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Emdyca

Manufacturer

Goldsite

ChinaLegal entities : Goldsite Diagnostics Inc.

First countries of placing on the market declared in EUDAMED : Italy

EU representative : CMC Medical Devices & Drugs SL (Spain)

Website export@goldsite.com.cn

13 categories, 29 models including 29 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Immunochemistry instruments - other W02010299
1 other
 A IVDR EUDAMED record Report an error
D-dimer W0103020503 – 98/79 EUDAMED record Report an error
Glycosilated hemoglobin devices W0201060101 A IVDR EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents W0105070304 – 98/79 EUDAMED record Report an error
Antithrombin W0103020602 – 98/79 EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids) W0103010105 A IVDR EUDAMED record Report an error
Haematology controls - other W0103010599 – 98/79 EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400) W0201010101 A IVDR EUDAMED record Report an error
Haemoglobin controls W0103010504 – 98/79 EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 – 98/79 EUDAMED record Report an error
Monkeypox virus / mpox RT & POC W0105099008 – 98/79 EUDAMED record Report an error
Other haemoglobin (types) testing - other W0103010299 A IVDR, 98/79 EUDAMED record Report an error
Whole blood calibrators W0103010507 – 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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