Manufacturer registered with FDA
Skanray Technologies Limited
Mysore, India. Lists 1 dental device type with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 5
- 510(k) clearances
- 32011–2017
- Markets registered in
- 6125 registrations outside the US
- Establishments
- 1India
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Skanray Technologies Limited 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 | Skanray Technologies Limited | 3 clearances | 2011–2017 | Below |
| European Union | EUDAMED | Manufacturer | SKANRAY TECHNOLOGIES PRIVATE LIMITED | 76 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | SKANRAY TECHNOLOGIES LIMITED | 42 | 2013–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SKANRAY TECHNOLOGIES PRIVATE LIMITEDSkanray Technologies Pvt. Ltd. | 3 | — | Pure Global AI |
| India | CDSCO | Registration holder | SKANRAY TECHNOLOGIES LIMITED | 3 | 2025–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Skanray Technologies Private Limited | 1 | 2015–2015 | 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 Skanray Technologies Limited 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 | IMAGESCAN HDINTRA SKAN DCINTRASKAN DCINTRASKAN DC PLUSXZeal Z70 DC | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Skanray Technologies Limited as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SKANRAY TECHNOLOGIES LIMITEDFDA reg. 3009001657 | Mysore Karnataka, India | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10036010). 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.