Manufacturer registered with FDA
Jai Surgicals Limited
GURGAON, HARYANA, India. 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
- 824 registrations outside the US
- Establishments
- 1India
Registered in 8 markets
Where regulators' registries name Jai Surgicals 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 | Jai Surgicals Limited | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Jai Surgicals Limited | 6 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Jai Surgicals Limited | 6 | — | Pure Global AI |
| India | CDSCO | Registration holder | JAI SURGICALS LIMITED | 5 | 2023–2023 | Pure Global AI |
| South Korea | MFDS | Manufacturer | (주)아이리^JAI SURGICALS LIMITEDJAI SURGICALS LIMITED | 3 | 2014–2023 | Pure Global AI |
| Canada | Health Canada | Registration holder | JAI SURGICALS LIMITED | 2 | 2005–2005 | Pure Global AI |
| Australia | TGA | Manufacturer | Jai Surgicals Limited | 1 | 2005–2005 | Pure Global AI |
| Israel | AMAR | Manufacturer | Jai Surgicals 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 Jai Surgicals 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 |
|---|---|---|---|---|
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | — | 2006 |
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 |
|---|---|---|
| JAI SURGICALS LTD.FDA reg. 8044030 | ALWAR Rajasthan, India | Contract manufacturer, Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9005214). 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.