Manufacturer registered with FDA
Poskom Co Ltd
Goyang-si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1030 registrations outside the US
- Establishments
- 1South Korea
Registered in 10 markets
Where regulators' registries name Poskom 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 | Poskom Co Ltd | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | POSKOM CO., LTD.POSKOM. CO., LTD. | 12 | 2007–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | POSKOM Co., Ltd. | 8 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Poskom Co Ltd | 2 | 2009–2015 | Pure Global AI |
| Japan | PMDA | Registration holder | ＰＯＳＫＯＭ ＣＯ．， ＬＴＤ． | 2 | 2016–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | POSKOM Co., Ltd. | 2 | 2024–2024 | Pure Global AI |
| China | NMPA | Registration holder | 波思科Poskom co.,Ltd | 1 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | POSKOM CO.,LTD. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | POSKOM CO., LTD | 1 | 2023–2023 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Poskom Co.,Ltd. | 1 | — | 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 Poskom 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 |
|---|---|---|---|---|
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | REXTAR XXcam | 2013 |
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
Poskom 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: Meta Biomed Co, Ltd (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Jul 2013 | K132041 | REXTAR X | Meta Biomed Co, Ltd | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| POSKOM CO., LTDFDA reg. 3005246977 | Goyang-si Gyeonggi, South Korea | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9053091). 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.