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Emdyca

Manufacturer

S.D. Sight Diagnostics

IsraelLegal entities : S.D. Sight Diagnostics Ltd

Markets : Northern Ireland · United States

Approvals : United States (FDA) – 510(k) : 1 · class II · latest in 2022 · see on the FDA website

EU representative : CEpartner4U (Netherlands)

Website info@sightdx.com

2 categories, 2 models including 0 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) No model still on the market W0202010101 – 98/79 EUDAMED record Report an error
Complete cell count No model still on the market W0103010103 – 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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