FDA Registration
Active
🇺🇸 United States
GEL4MED, INC.
Reg #: 3016504086
·
FEI: 3016504086
·
Expires 2026
Products
1
Proprietary Names
4
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- GEL4MED, INC.
- Registration Number
- 3016504086
- FEI Number
- 3016504086
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 110 Canal St, 2nd floor
- City
- Lowell
- State
- MA
- ZIP
- 01852
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222025
Owner / Operator
- Firm Name
- Gel4Med, INC.
- Operator Number
- 10089559
- Address
- 1660 Soldiers Field Rd, STE 7
- City
- Brighton
- State
- MA
- Postal Code
- 02135
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2023-12-18 |
Proprietary Names
G4Derm / G4Derm Plus Synthetic Wound Matrix
G4Derm Plus
RV-X1
Suprello
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device