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Emdyca

Manufacturer

Hangzhou Hawk Optical Electronic Instruments

ChinaLegal entities : Hangzhou Hawk Optical Electronic Instruments Co.,Ltd.

Markets : Austria · Belgium · Bulgaria · Cyprus · Finland · France · Italy · Netherlands · Poland · Romania · Slovakia · Spain · Türkiye · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 2 · class II · latest in 2026 · see on the FDA website

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

Website

18 categories, 48 models including 48 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Morcellators Z12080204
7 others
IIa MDR, 93/42 EUDAMED record Report an error
Genitourinary endoscopy instruments - hardware accessories Z12020780
1 other
I MDR EUDAMED record Report an error
Nephroscopes Z12020705 IIa MDR, 93/42 EUDAMED record Report an error
Video processors Z12020406 I MDR EUDAMED record Report an error
Cystoscopes Z12020701 I, IIa MDR EUDAMED record Report an error
Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - other Z12020499 I MDR EUDAMED record Report an error
Ureterorenoscopes Z12020713 I, IIa MDR EUDAMED record Report an error
Cleaning, disinfection and sterilisation instruments - other Z12011399 I MDR EUDAMED record Report an error
Video nasopharyngo/laryngoscopes Z12021006 I MDR EUDAMED record Report an error
Cystourethroscopes Z12020702 I MDR EUDAMED record Report an error
Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - hardware accessories Z12020480 I MDR EUDAMED record Report an error
Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images Z12020401 I MDR EUDAMED record Report an error
Light sources Z129004 I MDR EUDAMED record Report an error
Light sources for endoscopy and minimally invasive surgery Z12020402 I MDR EUDAMED record Report an error
Medical support equipment - accessories V0880 I MDR EUDAMED record Report an error
Middle ear otoscopes Z12021007 I MDR EUDAMED record Report an error
Modules for endoscopic imaging and minimally invasive surgery Z12020403 I MDR EUDAMED record Report an error
Rhinoscopes Z12021008 I 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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