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DRGEM Corporation

South Korea·KR-MF-000017990

Last updated September 17, 2026

Information

Country: South Korea
Address: 60, Haan-ro, Gwangmyeong, South Korea
Website: www.drgemhealthcare.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +82 70 8230 8561
PRRC Contact: Sung-hee Park
EUDAMED SRN: KR-MF-000017990
FDA FEI Number: 3006551157
DUNS Number: 688477319

Catalogue (377)

Page 1 of 8

Device	Model / Reference	Registries	Class	Status
FDR Smart FGXR-Z52S	FDR Smart FGXR-Z52S	EUDAMED	Class IIb	Active
Diamond-5b	DIAMOND-5B	EUDAMED	Class IIb	Active
FDR Smart FGXR-E20S	FDR Smart FGXR-E20S	EUDAMED	Class IIb	Active
Diamond-6b	DIAMOND-6B	EUDAMED	Class IIb	Active
FDR Smart FGXR-EC20S	FDR Smart FGXR-EC20S	EUDAMED	Class IIb	Active
Diamond-8b	DIAMOND-8B	EUDAMED	Class IIb	Active
FDR Smart FGXR-EC32S	FDR Smart FGXR-EC32S	EUDAMED	Class IIb	Active
Diamond-5b	DIAMOND-5B	EUDAMED	Class IIb	Active
FDR Smart FGXR-EC50S	FDR Smart FGXR-EC50S	EUDAMED	Class IIb	Active
FDR Smart FGXR-EC25S	FDR Smart FGXR-EC25S	EUDAMED	Class IIb	Active
FDR Smart FGXR-EC40S	FDR Smart FGXR-EC40S	EUDAMED	Class IIb	Active
FDR Smart FGXR-EC50S	FDR Smart FGXR-EC50S	EUDAMED	Class IIb	Active
Diamond-5b	DIAMOND-5B	EUDAMED	Class IIb	Active
Diamond-8b	DIAMOND-8B	EUDAMED	Class IIb	Active
FDR Smart FGXR-EC25S	FDR Smart FGXR-EC25S	EUDAMED	Class IIb	Active
FDR Smart FGXR-Z68S	FDR Smart FGXR-Z68S	EUDAMED	Class IIb	Active
FDR Smart FGXR-Z82S	FDR Smart FGXR-Z82S	EUDAMED	Class IIb	Active
FDR Smart FGXR-EC32S	FDR Smart FGXR-EC32S	EUDAMED	Class IIb	Active
Diamond-5b	DIAMOND-5B	EUDAMED	Class IIb	Active
FDR Smart FGXR-Z52S	FDR Smart FGXR-Z52S	EUDAMED	Class IIb	Active
FDR Smart FGXR-Z82S	FDR Smart FGXR-Z82S	EUDAMED	Class IIb	Active
FDR Smart FGXR-E40S	FDR Smart FGXR-E40S	EUDAMED	Class IIb	Active
FDR Smart FGXR-E32S	FDR Smart FGXR-E32S	EUDAMED	Class IIb	Active
FDR Smart FGXR-EC20S	FDR Smart FGXR-EC20S	EUDAMED	Class IIb	Active
Diamond-6b	DIAMOND-6B	EUDAMED	Class IIb	Active
FDR Smart FGXR-Z52S	FDR Smart FGXR-Z52S	EUDAMED	Class IIb	Active
FDR Smart FGXR-Z68S	FDR Smart FGXR-Z68S	EUDAMED	Class IIb	Active
FDR Smart FGXR-Z68S	FDR Smart FGXR-Z68S	EUDAMED	Class IIb	Active
Diamond-8b	DIAMOND-8B	EUDAMED	Class IIb	Active
Drgem	TS-FC2	FDA UDI	Class I	Active
Drgem	GXR-C40S	EUDAMEDFDA UDI	Class II	Active
Drgem	GXR-U40SD	EUDAMEDFDA UDI	Class II	Active
Drgem	FDR Smart FGXR-32S	EUDAMEDFDA UDI	Class II	Active
Drgem	GXR-C32	FDA UDI	Class I	Active
Drgem	SGXR-C40S	FDA UDI	Class II	Active
Drgem	SGXR-40S	FDA UDI	Class II	Active
Drgem	SGXR-C32SD	FDA UDI	Class II	Active
Drgem	GXR-40SD	EUDAMEDFDA UDI	Class II	Active
Drgem	GXR-C40	FDA UDI	Class I	Active
FDR Clinica	FDR Clinica FGXR-C40S	FDA UDI	Class II	Active
Drgem	FDR Smart FGXR-32S	EUDAMEDFDA UDI	Class II	Active
Drgem	FDR Smart FGXR-32S	EUDAMEDFDA UDI	Class II	Active
Drgem	GXR-C52SD	EUDAMEDFDA UDI	Class II	Active
Drgem	SGXR-32S	FDA UDI	Class II	Active
Drgem	SGXR-40S	FDA UDI	Class II	Active
Drgem	FDR Smart FGXR-40S	EUDAMEDFDA UDI	Class II	Active
FDR Clinica	FDR Clinica FGXR-C52S	FDA UDI	Class II	Active
Drgem	SGXR-C52S	FDA UDI	Class II	Active
GXR-ES, ECS Diagnostic X-ray System	GXR-EC40S	EUDAMEDFDA UDI	Class II	Active
Drgem	GXR-52SD	EUDAMEDFDA UDI	Class II	Active

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