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Emdyca

Manufacturer

Optovue

United StatesLegal entities : Optovue, Inc.

Markets : France · United States

Approvals : EU – class IIa · United States (FDA) – 510(k) : 16 · class I, II · latest in 2022 · see on the FDA website

EU representative : MDSS GmbH (Germany)

Website regulatory@optovue.com

1 category, 2 models including 2 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Optical consistency tomographs Z12120121 IIa MDR 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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