Manufacturer registered with FDA
SunMed Group Holdings, LLC dba AirLife
Grand Rapids, MI, United States. Lists 2 dental device types with FDA across 2 registered establishments.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 411 registrations outside the US
- Establishments
- 2Mexico, United States
Registered in 4 markets
Where regulators' registries name SunMed Group Holdings, LLC dba AirLife 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 | SunMed Group Holdings, LLC dba AirLife | 2 device types | — | Below |
| Israel | AMAR | Manufacturer | SunMed Group Holdings, LLC dba AirLife | 7 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SunMed Group Holdings, LLC dba AirLife | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Westmed de Mexico, S.A. de C.VWestmed de Mexico. S.A de C.V | 2 | 2017–2018 | 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 SunMed Group Holdings, LLC dba AirLife currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | TOOTHBRUSH, MANUAL | 2024 |
| Patient Personal Hygiene KitNSB · Class 1 | — | Maker | Patient personal hygiene kit | 2024 |
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 |
|---|---|---|
| SunMed Group Holdings, LLCFDA reg. 1314417 | Grand Rapids, MI, United States | Complaint file establishment, Specification developer |
| Westmed de Mexico, S.A de C.VFDA reg. 8030647 | MAGDALENA Sonora, Mexico | Contract manufacturer |
Other names on FDA records
Westmed de Mexico. S.A de C.V · SunMed Group Holdings, LLC
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10044795). 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.