Manufacturer registered with FDA
Surgicon Pvt Ltd
Sialkot, Pakistan. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 104,514 registrations outside the US
- Establishments
- 1Pakistan
Registered in 10 markets
Where regulators' registries name Surgicon 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 | Surgicon Pvt Ltd | 4 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | SURGICON (PVT) LTD | 3,071 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Surgicon Private LimitedSURGICON AG | 1,376 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Surgicon(PVT) Ltd.Surgicon (PVT) Ltd. · SURGICON(Pvt) Ltd., · +2 | 51 | 2000–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SURGICON (PVT) LIMITEDSURGICON (PVT) LTD · SURGICON PVT. LTD | 10 | 2005–2020 | Pure Global AI |
| Canada | Health Canada | Registration holder | SURGICON, INC. | 2 | 2003–2003 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SURGICON (PVT) LTD | 1 | 2024–2024 | Pure Global AI |
| China | NMPA | Registration holder | 赛克医疗股份有限公司SURGICON AG | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SURGICON (PVT) LIMITED | 1 | 2022–2022 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | SURGICON AG | 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 Surgicon 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 |
|---|---|---|---|---|
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | PROBE, PERIODONTIC | 2017 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | 2017 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | ELEVATOR, SURGICAL, DENTAL | 2017 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | SCALER, PERIODONTIC | 2017 |
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 |
|---|---|---|
| SURGICON PVT LTDFDA reg. 3007597038 | Sialkot Punjab, Pakistan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045942). 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.