Manufacturer

SG Healthcare

South KoreaLegal entities : SG Healthcare Co.,Ltd

Markets : Spain · United States

Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 3 · class I, II · latest in 2023 · see on the FDA website

EU representative : CMC Medical Devices & Drugs SL (Spain)

7 categories, 12 models including 12 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Computed tomographs - 16 layers or more but less than 64 layers	Z11030603	DOMINUS93/42 DOMINUS 3293/42 DOMINUS1693/42	IIb 93/42	EUDAMED record Report an error
Various radiodiagnostic and interventional instruments - hardware accessories	Z11039080	JUMONG MOBILE93/42 JUMONG RETRO93/42 JUMONG RETRO COMFORT93/42	IIa 93/42	EUDAMED record Report an error
Multifunctional systems for direct digital radiology	Z11031101	JUMONG93/42 JUMONG X (X: A~Z)93/42	IIb 93/42	EUDAMED record Report an error
Computed tomographs - 128 layers or more but less than 256 layers	Z11030606	DOMINUS 12893/42	IIb 93/42	EUDAMED record Report an error
Computed tomographs - 64 layers or more but less than 128 layers	Z11030605	DOMINUS 6493/42	IIb 93/42	EUDAMED record Report an error
Fluoroscopy devices	Z11039009	GARION2 refs	IIb MDR	EUDAMED record Report an error
Multifunctional systems for traditional radiology	Z110310	JUMONG GENERAL2 refs93/42	IIb 93/42	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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