Manufacturer registered with FDA
Sanctuary Health Sdn Bhd
Chemor, Malaysia. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 11130 registrations outside the US
- Establishments
- 1Malaysia
Registered in 11 markets
Where regulators' registries name Sanctuary Health 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 | Sanctuary Health Sdn Bhd | 7 device types | — | Below |
| Malaysia | MDA | Registration holder | SANCTUARY HEALTH SDN BHD | 42 | 2022–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Sanctuary Health Sdn Bhd | 24 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Sanctuary Health Sdn Bhd | 21 | 2014–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | SANCTUARY HEALTH SDN BHDSanctuary Health SDN BHD · SANCTUARY HEALTH SDN. BHD. · +2 | 11 | 2007–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SANCTUARY HEALTH SDN BHDSANCTUARY HEALTH SDN. BHD | 8 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SANCTUARY HEALTH SDN. BHDSANCTUARY HEALTH SDN. BHD. | 8 | 2017–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Sanctuary Health Sdn Bhd | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SANCTUARY HEALTH SDN BHD | 6 | 2011–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SANCTUARY HEALTH SDN. BHD.SANCTUARY HEALTH SDN BHD | 3 | 2017–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Sanctuary Health 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 Sanctuary Health 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 Dam ClampEEF · Class 1 | Rubber dam systems | Maker | — | 2023 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | — | 2005 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Sanctuary ComfiTract Latex- Free Cheek Retractor | 2025 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | — | 2023 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | — | 2023 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | — | 2023 |
| Dental Prophylaxis KitNYC · Class 1 | Dental hand instruments | Maker | Dental Dam Premium Kit | 2023 |
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 |
|---|---|---|
| SANCTUARY HEALTH SDN BHDFDA reg. 3005497907 | Chemor Perak, Malaysia | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9080281). 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.