- 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
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
01.08.2026 18:27
Sync status
Successful
Device
2989865
Actor
47523
Certificate
3174
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
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
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
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
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
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
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
Malaria Antigen Rapid Test Kit (Colloidal gold method)
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
Malaria pf/pan Rapid Test Kit(Colloidal gold method)
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
Malaria Antibody Rapid Test Kit (Colloidal gold method)
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
Malaria pf/pv Antigen Rapid Test Kit (Colloidal gold method)
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
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
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
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
Access Toxo IgG
Access Toxo IgG
IVD Annex II List BIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
- Manufacturer
- Beckman Coulter Inc.
- Manufacturer SRN
- US-MF-000010288
- UDI-DI
- D-A31588UG
- Basic UDI-DI
- B-A31588UG
- Reference
- A31588
- EMDN
- W0105050102
- EMDN description
- TOXOPLASMA ANTIBODY IGG
- First on market country
- Ireland
- Authorised representative
- Beckman Coulter Ireland Inc.
- Last updated
- 12.07.2026 21:15
Cryptosporidium parvum
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
Entamoeba histolytica
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
Giardia
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
FASCIOLA ES WB IgG
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
FASCIOLA ES WB IgG
FASCIOLA ES WB IgG
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- LDBIO DIAGNOSTICS
- Manufacturer SRN
- FR-MF-000021697
- UDI-DI
- D-37700277935332K
- Basic UDI-DI
- B-37700277935332K
- Reference
- FAS ES-WB24G
- EMDN
- W0105050203
- EMDN description
- DISTOMATOSIS
- First on market country
- France
- Authorised representative
- -
- Last updated
- 11.07.2026 18:57