FDA Registration
Active
🇺🇸 United States
Fiber Cystoscope, EndoSheath & Battery Light Source
Reg #: 2242464
·
FEI: 2242464
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- COGENTIX MEDICAL, INC.
- Registration Number
- 2242464
- FEI Number
- 2242464
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 40 Ramland Rd S
- City
- ORANGEBURG
- State
- NY
- ZIP
- 10962
- Country
- US
Regulatory Submissions
- 510(k) Number
- K071127
Owner / Operator
- Firm Name
- COGENTIX MEDICAL, INC.
- Operator Number
- 9105687
- Address
- 40 RAMLAND RD. SOUTH, --
- City
- Orangeburg
- State
- NY
- Postal Code
- 10962
- Country
- US
- Correspondent
- Nicole - Boser
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2007-12-03 |
Proprietary Names
Fiber Cystoscope, EndoSheath & Battery Light Source
CST-2000A Cystoscope/Hysteroscope
CST-4000/4000i Cystoscope/Hysteroscope
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device