Manufacturer

Drgem

South KoreaLegal entities : DRGEM Corporation

Markets : Netherlands · Poland · Türkiye · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 14 · class I, II · latest in 2026 · see on the FDA website

EU representative : Obelis s.a. (Belgium)

6 categories, 14 models including 14 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Multifunctional systems for direct digital radiology	Z11031101	DIAMOND-5A, DIAMOND-6A, DIAMOND-8A3 refs GXR-32SD, GXR-40SD, GXR-52SD, GXR-68SD, GXR-82SD, GXR-C32SD, GXR-C40SD, GXR-C52SD, GXR-U32SD, GXR-U40SD3 refs PROMO RAYMO TOPAZ-32D, TOPAZ-40D2 refs	IIb MDR	EUDAMED record Report an error
Multifunctional systems for traditional radiology	Z110310	DIAMOND-5B, DIAMOND-6B, DIAMOND-8B3 refs DXC-RML, DXC-RMH2 refs FDR Smart FGXR-32S GXR-32S, GXR-40S, GXR-52S, GXR-68S, GXR-82S, GXR-C32S, GXR-C40S, GXR-C52S, GXR-U32S, GXR-U40S3 refs FDR Smart FGXR-E20S GXR-E20S, GXR-E25S, GXR-E32S, GXR-E40S, GXR-E50S, GXR-EC20S, GXR-EC25S, GXR-EC32S, GXR-EC40S, GXR-EC50S3 refs JADE-32, JADE-402 refs	IIb MDR	EUDAMED record Report an error
High voltage X-ray generators	Z11039011	GXR-32, GXR-40, GXR-52, GXR-68, GXR-82, GXR-C32, GXR-C40, GXR-C52, GXR-U32, GXR-U40	IIb MDR	EUDAMED record Report an error
Picture archiving and communication systems	Z110603	GEMPACS	I MDR	EUDAMED record Report an error
Radiography video acquisition systems	Z11039021	ACQUIDR	IIa MDR	EUDAMED record Report an error
X-ray tube assembly	Z11039012	DXT-8M, DXT-10M, DXT-11M, DXT-12M, DXT-14U, DXT-15U, DXT-17U, DXT-19U, DXT-8L, DXT-11L, DXT-13L3 refs	IIb 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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