Manufacturer registered with FDA
Medimaging Integrated Solution Inc.
Hsinchu, Taiwan. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 836 registrations outside the US
- Establishments
- 1Taiwan
Registered in 8 markets
Where regulators' registries name Medimaging Integrated Solution Inc. 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 | Medimaging Integrated Solution Inc. | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Medimaging Integrated Solution Inc | 12 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Medimaging Integrated Solution Inc. | 8 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Medimaging Integrated Solution Inc.Medimaging Integrated Solution, Inc. · MEDIMAGING INTEGRATED SOLUTION, INC. · +1 | 6 | 2013–2025 | Pure Global AI |
| Japan | PMDA | Registration holder | Ｍｅｄｉｍａｇｉｎｇ Ｉｎｔｅｇｒａｔｅｄ Ｓｏｌｕｔｉｏｎ Ｉｎｃ． | 4 | 2022–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Medimaging Integrated Solution Inc | 3 | 2019–2024 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MEDIMAGING INTEGRATED SOLUTION INC | 2 | 2025–2025 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Medimaging Integrated Solution Inc. | 1 | 2026–2026 | 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 Medimaging Integrated Solution Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | — | 2017 |
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 |
|---|---|---|
| MEDIMAGING INTEGRATED SOLUTION INC.FDA reg. 3015316279 | Hsinchu Hsinchu(City), Taiwan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10037829). 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.