FDA Registration
Active
🇨🇭 Switzerland
MAM Baby AG
Reg #: 3016245319
·
FEI: 3016245319
·
Expires 2026
Products
8
Proprietary Names
18
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- MAM Baby AG
- Registration Number
- 3016245319
- FEI Number
- 3016245319
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Sihleggstrasse 15
- City
- Wollerau Schwyz
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K193449
Owner / Operator
- Firm Name
- MAM Baby AG
- Operator Number
- 9054867
- Address
- Sihleggstrasse 15
- City
- Wollerau
- State
- Schwyz
- Postal Code
- 8832
- Country
- CH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2020-09-23 |
| Ring, Teething, Fluid-Filled | KKO | Class 2 | Dental | No | 2010-12-17 |
| Nipple, Lambs Feeding | FNN | Class 1 | General Hospital | No | 2017-05-09 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2009-07-23 |
| Ring, Teething, Non-Fluid Filled | MEF | Class 1 | Dental | No | 2009-07-23 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2003-01-27 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2019-07-22 |
| Shield, Nipple | HFS | Class 1 | General Hospital | No | 2019-03-11 |
Proprietary Names
Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
MAM Twister
Preemie 1
MAM Comfort size 1
Preemie 2
MAM Perfect Pacifier
MAM Comfort size 2
Massaging Brush
Bite & Relax
MAM Cooler, Mini Cooler, Bite & Play
Bite & Brush
Starter
Training Brush
First Brush
Baby's Brush with Safety Shield
MAM Manual Breast Pump
Oral Care Rabbit
MAM Nipple shield size 1 and 2
Establishment Types
Export Device to the United States But Perform No Other Operation on Device