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GNI Co., Ltd

South Korea·KR-MF-000031792

Last updated September 17, 2026

Information

Country: South Korea
Address: 5F 501, 63-12, Dongtancheomdansaneop 1-ro, Hwaseong-si, Gyeonggi-do, South Korea
Website: www.gniortho.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +82 70 4337 2613
PRRC Contact: Soo Woong Choi
EUDAMED SRN: KR-MF-000031792
FDA FEI Number: 3014270297
DUNS Number: 694828541

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Device	Model / Reference	Registries	Class	Status
Zar-18-053	ZAR-18-053	FDA UDI	Class I	Active
M1e-22-031	M1E-22-031	FDA UDI	Class I	Active
Sbn-E18-164g	SBN-E18-164G	FDA UDI	Class I	Active
Sbn-R18-171g	SBN-R18-171G	FDA UDI	Class I	Active
Sa1210c	SA1210C	FDA UDI	Class II	Active
M1m-22-051	M1M-22-051	FDA UDI	Class I	Active
Rcr-22-031	RCR-22-031	FDA UDI	Class II	Active
Var-22-301	VAR-22-301	FDA UDI	Class II	Active
Sbn-E18-261g	SBN-E18-261G	FDA UDI	Class I	Active
Rce-18-331	RCE-18-331	FDA UDI	Class II	Active
Rsm-22-551	RSM-22-551	FDA UDI	Class II	Active
Sbn-E22-171g	SBN-E22-171G	FDA UDI	Class I	Active
Rcm-22-503	RCM-22-503	FDA UDI	Class II	Active
Vpr-18-501	VPR-18-501	FDA UDI	Class II	Active
M1m-18-031	M1M-18-031	FDA UDI	Class I	Active
Ies1-1001	IES1-1001	FDA UDI	Class I	Active
Sbn-M22-374g	SBN-M22-374G	FDA UDI	Class I	Active
Rce-22-553	RCE-22-553	FDA UDI	Class II	Active
Rse-22-553	RSE-22-553	FDA UDI	Class II	Active
Sbn-M18-271g	SBN-M18-271G	FDA UDI	Class I	Active
Zam-22-551	ZAM-22-551	FDA UDI	Class I	Active
M1m-22-501	M1M-22-501	FDA UDI	Class I	Active
Rsm-22-301	RSM-22-301	FDA UDI	Class II	Active
ROSA Bracket	K182672	FDA 510(k)	Class II	Active
VENUS Bracket, ROSE Bracket	K201410	FDA 510(k)	Class II	Active
Orthodontic Fixation Screw [Smart Anchor Miniscrew]	K191041	EUDAMEDFDA 510(k)FDA UDI	Class II	Active

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