Manufacturer

Shenzhen Aeon Technology

ChinaLegal entities : Shenzhen Aeon Technology Co., Ltd.

Markets : Finland · Germany · Greece · Iceland · Ireland · Italy · Netherlands · Northern Ireland · Poland · Spain · Türkiye · United States

Approvals : EU – class IIa · United States (FDA) – 510(k) : 3 · class II · latest in 2020 · see on the FDA website

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

6 categories, 21 models including 21 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Aerosol equipment	Z12159002	Compressor Nebulizer A500LW0093/42 Compressor Nebulizer A500LW0193/42 Compressor Nebulizer A500LW0293/42 Compressor Nebulizer A500LW0393/42 Compressor Nebulizer A500LW0493/42 10 others Compressor Nebulizer A500LW0593/42 Compressor Nebulizer A500LW0693/42 Compressor Nebulizer A500LW0793/42 Compressor Nebulizer A500LW0893/42 Compressor Nebulizer A500LW0993/42 Compressor Nebulizer A500LW1093/42 Compressor Nebulizer A500LW1193/42 Compressor Nebulizer A500LW1293/42 Compressor Nebulizer A500LWD93/42 Compressor Nebulizer A500LWD01, A500LWD02, A500LWD04, A500LWD05, A500LWDC01, A500LWDC02, A500LWDC04, A500LWDC053 refs	IIa MDR, 93/42	EUDAMED record Report an error
Pulse oximeters	Z1203020408	Pulse Oximeter A300, A310, A320, A330, A340, A310L, A340L3 refs Pulse Oximeter A31093/42	IIa MDR, 93/42	EUDAMED record Report an error
ECG holter recorders	Z12050403	ECG RECORDER HeartPATCH-BT	IIa MDR	EUDAMED record Report an error
Muscle reinforcement stimulators for innervated muscles	Z12062801	TENS/EMS UnIT A620, A621, A622, A620P, A621P, A622P, A620W, A621W, A622W3 refs	IIa MDR	EUDAMED record Report an error
Thermometers - other	V03010199	Infrared Thermometer A200, A201, A202, A201F, A201W, A202W, A202C, A202D, A202E, A202F3 refs	IIa MDR	EUDAMED record Report an error
Various pneumology and respiratory physiopathology instruments - consumables	Z12159085	Nebulizer kit A-DA013 refs	IIa 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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