Data / Medical devices / Hungary / MAM Hungária Kft.
MAM Hungária Kft.: FDA-registered device maker in Vaskeresztes, Hungary, 1 510(k) clearance
MAM Hungária Kft. is registered with the FDA (registration 3008478778) in Vaskeresztes, Hungary. It lists 7 device types. The FDA files 1 510(k) clearance 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
- 3008478778
- Address
- Fö ut 132, Vaskeresztes, Hungary, 9795
- Owner or operator
- MAM Baby AG (9054867)
- Roles
- Manufacturer
- First device listed
- January 27, 2003
- Registered through
- 2026
- Brand names listed
- Baby's Brush with Safety Shield, 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, MAM Manual Breast Pump and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nipple, Lambs Feeding | FNN | 1 | Manufacturer | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Manufacturer | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Nipple | HFS | 1 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Manufacturer | 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 |
Compare with other makers
- All makers of Nipple, Lambs Feeding
- All makers of Ring, Teething, Non-Fluid Filled
- All makers of Shield, Nipple
- All makers of Pump, Breast, Powered
- All makers of Toothbrush, Manual
- All makers of Pick, Massaging
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.