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Emdyca

Manufacturer

Biotime

ChinaLegal entities : Xiamen Biotime Biotechnology Co., Ltd.

First countries of placing on the market declared in EUDAMED : Germany, Netherlands, Spain

EU representative : Medunion S.L. (Spain)

18 categories, 44 models including 4 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Various rapid test chemistry / immunochemistry instruments - other W0201069099
4 others
 A IVDR EUDAMED record Report an error
Viral antigen/antibody detection - other No model still on the market W0105040699
3 others
 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) No model still on the market W0105050209 – 98/79 EUDAMED record Report an error
Dengue virus No model still on the market W0105040611 – 98/79 EUDAMED record Report an error
Rapid test hematology / histology / cytology instruments - other No model still on the market W02020699 A IVDR EUDAMED record Report an error
Virology - RT & POC - other No model still on the market W0105099099 – 98/79 EUDAMED record Report an error
D-dimer No model still on the market W0103020503 – 98/79 EUDAMED record Report an error
Platelets No model still on the market W0103010605 – 98/79 EUDAMED record Report an error
Adenovirus No model still on the market W0105040601 – 98/79 EUDAMED record Report an error
Glycosilated hemoglobin devices No model still on the market W0201060101 A IVDR EUDAMED record Report an error
Influenza & para influenza No model still on the market W0105040604
  • BIOTIME3 refs98/79 (no longer marketed)
 – 98/79 EUDAMED record Report an error
Interleukin 6 (il-6) No model still on the market W01030609 – 98/79 EUDAMED record Report an error
Mycoplasma antibody assays No model still on the market W0105010802 – 98/79 EUDAMED record Report an error
Mycoplasma antigen detection No model still on the market W0105010801 – 98/79 EUDAMED record Report an error
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus No model still on the market W0105900102 – 98/79 EUDAMED record Report an error
Respiratory syncytial virus (rsv) No model still on the market W0105040605 – 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
Virology reagents - other No model still on the market W01050499 – 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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