FDA Registration
Active
🇬🇧 United Kingdom
OvuSense Fertility Monitor
Reg #: 3006799946
·
FEI: 3006799946
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- viO HealthTech Limited
- Registration Number
- 3006799946
- FEI Number
- 3006799946
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 211, Basepoint Business Centre, 377-399 London Road
- City
- Camberley Surrey
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K122337
Owner / Operator
- Firm Name
- viO HealthTech Limited
- Operator Number
- 10023236
- Address
- Unit 211, Basepoint Business Centre, 377-399 London Road
- City
- Camberley
- State
- Surrey
- Postal Code
- GU15 3HL
- Country
- GB
US Agent
- Business Name
- viO HealthTech Inc
- Contact Name
- Craig Citron
- Address
- 79 Cypress Road
- City
- Old Saybrook
- State
- CT
- ZIP
- 06475
- Country
- US
- [email protected]
- Phone
- 203 6400268
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Fertility Diagnostic, Proceptive | LHD | Class U | Unknown | No | 2013-10-28 |
Proprietary Names
OvuSense Fertility Monitor
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility