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Emdyca

Manufacturer

Apolo

ChinaLegal entities : Shanghai Apolo Medical Technology Co., Ltd.

Markets : Bulgaria · Croatia · Czechia · France · Germany · Italy · Poland · Spain · United States

Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 14 · class II · latest in 2026 · see on the FDA website

EU representative : Lotus NL B.V. (Netherlands)

7 categories, 26 models including 26 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Diode surgical laser Z12011016
3 others
IIb 93/42 EUDAMED record Report an error
Phototherapy equipment Z12040202
2 others
IIa, IIb 93/42 EUDAMED record Report an error
Diode-pumped solid-state (dpss) surgical laser Z12011006 IIb 93/42 EUDAMED record Report an error
Carbon dioxide surgical laser Z12011005 IIb 93/42 EUDAMED record Report an error
Dye surgical laser Z12011007 IIb 93/42 EUDAMED record Report an error
Laser surgery instruments - other Z12011099 IIb 93/42 EUDAMED record Report an error
Multi-platform laser Z12011019 IIb 93/42 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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