FDA Registration
Active
🇺🇸 United States
Chemo Mouthpiece
Reg #: 3005977121
·
FEI: 3005977121
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BihlerMed, LLC
- Registration Number
- 3005977121
- FEI Number
- 3005977121
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 85 INDUSTRIAL DRIVE
- City
- Phillipsburg
- State
- NJ
- ZIP
- 08865
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232917
Owner / Operator
- Firm Name
- BihlerMed, LLC
- Operator Number
- 9092868
- Address
- 85 Industrial Drive
- City
- Phillipsburg
- State
- NJ
- Postal Code
- 08865
- Country
- US
- Correspondent
- Eric Tarnowski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intraoral Cooling Device | QUA | Class 2 | Dental | No | 2024-03-18 |
Proprietary Names
Chemo Mouthpiece
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)