FDA Registration
Active
🇺🇸 United States
HEALTH BEACONS, INC.
Reg #: 3013649990
·
FEI: 3013649990
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HEALTH BEACONS, INC.
- Registration Number
- 3013649990
- FEI Number
- 3013649990
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 250 Campus Drive
- City
- Marlborough
- State
- MA
- ZIP
- 01752
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181692
Owner / Operator
- Firm Name
- HOLOGIC, INC.
- Operator Number
- 9007676
- Address
- 250 Campus Drive, --
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
- Correspondent
- Sue Dahlquist
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2025-12-08 |
Proprietary Names
LOCalizer
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility