FDA Registration
Active
🇺🇸 United States
COGENTIX MEDICAL, INC.
Reg #: 2242464
·
FEI: 2242464
·
Expires 2026
Products
12
Proprietary Names
10
Establishment Types
4
Classifications
12
Registration Details
- Registration Name
- COGENTIX MEDICAL, INC.
- Registration Number
- 2242464
- FEI Number
- 2242464
- Status
- Active
- Expiry Year
- 2026
- 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 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | OCS | Class 2 | Gastroenterology, Urology | No | 2018-12-10 |
| Esophagoscope (Flexible Or Rigid) | EOX | Class 2 | Ear, Nose, Throat | 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 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2012-11-19 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2008-01-14 |
| Image, Illumination, Fiberoptic, For Endoscope | FFS | Class 2 | Gastroenterology, Urology | No | 2008-01-14 |
| Camera, Cine, Endoscopic, Without Audio | FWL | Class 1 | General, Plastic Surgery | No | 2007-08-10 |
| Laryngostroboscope | EQL | Class 1 | Ear, Nose, Throat | No | 2008-07-17 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2007-12-03 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2020-12-15 |
Proprietary Names
UNITY Video Processors
Stryker Video Ureteroscope
Digital Cystoscope and EndoSheath
CST-5000 Videocystoscope
DVC-2010 DIGITAL VIDEO CAMERA
STR-5000 Stroboscopy Unit
Fiber Cystoscope, EndoSheath & Battery Light Source
CST-2000A Cystoscope/Hysteroscope
CST-4000/4000i Cystoscope/Hysteroscope
BLS-1000 Battery Powered Light Source
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device