Manufacturer registered with FDA
Meditec Devices
VASAI EAST,DISTRICT PALGHAR, India. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 566 registrations outside the US
- Establishments
- 1India
Registered in 5 markets
Where regulators' registries name Meditec Devices 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 | Meditec Devices | 1 device types | — | Below |
| India | CDSCO | Registration holder | Meditec Devices | 56 | 2021–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MEDITEC DEVICES | 6 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Meditec Devices | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MEDITEC DEVICES | 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 Meditec Devices 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 | Gynex Keye's PunchTru-Punch-Sklar | 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 |
|---|---|---|
| MEDITEC DEVICESFDA reg. 3006389770 | VASAI(E), THANE, MAHARASHTRA, India | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9096299). 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.