Manufacturer registered with FDA
MAM Baby AG
Wollerau, Switzerland. Lists 4 dental device types with FDA across 3 registered establishments.
- Device types listed
- 4
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 3Switzerland, Hungary, Thailand
Registered in 3 markets
Where regulators' registries name MAM Baby AG 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 | MAM Baby AG | 4 device types | — | Below |
| Brazil | ANVISA | Manufacturer | MAM BABY AG. | 2 | 2025–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | MAM Baby AG | 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 MAM Baby AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Massaging BrushOral Care Rabbit | 2009 |
| Teething Ring Non-Fluid FilledMEF · Class 1 | — | Maker | Bite & BrushBite & RelaxStarter | 2009 |
| Fluid-Filled Teething RingKKO · Class 2 | — | Maker | MAM Cooler, Mini Cooler, Bite & PlayMAM Twister | 2010 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Baby's Brush with Safety ShieldFirst BrushTraining Brush | 2003 |
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
MAM Baby AG 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: Mam International AG (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Jul 2010 | K093266 | MAM COOLER | Mam International AG | KKO Fluid-Filled Teething Ring |
| 23 Jun 2010 | K092781 | MAM TWISTER | Mam International AG | KKO Fluid-Filled Teething Ring |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MAM Baby AGFDA reg. 3016245319 | Wollerau Schwyz, Switzerland | Foreign exporter |
| MAM Hungária Kft.FDA reg. 3008478778 | Vaskeresztes, Hungary | Manufacturer |
| Thaimed Hightech Co.,Ltd.FDA reg. 3012134276 | Kabinburi Prachin Buri, Thailand | Manufacturer |
Other names on FDA records
Thaimed Hightech Co.,Ltd. · MAM Hungária Kft.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9054867). 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.