Manufacturer registered with FDA
Scope Medical Devices Private Limited
Ambala City, India. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 625 registrations outside the US
- Establishments
- 1India
Registered in 6 markets
Where regulators' registries name Scope Medical Devices 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 | Scope Medical Devices Private Limited | 2 device types | — | Below |
| Colombia | INVIMA | Manufacturer | SCOPE MEDICAL DEVICES PRIVATE LIMITED | 18 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Scope Medical Devices Pvt Ltd | 2 | 2018–2018 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SCOPE MEDICAL DEVICES PVT. LTD. | 2 | 2018–2022 | Pure Global AI |
| India | CDSCO | Registration holder | Scope Medical Devices Private Limited | 2 | 2022–2022 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SCOPE MEDICAL DEVICES Pvt. Ltd. | 1 | 2025–2025 | 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 Scope Medical Devices Private 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 |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | SCOPE | 2024 |
| Patient Personal Hygiene KitNSB · Class 1 | — | Maker | NSAMK-05NSMBPK-05 | 2026 |
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 |
|---|---|---|
| Scope Medical Devices Private LimitedFDA reg. 3006455037 | Ambala City Haryana, India | Manufacturer, Private-label distributor, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10024818). 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.