FDA Registration
Active
🇮🇹 Italy
VISIA imaging S.r.l.
Reg #: 3007913988
·
FEI: 3007913988
·
Expires 2026
Products
9
Proprietary Names
17
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- VISIA imaging S.r.l.
- Registration Number
- 3007913988
- FEI Number
- 3007913988
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Martiri della Liberta, 95/e
- City
- San Giovanni Valdarno Arezzo
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K160327
Owner / Operator
- Firm Name
- VISIA imaging S.r.l.
- Operator Number
- 10030371
- Address
- Via Martiri della Liberta, 95/e
- City
- San Giovanni Valdarno
- State
- Arezzo
- Postal Code
- 52027
- Country
- IT
US Agent
- Business Name
- THEMA CORP
- Contact Name
- Silvia Tamarri
- Address
- 2929 Arch Street
- City
- Philadelphia
- State
- PA
- ZIP
- 19104
- Country
- US
- [email protected]
- Phone
- 215 8459459
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2016-06-21 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2018-07-10 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2021-11-08 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2011-10-28 |
| Device, Analysis, Anterior Segment | MXK | Class 2 | Ophthalmic | No | 2022-03-08 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2023-07-12 |
| Topographer, Corneal, Ac-Powered | MMQ | Class 1 | Ophthalmic | No | 2020-10-21 |
| Keratoscope, Ac-Powered | HLQ | Class 1 | Ophthalmic | No | 2009-09-24 |
| Perimeter, Automatic, Ac-Powered | HPT | Class 1 | Ophthalmic | No | 2021-07-05 |
Proprietary Names
ALADDIN HW3
MYAH
ALADDIN-M
SeeNA
ALADDIN TMS
i-Map for KR
SOLOS
SOLOS Lite
CC-100XP HW6
CC-100 HW6
Myopia Expert 700
MYOPIA EXPERT 700
CA-800
TERA Dry Eye Imager
CA-200
CA-200F
HENSON 9000
Establishment Types
Manufacture Medical Device