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Emdyca

Manufacturer

Boston Scientific

United StatesLegal entities : Boston Scientific Corporation

Markets : Austria · Belgium · Denmark · Finland · France · Greece · Italy · Netherlands · Norway · Poland · Portugal · Spain · Sweden · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 739 · PMA : 76 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : France 964 · Italy 143 · Sweden 39 · Greece 26 · Finland 17 · Netherlands 16 · Belgium 14 · Denmark 8 · Portugal 7 · Spain 6 · Austria 5 · Poland 3 and 1 more countries

EU representative : Boston Scientific Limited (Ireland)

Website eudamed@bsci.com

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

Export to CSV
CategoryEMDN codeRegistered modelsClassContact
Cryosurgery equipment Z120102 IIa, IIb MDR EUDAMED record Report an error
Genitourinary endoscopy instruments - hardware accessories Z12020780 I, IIa MDR EUDAMED record Report an error
Laser surgery instruments - consumables Z12011085 IIa MDR EUDAMED record Report an error
Diode-pumped solid-state (dpss) surgical laser Z12011006 IIa MDR EUDAMED record Report an error
Video choledocoscopes Z12020507 IIa MDR EUDAMED record Report an error
Electrosurgery instruments - other Z12010999 IIb MDR EUDAMED record Report an error
Endoscopic lithotripsy instruments - hardware accessories Z12020380 I MDR EUDAMED record Report an error
Equipment for liquid prostate thermotherapy Z12160302 IIb MDR, 93/42 EUDAMED record Report an error
Genitourinary endoscopy instruments - other Z12020799 I 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
Laser surgery instruments - other Z12011099 IIb MDR EUDAMED record Report an error
Prostate thermotherapy instruments - consumables Z12160385 IIb MDR EUDAMED record Report an error
Surgical medical aspirators Z120105 IIb MDR EUDAMED record Report an error
Uteroscopes Z12020709 IIa MDR EUDAMED record Report an error
Video duodenoscopes Z12020508 IIa MDR EUDAMED record Report an error
Video processors Z12020406 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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