FDA Registration
Active
🇺🇸 United States
Catheter for Use with Urodynamics System
Reg #: 1223490
·
FEI: 1000136543
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- COGENTIX MEDICAL, INC.
- Registration Number
- 1223490
- FEI Number
- 1000136543
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 135 Flanders Rd
- City
- Westborough
- State
- MA
- ZIP
- 01581
- Country
- US
Owner / Operator
- Firm Name
- COGENTIX MEDICAL, INC.
- Operator Number
- 9006902
- Address
- 135 Flanders Road, --
- City
- Westborough
- State
- MA
- Postal Code
- 01581
- Country
- US
- Correspondent
- Nicole - Boser
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2018-12-10 |
Proprietary Names
Catheter for Use with Urodynamics System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)