Manufacturer registered with FDA
Goldstar Medical Instruments
Sialkot, Pakistan. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 723 registrations outside the US
- Establishments
- 1Pakistan
Registered in 7 markets
Where regulators' registries name Goldstar Medical Instruments 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 | Goldstar Medical Instruments | 2 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Goldstar Medical Instruments | 10 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GOLDSTAR MEDICAL INSTRUMENTS | 8 | 2010–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Goldstar Medical Instruments | 2 | 2023–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Goldstar Medical Instruments | 1 | 2025–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Goldstar Medical Instruments | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GOLDSTAR MEDICAL INSTRUMENTS | 1 | 2022–2022 | 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 Goldstar Medical Instruments currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | — | 2003 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | — | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Goldstar Medical Instruments lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Hu-Friedy Mfg Co., LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 6 Nov 2012 | K120659 | HU-FRIEDY DENTAL CARTRIDGE SYRINGE | Hu-Friedy Mfg Co., LLC | EJI Cartridge Syringe |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GOLDSTAR MEDICAL INSTRUMENTSFDA reg. 3000126234 | SIALKOT Punjab, Pakistan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9053992). 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.