FDA Registration
Active
🇺🇸 United States
UNITY Video Processors
Reg #: 2242464
·
FEI: 2242464
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
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
- K181292
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 |
|---|---|---|---|---|---|
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2018-12-10 |
| Esophagoscope (Flexible Or Rigid) | EOX | Class 2 | Ear, Nose, Throat | No | 2018-12-10 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | OCS | Class 2 | Gastroenterology, Urology | No | 2018-12-10 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2018-12-10 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2018-12-10 |
Proprietary Names
UNITY Video Processors
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility