Manufacturer registered with FDA
Medihub Co., Ltd.
Gunpo-si, South Korea. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 46 registrations outside the US
- Establishments
- 1South Korea
Registered in 4 markets
Where regulators' registries name Medihub 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 | Medihub Co., Ltd. | 3 device types | — | Below |
| Israel | AMAR | Manufacturer | Medihub Co.,Ltd. | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MEDIHUB CO., LTD. | 2 | 2020–2024 | Pure Global AI |
| Japan | PMDA | Registration holder | Ｍｅｄｉｈｕｂ Ｃｏ．， Ｌｔｄ． | 1 | 2024–2024 | 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 Medihub 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 |
|---|---|---|---|---|
| Anesthetic Tube WarmerEFC · Class 1 | — | Maker | i-JECT BTS Warmeri-JECT ON | 2021 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | I-JECT Bi-JECT BTS injectorI-JECT MDi-JECT ST | 2021 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | DSA Kit (Crestal approach Kit) | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MEDIHUB CO., LTD.FDA reg. 3018077478 | Gunpo-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10080823). 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.