Skip to content

GNI Co., Ltd

South KoreaFDA applicant, unverified FDA FEI 3014270297

Devices
576
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI
Authorised rep.
CMC Medical Devices & Drugs SLES

What GNI Co., Ltd makes

GNI Co., Ltd manufactures orthodontic tubes, self-ligating orthodontic brackets, metal and ceramic orthodontic brackets, orthodontic archwires, orthodontic anchoring screws, reusable dental abrasive strips, and reusable surgical screwdrivers.

These devices are classified as Class I and Class II medical devices and are listed in the FDA UDI registry; the company is based in South Korea (KR).

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue576

Newest first, rows 1-50 of 576

Search and filter all 576 devices
Skip device list

  • M1E-18-301

    Listed Registry: GUDID Class:I

  • Var-22-501

    Active Regimes: 510(k) Registry: GUDID Class:II

  • SA1208C

    Listed Registry: GUDID Class:II

  • Rcr-18-503

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sbn-M22-2M44G

    Listed Registry: GUDID Class:I

  • ASE113-1l

    Listed Registry: GUDID Class:I

  • Var-18-331

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Zar-18-553

    Listed Registry: GUDID Class:I

  • Sbn-E18-2M41G

    Listed Registry: GUDID Class:I

  • Rsm-22-053

    Active Regimes: 510(k) Registry: GUDID Class:II

  • SA-020

    Listed Registry: GUDID Class:I

  • Zpm-22-503

    Listed Registry: GUDID Class:I

  • Sbc-R18-261g

    Listed Registry: GUDID Class:I

  • Var-18-553

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Rce-18-053

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Zpr-22-301

    Listed Registry: GUDID Class:I

  • Sbn-R18-371g

    Listed Registry: GUDID Class:I

  • M1M-22-553

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:I

  • Zam-22-053

    Listed Registry: GUDID Class:I

  • ASS423-3U

    Listed Registry: GUDID Class:I

  • Vpr-22-031

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sb-15HR

    Listed Registry: GUDID Class:I

  • Vam-18-331

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sbn-E18-464g

    Listed Registry: GUDID Class:I

  • M1E-22-503

    Listed Registry: GUDID Class:I

  • ASE123-2U

    Listed Registry: GUDID Class:I

  • M1R-22-031

    Listed Registry: GUDID Class:I

  • ASS413-3U

    Listed Registry: GUDID Class:I

  • M1R-22-331

    Listed Registry: GUDID Class:I

  • Sbn-M22-371g

    Listed Registry: GUDID Class:I

  • Sbn-R18-261g

    Listed Registry: GUDID Class:I

  • Sbc-E22-461g

    Listed Registry: GUDID Class:I

  • Rcm-18-503

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Vam-18-553

    Active Regimes: 510(k) Registry: GUDID Class:II

  • M1M-18-503

    Listed Registry: GUDID Class:I

  • Var-18-551

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Vam-18-501

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Zam-18-551

    Listed Registry: GUDID Class:I

  • SA1608

    Listed Registry: GUDID Class:II

  • SA1208

    Listed Registry: GUDID Class:II

  • Sb-90HR

    Listed Registry: GUDID Class:I

  • Sbc-M22-161g

    Listed Registry: GUDID Class:I

  • Sbn-M18-2M41G

    Listed Registry: GUDID Class:I

  • Rse-22-031

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Vam-22-551

    Active Regimes: 510(k) Registry: GUDID Class:II

  • M1E-18-031

    Listed Registry: GUDID Class:I

  • Sbn-E22-2M44G

    Listed Registry: GUDID Class:I

  • Rcm-18-501

    Active Regimes: 510(k) Registry: GUDID Class:II

  • ASE123-3l

    Listed Registry: GUDID Class:I

  • SA-002

    Listed Registry: GUDID Class:I

Rows 1-50 of 576

Showing 1-50 of 576

Company details

FDA FEI number
3014270297
DUNS number
694828541
Address
63-12, Dongtancheomdansaneop 1-ro 5F, 501, Hwaseong-si Gyeonggi

Frequently asked questions

How many devices does GNI Co., Ltd have in the registry?

The registry currently lists 576 devices for GNI Co., Ltd. Devices recorded under merged duplicate company entries are counted once.

Which registries list GNI Co., Ltd's devices?

Among its 50 most recently registered devices, GNI Co., Ltd has devices listed in EUDAMED (1 device) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do GNI Co., Ltd's devices fall under?

Among its 50 most recently registered devices, the classes recorded for GNI Co., Ltd's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from GNI Co., Ltd in the registry?

The most recently registered devices listed for GNI Co., Ltd include M1E-18-301, VAR-22-501, SA1208C and RCR-18-503.

Generated automatically from registry data and not verified by a human reviewer.