Registered with FDA
Transmedic Healthcare Sdn. Bhd.
Kuala Lumpur, 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
- 2352 registrations outside the US
- Establishments
- 1Malaysia
Registered in 2 markets
Where regulators' registries name Transmedic Healthcare 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 | Lister | Transmedic Healthcare Sdn. Bhd. | 1 device types | — | Below |
| Malaysia | MDA | Registration holder | TRANSMEDIC HEALTHCARE SDN BHD | 352 | 2021–2027 | 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 Transmedic Healthcare 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 |
|---|---|---|---|---|
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | — | 2025 |
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
Transmedic Healthcare Sdn. Bhd. 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: W&H Dentalwerk Buermoos GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 7 Feb 2001 | K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | EBW Handpiece and Cord Foot Controller |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TRANSMEDIC HEALTHCARE SDN BHDFDA reg. 3013767421 | Kuala Lumpur, Malaysia | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091473). 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.