Manufacturer registered with FDA
Gesco Healthcare Private Limited
Chennai, India. Lists 17 dental device types with FDA across 1 registered establishment.
- Device types listed
- 17
- Brands and models
- 17
- 510(k) clearances
- 0as applicant
- Markets registered in
- 2216 registrations outside the US
- Establishments
- 1India
Registered in 2 markets
Where regulators' registries name Gesco Healthcare Private 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 | Gesco Healthcare Private Limited | 17 device types | — | Below |
| India | CDSCO | Registration holder | GESCO HEALTHCARE PRIVATE LIMITEDGesco Healthcare Private Limited | 216 | 2019–2026 | 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 Gesco Healthcare Private Limited currently lists, by FDA device type, with the brand and model names on the listing.
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 |
|---|---|---|
| Gesco Healthcare Private LimitedFDA reg. 9613926 | CHENNAI, Tamil Nadu, India | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9032080). 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.