Manufacturer registered with FDA
GeoMedi Co., Ltd.
Uiwang-si, South Korea. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 13
- 510(k) clearances
- 12025–2025
- Markets registered in
- 4123 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name GeoMedi Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | GeoMedi Co., Ltd. | 1 clearances | 2025–2025 | Below |
| European Union | EUDAMED | Manufacturer | GeoMedi Co., Ltd. | 113 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Geomedi Co., Ltd.GEOMEDI CO., LTD · GEOMEDI CO., LTD. | 6 | 2015–2021 | Pure Global AI |
| Australia | TGA | Manufacturer | GeoMedi Co Ltd | 4 | 2015–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What GeoMedi Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Geo AbutmentGeo CMFit AbutmentGeo Multibase AbutmentGeo ScrewMIST IC | 2021 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Geo 3D AnalogGeo ArcB ScanbodyGeo ArcB Scanbody AnalogGeo ArcB Scanbody KitGeo Impression Direct CopingGeo ScanbodyGeo Screw DriverGeo Torque Wrench | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
GeoMedi Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Imagine Milling Technologies, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Apr 2019 | K182246 | MIST IC | Imagine Milling Technologies, LLC | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GEOMEDI CO., LTD.FDA reg. 3017691835 | Uiwang-si, Gyeonggi, South Korea | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083327). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.