic UDI-DI: B-EIM4415116GJ
Reference: EIM4415116
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4411117FQ

TOXO IgM Antibody Chemiluminescent Immunoassay Kit

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4411117FQ
Basic UDI-DI: B-EIM4411117FQ
Reference: EIM4411117
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:58

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