Manufacturer

Ningbo Xinwell Medical Technology

ChinaLegal entities : Ningbo Xinwell Medical Technology Co., Ltd

Markets : Austria · Germany · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 2 · class I, II · latest in 2024 · see on the FDA website

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

4 categories, 4 models including 4 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Cystoscopes	Z12020701	Single-use Digital Flexible Cystoscopes XY-SC42S-0S, XY-SC42S-1S, XY-SC42S-0R, XY-SC42S-1R, XY-SC54S-0S, XY-SC54S-1S, XY-SC54S-0R, XY-SC54S-1R3 refs	IIa MDR	EUDAMED record Report an error
Ureterorenoscopes	Z12020713	Single-Use Digital Flexible Ureteroscopes XY-S600-A，XY-S600-B，XY-L600-A，XY-L600-B，XY-S630-A，XY-S630-B，XY-L630-A，XY-L630-B，XY-S650-A，XY-S650-B，XY-L650-A，XY-L650-B3 refs	IIa MDR	EUDAMED record Report an error
Video laryngoscopes	Z12021004	Video Laryngoscopes XY-204-A1	IIa MDR	EUDAMED record Report an error
Video processors	Z12020406	Image Processor XY-600B	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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