FDA Registration
Active
🇺🇸 United States
AMVAYA HOLDINGS, INC
Reg #: 3039243252
·
FEI: 3039243252
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- AMVAYA HOLDINGS, INC
- Registration Number
- 3039243252
- FEI Number
- 3039243252
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 265 Thimble Island Rd
- City
- Branford
- State
- CT
- ZIP
- 06405
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230133
Owner / Operator
- Firm Name
- Amvaya Holdings, Inc
- Operator Number
- 10093851
- Address
- 265 Thimble Island Rd.
- City
- Branford
- State
- CT
- Postal Code
- 06405
- Country
- US
- Correspondent
- Andrew Rapkin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss | QFQ | Class 2 | Gastroenterology, Urology | No | 2025-08-01 |
Proprietary Names
Plenity
Establishment Types
Complaint File Establishment per 21 CFR 820.198