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Emdyca

Manufacturer

OSANG Healthcare

South KoreaLegal entities : OSANG Healthcare Co., Ltd

Markets : Austria · Bulgaria · Croatia · Czechia · Germany · Greece · Italy · Poland · Portugal · Romania · Slovakia · Slovenia · Sweden · United States

Approvals : EU – class A, C · United States (FDA) – 510(k) : 3 · class I, II · latest in 2021 · see on the FDA website

EU representative : Obelis s.a. (Belgium)

Website

4 categories, 46 models including 46 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Blood glucose meters W0201060102
34 others
C IVDR, 98/79 EUDAMED record Report an error
Glycosilated hemoglobin devices W0201060101 A IVDR, 98/79 EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents W0105070501 – 98/79 EUDAMED record Report an error
Various diabetes monitoring instruments - other W020106019099 A IVDR 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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