FDA Registration
Active
🇺🇸 United States
ADVAMEDICA INC.
Reg #: 3017391151
·
FEI: 3017391151
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- ADVAMEDICA INC.
- Registration Number
- 3017391151
- FEI Number
- 3017391151
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Harvard Square, 1 Mifflin place, Suite 400
- City
- Cambridge
- State
- MA
- ZIP
- 02138
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213198
Owner / Operator
- Firm Name
- ADVAMEDICA INC.
- Operator Number
- 10077783
- Address
- Harvard Square, 1 Mifflin place, Suite 400
- City
- Cambridge
- State
- MA
- Postal Code
- 02138
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Temporary, Internal Use Hemostatic | POD | Class 2 | General, Plastic Surgery | No | 2023-05-09 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2024-01-04 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2023-05-08 |
Proprietary Names
Ax-Surgi
Maxiocel Chitosan Wound Dressing
Axiostat Gauze
AXIOSTAT PATCH
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198