FDA Registration
Active
🇺🇸 United States
AION BIOSYSTEMS
Reg #: 3028019184
·
FEI: 3028019184
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AION BIOSYSTEMS
- Registration Number
- 3028019184
- FEI Number
- 3028019184
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 175 Cabot Street, Suite 100
- City
- Lowell
- State
- MA
- ZIP
- 01854
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250401
Owner / Operator
- Firm Name
- AION Biosystems
- Operator Number
- 10088613
- Address
- 175 Cabot Street
- City
- Lowell
- State
- MA
- Postal Code
- 01854
- Country
- US
- Correspondent
- Evi Paloumbis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-09-03 |
Proprietary Names
AION TempShield
iTempShield
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility