Manufacturer registered with FDA
TG Medical Sdn Bhd
KLANG, Malaysia. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 15679 registrations outside the US
- Establishments
- 1Malaysia
Registered in 15 markets
Where regulators' registries name TG Medical Sdn Bhd 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 | TG Medical Sdn Bhd | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | TG MEDICAL SDN BHDTG MEDICAL SDN. BHD. · TG MEDICAL SDN BHD. · +1 | 278 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | TG MEDICAL SDN. BHD. | 201 | 2004–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | TG Medical Sdn. Bhd.TG Medical Sdn. Bhd · TG MEDICAL SDN. BHD. · +2 | 47 | 2000–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | TG Medical Sdn BhdTG MEDICAL SDN. BHD. · TG MEDICAL SDN BHD · +2 | 37 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TG MEDICAL SDN. BHD.TG MEDICAL SDN, BHD, · TG MEDICAL SDN, BHD · +1 | 29 | 2005–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | TG MEDICAL SDN BHDTG MEDICAL SDN. BHD. · TG MEDICAL | 23 | 2010–2023 | Pure Global AI |
| Malaysia | MDA | Registration holder | TG MEDICAL SDN BHDTG MEDICAL SDN. BHD. | 18 | 2022–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | TG MEDICAL SDN BHDTG MEDICAL SDN,BHD | 13 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | TG MEDICAL SDN. BHD,TG MEDICAL SDN BHD, · TG Medical SDN.BHD, · +2 | 13 | 2022–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | TG MEDICAL SDN. BHD.TG MEDICAL SDN BHD · TG MEDICAL Sdn. Bhd | 8 | 2012–2022 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | TG MEDICAL SDN. BHD. | 7 | — | Pure Global AI |
| Australia | TGA | Manufacturer | TG Medical Sdn Bhd | 3 | 2004–2022 | Pure Global AI |
| China | NMPA | Registration holder | 顶级医疗私人有限公司TG MEDICAL SDN. BHD. | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | TG Medical Sdn. Bhd | 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 TG Medical Sdn Bhd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | — | 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 |
|---|---|---|
| TG MEDICAL SDN BHDFDA reg. 9680622 | KLANG Selangor, Malaysia | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9010202). 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.