Manufacturer registered with FDA
Mapaex Health And Personalcare Ireland Private Limited
Newbridge, Ireland. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 237 registrations outside the US
- Establishments
- 1Ireland
Registered in 2 markets
Where regulators' registries name Mapaex Health And Personalcare Ireland Private Limited 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 | Mapaex Health And Personalcare Ireland Private Limited | 3 device types | — | Below |
| Colombia | INVIMA | Manufacturer | MAPAEX HEALTH AND PERSONAL CARE IRELAND PRIVATE LIMITEDMAPAEX HEALTH AND PERSONALCARE IRELAND PRIVATE LIMITED | 37 | — | 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 Mapaex Health And Personalcare Ireland Private Limited 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 | OB ADV 3DW FRESH 35S 1CT MEA FPCOK001 OB BABWIN 0-2YR XS 1CT MEA FPCOK003 OBKIDS CRSFRZ 3+Y S 1CT MEA FPCOK011 OBKIDS STRWRS 6+Y S 1CT MEA FPCOM009 OB Pro Exp AIO Med 40 MEA FPCOM066 OB PULS 3DW WTNG 35S 1CT MEA FPCOM066 OB PULS DPCL 35M 1CT MEA FPCOM132 OB CLS3Eff 40M 3ct MEA FPCOral B Pro Health Clinical Pro Flex. | 2022 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Oral-B Charcoal Electric Toothbrush Replacement Brush Heads Refill. | 2022 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | GlideMultiprotection Ariel II-Floss | 2022 |
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 |
|---|---|---|
| MAPAEX HEALTH AND PERSONALCARE IRELAND PRIVATE LIMITEDFDA reg. 3023222182 | Newbridge Kildare, Ireland | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10085384). 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.