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Emdyca

Manufacturer

Nantong EgensBiotechnology

ChinaLegal entities : Nantong EgensBiotechnology Co.,Ltd.

Markets : United States

Approvals : United States (FDA) – 510(k) : 1 · class I, II · latest in 2024 · see on the FDA website

EU representative : SUNGO Europe B.V. (Netherlands)

qa@egens-bio.cn

10 categories, 27 models including 0 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Viral antigen/antibody detection - other No model still on the market W0105040699
9 others
 – 98/79 EUDAMED record Report an error
Dengue virus No model still on the market W0105040611 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) - RT & POC No model still on the market W0105090401 – 98/79 EUDAMED record Report an error
H. pylori antibody assays No model still on the market W0105010402 – 98/79 EUDAMED record Report an error
H. pylori antigen detection No model still on the market W0105010401 – 98/79 EUDAMED record Report an error
Hav antibody igm No model still on the market W0105020104 – 98/79 EUDAMED record Report an error
Influenza a and /or b - RT & POC No model still on the market W0105099004 – 98/79 EUDAMED record Report an error
IVD general use consumable devices - other No model still on the market W0599 – 98/79 EUDAMED record Report an error
Salmonella antibody assays No model still on the market W0105011002 – 98/79 EUDAMED record Report an error
Syphilis antibody assays total No model still on the market W0105010302 – 98/79 EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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