Manufacturer

AMI

Austria, South KoreaLegal entities : A.M.I. Agency for Medical Innovations GmbH, AMI INC.

First countries of placing on the market declared in EUDAMED : Germany, Lithuania, Netherlands, Poland, Portugal, Spain, Türkiye

Public contracts won : France 24

EU representative : Obelis s.a. (Belgium)

9 categories, 31 models including 31 on the market, 2 countries

Category	EMDN code	Registered models	Class	Contact
Neodymium surgical laser	Z12011017	ALLUX-Q93/42 ALLUX-Q PLUS93/42 PICO LEGEND93/42 PICO MASTER93/42 Q-MASTER93/42 3 others Q-MASTER PLUS93/42 REX-Q93/42 REX-Q PLUS93/42	IIb 93/42	EUDAMED record Report an error
Carbon dioxide surgical laser	Z12011005	BIOXEL93/42 BX30093/42 DERMAXEL93/42 DI-REX93/42 DX30093/42 2 others NEOXEL93/42 REX-CO93/42	IIb 93/42	EUDAMED record Report an error
Dye/alexandrite surgical laser	Z12011012	ALLUX ALEX93/42 ALLUX DUAL93/42 ALLUX Nd:YAG93/42 REX-AN ALEX93/42 REX-AN DUAL93/42 1 other REX-AN Nd:YAG93/42	IIb 93/42	EUDAMED record Report an error
Electrosurgical units (ESU) for general use	Z12010902	ANTIGE93/42 MT-SMART93/42	IIb 93/42	EUDAMED record Report an error
Gynaecology and fertility treatment instruments - other	Z12080299	i-Cut ICT5011 i-Cut Power Supply	I, IIa MDR	EUDAMED record Report an error
Phototherapy equipment	Z12040202	REX-LIGHT93/42 SOLRAY93/42	IIa 93/42	EUDAMED record Report an error
Ultrasound therapy equipment	Z120610	HI-REX93/42 VIOLA93/42	IIa 93/42	EUDAMED record Report an error
Cleaning and disinfection equipment	Z12011301	i-Stitch Cleaning Brush3 refs	I MDR	EUDAMED record Report an error
Diode surgical laser	Z12011016	HACLRE93/42	IIb 93/42	EUDAMED record Report an error

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