FDA Registration
Active
🇮🇱 Israel
VS3-Iridium System (VS3-IR)
Reg #: 9616637
·
FEI: 3003143838
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- VISIONSENSE, LTD.
- Registration Number
- 9616637
- FEI Number
- 3003143838
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 20 HAMAGSHIMIM ST.
- City
- Petach-Tikva Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K223020
Owner / Operator
- Firm Name
- VISIONSENSE, LTD.
- Operator Number
- 9042467
- Address
- HaMenofim 8 st, --
- City
- Herzliya
- State
- Central
- Postal Code
- 4612001
- Country
- IL
US Agent
- Business Name
- Covidien Llc
- Contact Name
- Chelsea Becker
- Address
- 161 Cheshire Lane, Suite 100
- City
- Plymouth
- State
- MN
- ZIP
- 55441
- Country
- US
- [email protected]
- Phone
- 763 6475571
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2022-11-10 |
Proprietary Names
VS3-Iridium System (VS3-IR)
Establishment Types
Manufacture Medical Device