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Emdyca

Manufacturer

General Life Biotechnology

TaiwanLegal entities : General Life Biotechnology Co., Ltd.

Markets : Bulgaria · Germany · Spain · United States

Approvals : EU – class C · United States (FDA) – 510(k) : 1 · class I, II · latest in 2013 · see on the FDA website

EU representative : MDSS GmbH (Germany)

Website service@glbiotech.com.tw

6 categories, 54 models including 41 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Various rapid test chemistry / immunochemistry instruments - other W0201069099
33 others
C IVDR, 98/79 EUDAMED record Report an error
Blood glucose meters W0201060102
3 others
– 98/79 EUDAMED record Report an error
Haematology controls - RT & POC W0103010606 – 98/79 EUDAMED record Report an error
Rapid test hematology / histology / cytology instruments - other W02020699 – 98/79 EUDAMED record Report an error
Various diabetes monitoring instruments - other W020106019099 – 98/79 EUDAMED record Report an error
Haemoglobin (hb) W0103010601 – 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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