Data / Medical devices / Switzerland / MAM Baby AG
MAM Baby AG: FDA-registered device maker in Wollerau Schwyz, Switzerland, 3 510(k) clearances
MAM Baby AG is registered with the FDA (registration 3016245319) in Wollerau Schwyz, Switzerland. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 11, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016245319
- Address
- Sihleggstrasse 15, Wollerau Schwyz, Switzerland, 8832
- Owner or operator
- MAM Baby AG (9054867)
- Roles
- Exporter to the US
- First device listed
- January 27, 2003
- Registered through
- 2026
- Brand names listed
- Baby's Brush with Safety Shield, Bite & Brush, Bite & Relax, Easy Manual Breast Pump, Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01), First Brush, MAM Comfort size 1, MAM Comfort size 2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nipple, Lambs Feeding | FNN | 1 | Exporter to the US | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Exporter to the US | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Exporter to the US | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Exporter to the US | accessdata.fda.gov |
| Ring, Teething, Fluid-Filled | KKO | 2 | Exporter to the US | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Exporter to the US | accessdata.fda.gov |
| Shield, Nipple | HFS | 1 | Exporter to the US | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2020 | K193449 | Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) | HGX | Substantially Equivalent | Guangdong Horigen Mother & Baby Products Co., Ltd. | accessdata.fda.gov |
| July 27, 2010 | K093266 | MAM COOLER | KKO | Substantially Equivalent | Mam International AG | accessdata.fda.gov |
| June 23, 2010 | K092781 | MAM TWISTER | KKO | Substantially Equivalent | Mam International AG | accessdata.fda.gov |
Compare with other makers
- All makers of Ring, Teething, Fluid-Filled
- All makers of Pick, Massaging
- All makers of Ring, Teething, Non-Fluid Filled
- All makers of Nipple, Lambs Feeding
- All makers of Pump, Breast, Powered
- All makers of Pump, Breast, Non-Powered
Updated September 11, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.