Manufacturer registered with FDA
Illuco Co, LTD
Gumpo-si, South Korea. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 714 registrations outside the US
- Establishments
- 1South Korea
Registered in 7 markets
Where regulators' registries name Illuco 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 | Illuco Co, LTD | 2 device types | — | Below |
| Australia | TGA | Manufacturer | Illuco Corporation Ltd | 5 | 2017–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ILLUCO CO. LTD. | 3 | 2023–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | ILLUCO Corporation Ltd. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | ILLUCO Corporation LTD.ILLUCO Corporation Ltd | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | ILLUCO Corporation Ltd. | 1 | 2025–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ILLUCO Corporation Ltd. | 1 | 2023–2023 | 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 Illuco 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | IDM-1C14-BIDM-1C14-DB | 2025 |
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | IHL-2000 | 2026 |
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 |
|---|---|---|
| ILLUCO CO, LTDFDA reg. 3023388535 | Gumpo-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088918). 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.