FDA Registration
Active
🇺🇸 United States
Ameda, Inc.
Reg #: 3009974348
·
FEI: 3009974348
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Ameda, Inc.
- Registration Number
- 3009974348
- FEI Number
- 3009974348
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8206 Cross Park Dr
- City
- Austin
- State
- TX
- ZIP
- 78754
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250463
Owner / Operator
- Firm Name
- Ameda, Inc.
- Operator Number
- 10042362
- Address
- 8206 Cross Park Drive
- City
- Austin
- State
- TX
- Postal Code
- 78754
- Country
- US
- Correspondent
- Amy Pieper
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2025-04-29 |
| Bottle, Hot/Cold Water | FPF | Class 1 | General Hospital | No | 2016-12-16 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2012-11-19 |
| Shield, Nipple | HFS | Class 1 | General Hospital | No | 2015-03-27 |
Proprietary Names
GLO Wearable Breast Pump
Bottle, Hot/Cold Water
Manual Breast Pump
HygieniKit Milk Collection System
Mya Joy Plus Breast Pump
Elite Breast Pump
Pearl Breast Pump
Platinum Breast Pump
Nipple Shield
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility