Manufacturer registered with FDA
Auxein Medical Pvt Ltd
Sonipat, India. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 9520 registrations outside the US
- Establishments
- 1India
Registered in 9 markets
Where regulators' registries name Auxein Medical Pvt 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 | Auxein Medical Pvt Ltd | 1 device types | — | Below |
| India | CDSCO | Registration holder | Auxein Medical Private LimitedAuxeinMedical Pvt Ltd · Auxein Medical Pvt Ltd | 313 | 2015–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Auxein Medical Private Limited | 65 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | AUXEIN MEDICAL PRIVATE LIMITEDAUXEIN MEDICAL PVT. LTD. · AUXEIN MEDICAL Pvt. Ltd. | 47 | 2019–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Auxein Medical Private Limited | 35 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | AUXEIN MEDICAL PRIVATE LIMITEDAUXEIN MEDICAL PVT. LTD. · AUXEIN MEDICAL · +1 | 34 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | AUXEIN MEDICAL PVT. LTD | 17 | 2025–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Auxein Medical Private Limited | 8 | 2023–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Auxein medical Private limited | 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 Auxein Medical Pvt 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 |
|---|---|---|---|---|
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | AUXEIN MEDICAL PVT LTD | 2019 |
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 |
|---|---|---|
| Auxein medical Private limitedFDA reg. 3010303097 | Sonipat Haryana, India | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046810). 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.