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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 7 of 8

Device	Model / Reference	Registries	Class	Status
Drgem	PBT-6	FDA UDI	Class II	Active
FDR Clinica	FDR Clinica FGXR-32S	FDA UDI	Class II	Active
Drgem	GXR-32S	EUDAMEDFDA UDI	Class II	Active
Drgem	SGXR-82S	FDA UDI	Class II	Active
Drgem	GXR-32S	EUDAMEDFDA UDI	Class II	Active
FDR Clinica	FDR Clinica FGXR-C52S	FDA UDI	Class II	Active
Drgem	SGXR-C40SD	FDA UDI	Class II	Active
Drgem	PBT-4	FDA UDI	Class II	Active
Drgem	GXR-C52S	EUDAMEDFDA UDI	Class II	Active
Drgem	SGXR-C32SD	FDA UDI	Class II	Active
Drgem	SGXR-40S	FDA UDI	Class II	Active
Drgem	GXR-52	FDA UDI	Class I	Active
Drgem	GXR-C52SD	EUDAMEDFDA UDI	Class II	Active
Drgem	FDR Smart FGXR-U40S	EUDAMEDFDA UDI	Class II	Active
Drgem	GXR-C32	FDA UDI	Class I	Active
Drgem	FDR Smart FGXR-40S	EUDAMEDFDA UDI	Class II	Active
Drgem	FDR Smart FGXR-C32S	EUDAMEDFDA UDI	Class II	Active
Drgem	GXR-82SD	EUDAMEDFDA UDI	Class II	Active
Drgem	SGXR-40SD	FDA UDI	Class II	Active
Drgem	FDR Smart FGXR-U32S	EUDAMEDFDA UDI	Class II	Active
Drgem	SGXR-C52S	FDA UDI	Class II	Active
Drgem	GXR-32SD	EUDAMEDFDA UDI	Class II	Active
Drgem	GXR-32SD	EUDAMEDFDA UDI	Class II	Active
Drgem	SGXR-40SD	FDA UDI	Class II	Active
GXR-ES, ECS Diagnostic X-ray System	GXR-EC50S	EUDAMEDFDA UDI	Class II	Active
Drgem	SGXR-82SD	FDA UDI	Class II	Active
Drgem	GXR-40S	EUDAMEDFDA UDI	Class II	Active
Drgem	FDR Smart FGXR-32S	EUDAMEDFDA UDI	Class II	Active
Drgem	PROMO	FDA UDI	Class II	Active
Drgem	GXR-E25	FDA UDI	Class I	Active
Drgem	GXR-52S	EUDAMEDFDA UDI	Class II	Active
Drgem	GXR-68	FDA UDI	Class I	Active
Drgem	GXR-EC40	FDA UDI	Class I	Active
Drgem	SGXR-32SD	FDA UDI	Class II	Active
Drgem	FDR Smart FGXR-U32S	EUDAMEDFDA UDI	Class II	Active
Drgem	SGXR-32SD	FDA UDI	Class II	Active
Drgem	FDR Smart FGXR-C52S	EUDAMEDFDA UDI	Class II	Active
Drgem	SGXR-C40SD	FDA UDI	Class II	Active
Drgem	GXR-EC25	FDA UDI	Class I	Active
Drgem	SGXR-C52SD	FDA UDI	Class II	Active
Drgem	SGXR-32S	FDA UDI	Class II	Active
GXR-ES, ECS Diagnostic X-ray System	GXR-E20S	FDA UDI	Class II	Active
Drgem	FDR Smart FGXR-32S	EUDAMEDFDA UDI	Class II	Active
Drgem	SGXR-C32S	FDA UDI	Class II	Active
Drgem	GXR-C40	FDA UDI	Class I	Active
FDR Clinica	FDR Clinica FGXR-C32S	FDA UDI	Class II	Active
Drgem	SGXR-C32S	FDA UDI	Class II	Active
Drgem	SGXR-U40SD	FDA UDI	Class II	Active
RAYMO Mobile X-ray System (Model: RAYMO)	K260085	FDA 510(k)	Class II	Active
Drgem	FDR Smart FGXR-U40S	EUDAMEDFDA UDI	Class II	Active

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