FDA Registration
Active
🇮🇳 India
FORUS HEALTH PVT.LTD.,
Reg #: 3012162565
·
FEI: 3012162565
·
Expires 2026
Products
6
Proprietary Names
15
Establishment Types
4
Classifications
6
Registration Details
- Registration Name
- FORUS HEALTH PVT.LTD.,
- Registration Number
- 3012162565
- FEI Number
- 3012162565
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 8, 27th Cross Rd, Banashankari Stage II, Banashankari
- City
- Bengaluru Karnataka
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K183059
Owner / Operator
- Firm Name
- FORUS HEALTH PVT.LTD.,
- Operator Number
- 10050919
- Address
- No. 8, 27th cross,, Banashankari 2nd stage
- City
- Bengaluru
- State
- Karnataka
- Postal Code
- 560070
- Country
- IN
US Agent
- Business Name
- Forus Health, Inc.
- Contact Name
- Donny Thomas
- Address
- 20116 Ashbrook PL Ste 130, Ashburn, VA 20147, Ashburn, VA
- City
- Ashburn
- State
- VA
- ZIP
- 20147
- Country
- US
- [email protected]
- Phone
- 703 7241646
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Photorefractor | MMF | Class 2 | Ophthalmic | No | 2026-05-13 |
| Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | PUE | Class 2 | Ophthalmic | No | 2025-06-10 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2019-01-14 |
| Camera, Ophthalmic, General-Use | PJZ | Class 2 | Ophthalmic | No | 2016-01-18 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2019-08-15 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 2024-04-18 |
Proprietary Names
G5 Vision Screener
3nethra SL5-1000
3nethra SL5-1000 Pro
3nethra neo
3nethra neo HD
3nethra neo HD FA
3nethra classic
3nethra classic HD
3nethra classic 6.4
3nethra classic+
3nethra pico
3nethra ultima
Ovitz xwave
3nethra aberro
3nethra specto
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device