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GENORAY CO., LTD.

South Korea·KR-MF-000021014

Last updated September 17, 2026

Information

Country: South Korea
Address: 60, Dunchon-daero 541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, South Korea
Website: genoray.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Seogkyu Kim
EUDAMED SRN: KR-MF-000021014
FDA FEI Number: 3005843418
DUNS Number: 631064672

Catalogue (67)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
ZEN-PX4e	207	EUDAMED	Class IIb	Active
PORT-X IVe	207	EUDAMED	Class IIb	Active
Genoray	PAPAYA 3D Premium Plus	FDA UDI	Class II	Active
Genoray	PORT-XII	FDA UDI	Class II	Active
Genoray	PAPAYA 3D Plus	FDA UDI	Class II	Active
Genoray	ZEN-7000	FDA UDI	Class II	Active
Genoray	PAPAYA 3D	FDA UDI	Class II	Active
Genoray	SUNI Pan Q	FDA UDI	Class II	Active
Genoray	PAPAYA Plus	FDA UDI	Class II	Active
Genoray	PAPAYA 3D Premium	FDA UDI	Class II	Active
Genoray	VOLUX 21C	FDA UDI	Class II	Active
Genoray	GenX-CR	FDA UDI	Class II	Active
Genoray	Zenis	FDA UDI	Class II	Active
Genoray	PAPAYA	FDA UDI	Class II	Active
Genoray	SUNI Pan Q-C	FDA UDI	Class II	Active
Genoray	ZEN-PX4	EUDAMEDFDA UDI	Class II	Active
Genoray	VOLUX 21	FDA UDI	Class II	Active
Genoray	Triana	FDA UDI	Class II	Active
Genoray	VOLUX	FDA UDI	Class II	Active
Genoray	Suni Q-C3D	FDA UDI	Class II	Active
Genoray	OSCAR 15	FDA UDI	Class II	Active
Genoray	Suni Q3D	FDA UDI	Class II	Active
Genoray	ZEN-2090 Turbo	FDA UDI	Class II	Active
Sc15	A02	EUDAMED	Class IIb	Active
Papaya Plus, Digital Extraoral Source X-Ray System	K130419	FDA 510(k)	Class II	Active
OSCAR (OSCAR Prime, OSCAR Classic)	K181943	FDA 510(k)	Class II	Active
Portable X-Ray System, Model Port-X Ii	K063121	FDA 510(k)	Class II	Active
Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro	K091918	FDA 510(k)	Class II	Active
Port-X Iv	K172810	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Volux, Digital Extraoral Source X-Ray System	K092171	FDA 510(k)	Class II	Active
Volux 21c, Digital Extraoral Source X-Ray System	K120263	FDA 510(k)	Class II	Active
Oscar 15 & Oscar 15i	K230787	FDA 510(k)	Class II	Active
GenX-CR	K232158	FDA 510(k)	Class II	Active
Port View, Digital X-Ray Sensor System	K130088	FDA 510(k)	Class II	Active
Dvas (dvas-M, Dvas-W)	K232085	FDA 510(k)	Class II	Active
Zen-7000, System, Fluroscopic X-Ray System	K140041	FDA 510(k)	Class II	Active
Gt300; Gt300-C	K250060	FDA 510(k)	Class II	Active
Triana, Picture Archiving And Communications System	K103182	FDA 510(k)	Class II	Active
Zenis, Picture Archiving And Communications System	K103181	FDA 510(k)	Class II	Active
Papaya Plus, Digital Extraoral Source X-Ray System	K141700	FDA 510(k)	Class II	Active
OSCAR 15iL	A01	EUDAMED	Class IIb	Active
Xeno-360	111	EUDAMED	Class IIb	Active
OSCAR 15(Unique FD)	107	EUDAMEDFDA UDI	Class IIb	Active
Mx-600	503	EUDAMED	Class IIb	Active
PortView(GIX-1)	603	EUDAMEDFDA UDI	Class IIa	Active
Opescope Acteno Fd15	A02	EUDAMED	Class IIb	Active
Dmx-600	506	EUDAMED	Class IIb	Active
PAPAYA Plus(GDP-1C, VOLUX 29)	404	EUDAMEDFDA UDI	Class IIb	Active
PAPAYA 3D Plus (VOLUX 55)	704	EUDAMEDFDA UDI	Class IIb	Active
OSCAR Classic(Unique Class)	109	EUDAMEDFDA UDI	Class IIb	Active

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