Manufacturer registered with FDA
Suru International Pvt Ltd
Mumbai, 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
- 15331 registrations outside the US
- Establishments
- 1India
Registered in 15 markets
Where regulators' registries name Suru International 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 | Suru International Pvt Ltd | 1 device types | — | Below |
| India | CDSCO | Registration holder | SURU INTERNATIONAL PVT LTD | 217 | 2020–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SURU INTERNATIONAL PVT. LTDSURU INTERNATIONAL PVT. LTD. · SURU INTERNATIONAL PVT LTD | 27 | 2007–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SURU INTERNATIONAL PRIVATE LIMITEDSURU INTERNATIONAL PVT. LTD · SURU INTERNATIONAL PVT. LTD. | 20 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | SURU INTERNATIONAL PVT LTD | 17 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | SURU International Pvt. Limited | 12 | 2024–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SURU INTERNATIONAL PVT. LTD.SURU INTERNATIONAL PVT LTD | 11 | 2010–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | SURU INTERNATIONAL PVT. LTD. | 8 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Suru International PVT. LTD.SURU INTERNATIONAL PVT LTD. · SURU International Pvt. Limited · +1 | 5 | — | Pure Global AI |
| Philippines | FDA Philippines | Manufacturer | SURU International Pvt., Limited | 4 | 2025–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | SURU International Pvt Ltd. | 4 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | SURU INTERNATIONAL PVT. LTD., | 3 | 2025–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Suru International Pvt Ltd | 1 | 2021–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | SURU International Pvt, Ltd. | 1 | 2008–2008 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | SURU INTERNATIONAL PVT. LTD. | 1 | 2023–2023 | 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 Suru International 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 |
|---|---|---|---|---|
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | SURU | 2025 |
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 |
|---|---|---|
| SURU INTERNATIONAL PVT LTDFDA reg. 3007092328 | DAHANU Maharashtra, India | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091867). 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.