Manufacturer

Atom Medical

JapanLegal entities : Atom Medical Corporation

Markets : Italy · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 15 · class I, II · latest in 2013 · see on the FDA website

EU representative : Emergo Europe B.V. (Netherlands)

7 categories, 20 models including 20 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Fixed neonatal incubators	Z1208040301	"Incu I w/o O2 Controller Unit, AC230V"93/42 Air Incu i w/ Humidity Controller, AC230V93/42 Dual lncu I w/ O2 Controller Unit, AC230V Dual Incu i w/O2 Controller Unit93/42 Dual lncu I w/o O2 Controller Unit, AC230V Dual Incu i w/o O2 Controller Unit93/42 Incu I Main Unit Only,w/ O2 Controller, AC230V Incu i w/O2 Controller Unit, Main unit93/42 2 others Incu I Main Unit Only,w/o O2 Controller, AC230V Incu i w/o O2 Controller Unit, Main unit93/42 Incu I w/ O2 Controller Unit, AC230V93/42	IIb 93/42	EUDAMED record Report an error
Neonatal radiant warmers	Z12080407	Sunflower Warmer Cabinet/Tilt, AC230V93/42 Sunflower Warmer Hi-Low/Tilt, AC230V93/42 Sunflower Warmer Stand, AC230V93/42 Sunflower Warmer Wall Mount, AC230V93/42 Z1208040793/42	IIb 93/42	EUDAMED record Report an error
Paediatric phototherapy equipment	Z12080401	BILI-THERAPY Pad Type93/42 BILI-THERAPY Spot Type Arm Type for F-Rail93/42 BILI-THERAPY Spot Type Mount Type93/42 BILI-THERAPY Spot Type Stand Type93/42	IIa 93/42	EUDAMED record Report an error
Light sources	Z129004	InfaLite	I MDR	EUDAMED record Report an error
Mobile neonatal incubators	Z1208040302	IncuArch93/42	IIb 93/42	EUDAMED record Report an error
Neonatology instruments - hardware accessories	Z12080480	I.V. Pole	I MDR	EUDAMED record Report an error
Treatment, diagnosis and monitoring medical beds	V080603	Neo Cot	I MDR	EUDAMED record Report an error

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