FDA Registration
Active
🇺🇸 United States
Tibbe EUD
Reg #: 3035366119
·
FEI: 3035366119
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- SBE MEDICAL INC.
- Registration Number
- 3035366119
- FEI Number
- 3035366119
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 320 Dodge Rd NE, Suite B
- City
- Comstock Park
- State
- MI
- ZIP
- 49321
- Country
- US
Owner / Operator
- Firm Name
- SBE Medical Inc.
- Operator Number
- 10092519
- Address
- 320 Dodge Rd NE, Suite B
- City
- Comstock Park
- State
- MI
- Postal Code
- 49321
- Country
- US
- Correspondent
- Dan Byers
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Paste-On For Incontinence, Non-Sterile | NOA | Class 1 | Gastroenterology, Urology | No | 2025-01-23 |
Proprietary Names
Tibbe EUD
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device